| October 26, 2022
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| November 7, 2022
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| April 26, 2024
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| February 14, 2023
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| February 2026 (Final data collection date for primary outcome measure)
|
- PK Cohort - (Z)-endoxifen steady-state plasma concentrations [ Time Frame: After 4 weeks of treatment ]
(Z)-endoxifen steady-state plasma concentrations (Css) of evaluable subjects who completed at least one cycle of treatment (28 +/- 3 days)
- Treatment Cohort - Endocrine sensitive disease rate based on Ki-67 percent after 4 weeks of treatment [ Time Frame: After 4 weeks of treatment ]
Endocrine sensitive disease rate will be estimated as the percentage of subjects whose 4-week tumor biopsy finds Ki-67 less than or equal to 10 percent among evaluable subjects who began protocol treatment
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- PK Cohort - (Z)-endoxifen steady-state plasma concentrations [ Time Frame: After 4 weeks of treatment ]
(Z)-endoxifen steady-state plasma concentrations (Css) of eligible subjects who completed at least one cycle of treatment (28 +/- 3 days)
- Treatment Cohort - Endocrine sensitive disease rate based on Ki-67 percent after 4 weeks of treatment [ Time Frame: After 4 weeks of treatment ]
Endocrine sensitive disease rate will be estimated as the percentage of subjects whose 4-week tumor biopsy finds Ki-67 less than or equal to 10 percent (or if both breasts are involved, both breast tumor biopsies find Ki-67 less than or equal to 10 percent) among subjects who began protocol treatment
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|
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- PK Cohort - Area under the plasma (Z)-endoxifen concentration-time curve from time zero to last measurable concentration [ Time Frame: Days 1 and 28 ]
Area under the plasma (Z)-endoxifen concentration-time curve from time zero to last measurable concentration (AUC0-24) on Days 1 and 28 of evaluable subjects who completed at least one cycle of treatment (28 +/- 3 days)
- PK Cohort - Area under the plasma (E)-endoxifen concentration-time curve from time zero to last measurable concentration [ Time Frame: Days 1 and 28 ]
Area under the plasma (E)-endoxifen concentration-time curve from time zero to last measurable concentration (AUC0-24) on Days 1 and 28 of evaluable subjects who completed at least one cycle of treatment (28 +/- 3 days)
- PK Cohort - Accumulation and accumulation half-life [ Time Frame: Days 1 and 28 ]
Accumulation and accumulation half-life (Day 28 AUC0-24/Day 1 AUC0-24) of evaluable subjects who completed at least one cycle of treatment (28 +/- 3 days)
- PK Cohort - (Z)-endoxifen steady-state clearance [ Time Frame: up to 28 days ]
(Z)-endoxifen CLss (steady-state clearance) of evaluable subjects who completed at least one cycle of treatment (28 +/- 3 days)
- PK Cohort - (E)-endoxifen steady-state clearance [ Time Frame: up to 28 days ]
(E)-endoxifen CLss (steady-state clearance) of evaluable subjects who completed at least one cycle of treatment (28 +/- 3 days)
- PK Cohort - Maximum plasma (Z)-endoxifen concentration [ Time Frame: up to 28 days ]
Maximum plasma (Z)-endoxifen concentration (Cmax) of evaluable subjects who completed at least one cycle of treatment (28 +/- 3 days)
- PK Cohort - Maximum plasma (E)-endoxifen concentration [ Time Frame: up to 28 days ]
Maximum plasma (E)-endoxifen concentration (Cmax) of evaluable subjects who completed at least one cycle of treatment (28 +/- 3 days)
- PK Cohort - Time to plasma (Z)-endoxifen maximum concentration [ Time Frame: up to 28 days ]
Time to plasma (Z)-endoxifen maximum concentration (Tmax) of evaluable subjects who completed at least one cycle of treatment (28 +/- 3 days)
- PK Cohort - Time to plasma (E)-endoxifen maximum concentration [ Time Frame: up to 28 days ]
Time to plasma (E)-endoxifen maximum concentration (Tmax) of evaluable subjects who completed at least one cycle of treatment (28 +/- 3 days)
- PK Cohort - plasma (Z)-endoxifen concentration [ Time Frame: Day 1 up to 12 weeks and up to end of treatment or up to 24 weeks. ]
Trough concentrations of (Z)-endoxifen for subjects in the Treatment Extension
- PK Cohort - plasma (E)-endoxifen concentration [ Time Frame: Day 1 up to 12 weeks and up to end of treatment or up to 24 weeks. ]
Trough concentrations of (Z)-endoxifen for subjects in the Treatment Extension
- PK Cohort - Treatment Cohort - Endocrine sensitive disease rate based on Ki-67 percent after 4 weeks of treatment [ Time Frame: After 4 weeks of treatment ]
Endocrine sensitive disease rate will be estimated as the percentage of subjects whose 4-week tumor biopsy finds Ki-67 less than or equal to 10 percent among evaluable subjects who began protocol treatment
- Both Cohorts - Incidence of Adverse Events assessed by CTCAE version 5.0 [ Time Frame: Informed consent up to follow up visit or up to 30 weeks ]
Incidence and severity of adverse events per CTCAE by treatment
- Both Cohorts - Incidence of Serious Adverse Events assessed by CTCAE version 5.0 [ Time Frame: Informed consent up to follow up visit or up to 30 weeks ]
Incidence of serious adverse events by treatment
- Both Cohorts - Incidence of Adverse Events Leading to Discontinuation [ Time Frame: Informed consent up to up to end of treatment or up to 24 weeks ]
Incidence of adverse events leading to discontinuation by treatment
- Both Cohorts - Incidence of Dose Reductions [ Time Frame: Day 1 up to time of surgery or up to 27 weeks ]
Proportion of patients who required a dose reduction by treatment arm
- Both Cohorts - Change in estradiol and estrone [ Time Frame: Day 1, up to 4 weeks, up to 12 weeks and up to end of treatment or up to 24 weeks. ]
Median percent change in the E1/E2 ratio
- Both Cohorts - Percentage of subjects whose serum thymidine kinase 1 (TK1) falls below the detection limit after 4 weeks of treatment [ Time Frame: Day 1, up to 4 weeks, up to 12 weeks and up to end of treatment or up to 24 weeks. ]
Percentage of subjects whose serum TK1 falls below the detection limit (< 20 DiviTum units per liter Du/L) after one cycle of treatment among those with detectable serum TK1 levels prior to start of protocol treatment
- Treatment Cohort - Radiographic Response Rate in the breast [ Time Frame: Baseline Assessment up to 12 weeks and up to end of treatment or up to 24 weeks ]
Radiological response by RECIST 1.1
- Treatment Cohort - Pathologic Complete Response per American Joint Committee on Cancer staging system at time of surgery [ Time Frame: At time of surgery or up to 27 weeks ]
Pathologic Complete Response (pCR) at surgery defined as the absence of residual invasive breast cancer on hematoxylin and eosin evaluation of the resected breast specimen and of all sampled lymph nodes (sentinel ± axillary) removed following completion of neoadjuvant systemic therapy
- Treatment Cohort - Pre-Operative Endocrine Prognostic Index at time of surgery [ Time Frame: At time of surgery or up to 27 weeks ]
Rate of Pre-Operative Endocrine Prognostic Index (PEPI) 0 at time of surgery using residual tumor specimen
- Treatment Cohort - Residual Cancer Burden at time of surgery [ Time Frame: At time of surgery or up to 27 weeks ]
Rate of residual cancer burden class of 0-I at time of surgery
- Treatment Cohort - Conversion Rate [ Time Frame: From baseline to time of surgery or up to 27 weeks ]
Evaluate the conversion rate from breast conservation surgery ineligible to breast conservation surgery eligible. Evaluation is based on surgeon's impression of the type of surgery participant is eligible for (candidate for lumpectomy, candidate for modified radical mastectomy, inoperable) at baseline compared to surgeon's impression after completion of neoadjuvant treatment
- Treatment Cohort - Actual Conversion Rate [ Time Frame: At time of surgery or up to 27 weeks ]
Evaluate the actual rate of breast conservation surgery. Evaluation will be based on the extent of the surgical procedure at the time of surgery (lumpectomy, partial or segmental mastectomy, simple/total mastectomy, skin and/or nipple sparing mastectomy, radical mastectomy or other)
- Treatment Cohort - Change in cholesterol levels [ Time Frame: Day 1 up to 4 weeks, up to 12 weeks and up to end of treatment or up to 24 weeks ]
Change from pre-neoadjuvant treatment in cholesterol levels
- Treatment Cohort - Change in blood pressure [ Time Frame: Day 1 up to 4 weeks, up to 12 weeks and up to end of treatment or up to 24 weekss ]
Change from pre-neoadjuvant treatment in blood pressure
|
- PK Cohort - Area under the plasma (Z)-endoxifen concentration-time curve from time zero to last measurable concentration [ Time Frame: Days 1 and 28 ]
Area under the plasma (Z)-endoxifen concentration-time curve from time zero to last measurable concentration (AUC0-24) on Days 1 and 28 of eligible subjects who completed at least one cycle of treatment (28 +/- 3 days)
- PK Cohort - Area under the plasma (E)-endoxifen concentration-time curve from time zero to last measurable concentration [ Time Frame: Days 1 and 28 ]
Area under the plasma (E)-endoxifen concentration-time curve from time zero to last measurable concentration (AUC0-24) on Days 1 and 28 of eligible subjects who completed at least one cycle of treatment (28 +/- 3 days)
- PK Cohort - Accumulation and accumulation half-life [ Time Frame: Days 1 and 28 ]
Accumulation and accumulation half-life (Day 28 AUC0-24/Day 1 AUC0-24) of eligible subjects who completed at least one cycle of treatment (28 +/- 3 days)
- PK Cohort - (Z)-endoxifen steady-state clearance [ Time Frame: up to 28 days ]
(Z)-endoxifen CLss (steady-state clearance) of eligible subjects who completed at least one cycle of treatment (28 +/- 3 days)
- PK Cohort - (E)-endoxifen steady-state clearance [ Time Frame: up to 28 days ]
(E)-endoxifen CLss (steady-state clearance) of eligible subjects who completed at least one cycle of treatment (28 +/- 3 days)
- PK Cohort - Maximum plasma (Z)-endoxifen concentration [ Time Frame: up to 28 days ]
Maximum plasma (Z)-endoxifen concentration (Cmax) of eligible subjects who completed at least one cycle of treatment (28 +/- 3 days)
- PK Cohort - Maximum plasma (E)-endoxifen concentration [ Time Frame: up to 28 days ]
Maximum plasma (E)-endoxifen concentration (Cmax) of eligible subjects who completed at least one cycle of treatment (28 +/- 3 days)
- PK Cohort - Time to plasma (Z)-endoxifen maximum concentration [ Time Frame: up to 28 days ]
Time to plasma (Z)-endoxifen maximum concentration (Tmax) of eligible subjects who completed at least one cycle of treatment (28 +/- 3 days)
- PK Cohort - Time to plasma (E)-endoxifen maximum concentration [ Time Frame: up to 28 days ]
Time to plasma (E)-endoxifen maximum concentration (Tmax) of eligible subjects who completed at least one cycle of treatment (28 +/- 3 days)
- PK Cohort - Treatment Cohort - Endocrine sensitive disease rate based on Ki-67 percent after 4 weeks of treatment [ Time Frame: After 4 weeks of treatment ]
Endocrine sensitive disease rate will be estimated as the percentage of subjects whose 4-week tumor biopsy finds Ki-67 less than or equal to 10 percent (or if both breasts are involved, both breast tumor biopsies find Ki-67 less than or equal to 10 percent) among subjects who began protocol treatment
- Both Cohorts - Incidence of Adverse Events assessed by CTCAE version 5.0 [ Time Frame: Day 1 up to post-surgery follow up visit or up to 28 weeks ]
Incidence and severity of adverse events per CTCAE by treatment
- Both Cohorts - Incidence of Serious Adverse Events assessed by CTCAE version 5.0 [ Time Frame: Day 1 up to post-surgery follow up visit or up to 28 weeks ]
Incidence of serious adverse events by treatment
- Both Cohorts - Incidence of Adverse Events Leading to Discontinuation [ Time Frame: Day 1 up to post-surgery follow up visit or up to 28 weeks ]
Incidence of adverse events leading to discontinuation by treatment
- Both Cohorts - Percentage of subjects whose serum thymidine kinase 1 (TK1) falls below the detection limit after 4 weeks of treatment [ Time Frame: After 4 weeks of treatment ]
Percentage of subjects whose serum TK1 falls below the detection limit (< 20 DiviTum units per liter Du/L) after one cycle of treatment among those with detectable serum TK1 levels prior to start of protocol treatment
- Treatment Cohort - Overall Response Rate according to World Health Organization Criteria assessed by MRI at Week 12 [ Time Frame: Baseline Assessment up to Cycle 3 (each cycle is 28 days) or up to 12 weeks ]
Radiological response (by World Health Organization [WHO] Criteria for Clinical Response) rates at 12 weeks assessed by MRI
- Treatment Cohort - Overall Response Rate according to World Health Organization Criteria assessed by MRI at Week 24 [ Time Frame: Baseline Assessment up to end of treatment visit or up to 24 weeks ]
Radiological response (by World Health Organization [WHO] Criteria for Clinical Response) rates at 24 weeks assessed by MRI
- Treatment Cohort - Pathologic Complete Response per American Joint Committee on Cancer staging system at time of surgery [ Time Frame: At time of surgery or up to 25 weeks ]
Pathologic Complete Response (pCR) at surgery defined as the absence of residual invasive breast cancer on hematoxylin and eosin evaluation of the resected breast specimen and lymph nodes removed following completion of neoadjuvant systemic therapy
- Treatment Cohort - Rate of Pre-Operative Endocrine Prognostic Index at time of surgery [ Time Frame: At time of surgery or up to 25 weeks ]
Rate of Pre-Operative Endocrine Prognostic Index (PEPI) 0 at time of surgery using residual tumor specimen
- Treatment Cohort - Class of Residual Cancer Burden at time of surgery [ Time Frame: At time of surgery or up to 25 weeks ]
Residual cancer burden class of II-III rate at time of surgery
- Treatment Cohort - Conversion Rate [ Time Frame: From baseline to time of surgery or up to 25 weeks ]
Evaluate the conversion rate from breast conservation surgery ineligible to breast conservation surgery eligible. Evaluation is based on surgeon's impression of the type of surgery participant is eligible for (candidate for lumpectomy, candidate for modified radical mastectomy, inoperable) at baseline compared to surgeon's impression after completion of neoadjuvant treatment
- Treatment Cohort - Actual Conversion Rate [ Time Frame: At time of surgery or up to 25 weeks ]
Evaluate the actual rate of breast conservation surgery. Evaluation will be based on the extent of the surgical procedure at the time of surgery (lumpectomy, partial or segmental mastectomy, simple/total mastectomy, skin and/or nipple sparing mastectomy, radical mastectomy or other)
- Treatment Cohort - Change from pre-neoadjuvant treatment in estrone (E1)/estradiol(E2) [ Time Frame: Day 1 up to end of treatment visit or up to 24 weeks ]
Change from pre-neoadjuvant treatment in estrone (E1)/estradiol(E2)
- Treatment Cohort - Change from pre-neoadjuvant treatment in cholesterol levels [ Time Frame: Day 1 up to end of treatment visit or up to 24 weeks ]
Change from pre-neoadjuvant treatment in cholesterol levels
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| Not Provided
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| Not Provided
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| |
| (Z)-Endoxifen for the Treatment of Premenopausal Women With ER+/HER2- Breast Cancer
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| A Randomized Phase 2 Non-inferiority Trial of (Z)-Endoxifen and Exemestane + Goserelin as Neoadjuvant Treatment in Premenopausal Women With ER+/HER2- Breast Cancer
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This open-label research study is studying (Z)-endoxifen as a possible treatment for pre-menopausal (still having periods) women with ER+/HER2- breast cancer. (Z)-endoxifen is a selective estrogen receptor modulator or "SERM." SERMs work to treat cancer by blocking the body's natural estrogen from binding to cancer cells. This study includes a pharmacokinetic part (PK, how the drug works in your body) and a treatment part. The primary purpose of the study is to see how (Z)-endoxifen works on tumor cell growth by monitoring a cancer marker called Ki-67. Ki-67 will be measured by biopsy of the breast after about 4 weeks of treatment. If your cancer is responding to treatment based on the Ki-67 results, you may continue treatment up to 24 weeks or until surgery.
The PK part of the study will be enrolled first, enrolling about 18 study participants who will all receive oral once daily (Z)-endoxifen treatment. 12 of these participants will be randomly assigned to treatment with an equal (50/50) chance to be assigned to (Z)-endoxifen or (Z)-endoxifen + goserelin (a medication given to block the ovaries from making estrogen and is also called ovarian suppression). This part of the study will help select the dose of (Z)-endoxifen to use in the treatment part by measuring the levels of (Z)-endoxifen in the blood stream and determine how long it takes for the body to remove it.
About 160 study participants will be enrolled in the treatment part. The treatment part will help to determine how oral once daily (Z)-endoxifen, when taken by itself, compares to oral once daily exemestane (a medication that decreases the amount of estrogen in the body, also known as an aromatase inhibitor) and monthly injections of goserelin. Exemestane and goserelin taken together is a standard treatment regimen for premenopausal patients with ER+/HER2- breast cancer. Study participants are randomly assigned to treatment with an equal (50/50) chance to be assigned to (Z)-endoxifen or standard treatment.
Study participation is up to 24 weeks of treatment followed by surgery.
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| Not Provided
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| Interventional
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| Phase 2
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Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This multicenter open-label study consists of two cohorts: PK and Treatment
The PK Cohort is a dose finding study to identify the dose to use in the Treatment Cohort.
The Treatment Cohort is a randomized 1:1 two-arm study with potential to switch to a single modified regimen based on Ki-67% at Week 4.
Primary Purpose: Treatment
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- Breast Neoplasms
- Invasive Breast Cancer
- Estrogen-receptor-positive Breast Cancer
- HER2-negative Breast Cancer
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- Drug: (Z)-endoxifen
(Z)-endoxifen capsules. Doses of (Z)-endoxifen to be evaluated include 20 mg (two x 10 mg capsules), 40 mg (one 40 mg capsule) and 80 mg (two x 40 mg capsules).
Other Name: endoxifen
- Drug: exemestane
exemestane tablets 25 mg
Other Name: Aromasin
- Drug: goserelin
goserelin 3.6 mg subcutaneous implant
Other Name: Zoladex
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- Experimental: PK Cohort
(Z)-endoxifen capsules orally once daily for 4 weeks. Initial (Z)-endoxifen dose evaluated will be 40 mg with an option to evaluate 20 mg or 80 mg.
The PK Cohort participants may extend treatment based on Ki-67% at Week 4.
If Ki-67 ≤ 10% at Week 4, participant will be offered option to continue on this treatment for up to 6 cycles/Week 24. Each cycle is 28 days.
If Ki-67 > 10% at Week 4, participant will be withdrawn and go on to surgery. Intervention: Drug: (Z)-endoxifen
- Experimental: Treatment Cohort Arm 1 Initial Regimen
(Z)-endoxifen capsules orally once daily for 4 weeks. Dose will be based on the results of the PK Cohort.
If Ki-67 ≤ 10% at Week 4, continue on this treatment for up to 6 cycles/Week 24. Each cycle is 28 days.
If Ki-67 > 10% at Week 4, participant will be offered modified regimen or be withdrawn and go on to surgery. Intervention: Drug: (Z)-endoxifen
- Active Comparator: Treatment Cohort Arm 2 Initial Regimen
Exemestane 25 mg orally once daily for 4 weeks + goserelin 3.6 mg by subcutaneous implant approximately every 28 days.
If Ki-67 ≤ 10% at Week 4, continue on this treatment for up to 6 cycles/Week 24. Each cycle is 28 days.
If Ki-67 > 10% at Week 4, participant will be offered modified regimen or be withdrawn and go on to surgery. Interventions:
- Drug: exemestane
- Drug: goserelin
- Experimental: Treatment Cohort Arm 1 Modified Regimen
(Z)-endoxifen capsules orally once daily for 4 weeks + goserelin 3.6 mg by subcutaneous implant approximately every 28 days. (Z)-endoxifen dose will be based on the results of the PK Cohort.
If Ki-67 ≤ 10% after 4 weeks of modified regimen, continue on this treatment for up to 6 total treatment cycles/Week 24. Each cycle is 28 days.
If Ki-67 > 10% after 4 weeks of modified regimen, participant will be withdrawn and go on to surgery. Interventions:
- Drug: (Z)-endoxifen
- Drug: goserelin
- Experimental: Treatment Cohort Arm 2 Modified Regimen
(Z)-endoxifen capsules orally once daily for 4 weeks + goserelin 3.6 mg by subcutaneous implant approximately every 28 days. (Z)-endoxifen dose will be based on the results of the PK Cohort.
If Ki-67 ≤ 10% after 4 weeks of modified regimen, continue on this treatment for up to 6 total treatment cycles/Week 24. Each cycle is 28 days.
If Ki-67 > 10% after 4 weeks of modified regimen, participant will be withdrawn and go on to surgery. Interventions:
- Drug: (Z)-endoxifen
- Drug: goserelin
- Experimental: PK Cohort 80 mg
(Z)-endoxifen 80 mg capsules orally once daily for 4 weeks.
The PK Cohort participants may extend treatment based on Ki-67% at Week 4.
If Ki-67 ≤ 10% at Week 4, participant will be offered option to continue on this treatment for up to 6 cycles/Week 24. Each cycle is 28 days.
If Ki-67 > 10% at Week 4, participant will be withdrawn and go on to surgery. Intervention: Drug: (Z)-endoxifen
- Experimental: PK Cohort 80 mg + OFS
(Z)-endoxifen 80 mg capsules orally once daily for 4 weeks + goserelin 3.6 mg by subcutaneous implant approximately every 28 days.
The PK Cohort participants may extend treatment based on Ki-67% at Week 4.
If Ki-67 ≤ 10% at Week 4, participant will be offered option to continue on this treatment for up to 6 cycles/Week 24. Each cycle is 28 days.
If Ki-67 > 10% at Week 4, participant will be withdrawn and go on to surgery. Interventions:
- Drug: (Z)-endoxifen
- Drug: goserelin
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| Not Provided
|
| |
| Recruiting
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| 180
|
| 174
|
| September 2026
|
| February 2026 (Final data collection date for primary outcome measure)
|
Inclusion Criteria:
- Premenopausal women 18 years or older
- Not lactating, pregnant, or planning to become pregnant in the next year
- Agree to use at least one non-hormonal highly effective method of contraception for the entire duration of study participation.
- ER+/HER2-: [ER] ≥ 67% or Allred Score 6-8) / HER2- (histologically confirmed) using American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines
- Clinical T2 or T3 and N0 or N1 invasive breast cancer (per American Joint Committee on Cancer [AJCC] 8th edition clinical staging)
- Nottingham Grade 1 or 2
- ECOG Performance Status (ECOG PS) of 0 to 2
Exclusion Criteria:
- Inflammatory breast cancer; bilateral disease (DCIS/LCIS in contralateral breast OK)
- Prior diagnosis or treatment for breast cancer, including carcinoma in situ, or history of any other active malignancy within the past 2 years prior to study entry
- Uncontrolled intercurrent illness including, but not limited to:
- Ongoing or active infection requiring systemic treatment with strong inhibitors/inducers of CYP450 enzymes (including bacterial infection, fungal infection, or detectable viral infection).
- Symptomatic congestive heart failure, unstable angina pectoris, uncontrolled symptomatic cardiac arrhythmias
- Uncontrolled hypertension (defined as blood pressure > 160/90 mm Hg)
- Uncontrolled diabetes (Hemoglobin A1c [HbA1c] >7%)
- Marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval > 470 milliseconds [msec]) using Fridericia's QT correction formula seen ≤ 28 days of registration
- Known cataracts or retinopathy
- History of deep vein thrombosis (DVT)/pulmonary embolism (PE)
- Known activated protein C (APC) resistance, an inherited coagulation disorder
- Creatine clearance < 60 ml/min
- Total bilirubin ≥ 1.5 x upper limit of normal (ULN)
- Aspartate aminotransferase (AST) or alanine amino transferase (ALT) ≥ 2.5 x ULN
- Platelet count (PLT) ≤ 75,000/mm3
- Hemoglobin (Hb) ≤ 10 g/dL
- Hormonal therapies including birth control and hormone replacement therapy during the study or within 1 week of registration; androgen therapy
- Allergy to endoxifen, goserelin, or exemestane or any of their components
- Participation in another investigational clinical trial ≤ 6 months of registration
- Known metastatic disease
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| Sexes Eligible for Study: |
Female |
|
| 18 Years and older (Adult, Older Adult)
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| No
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|
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| United States
|
|
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| |
| NCT05607004
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| ATOS-Z-201
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| Yes
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| Studies a U.S. FDA-regulated Drug Product: |
Yes |
| Studies a U.S. FDA-regulated Device Product: |
No |
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| Atossa Therapeutics, Inc.
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| Same as current
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| Atossa Therapeutics, Inc.
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| Same as current
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| InClin
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| Principal Investigator: |
Matthew P Goetz, MD |
Mayo Clinic |
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| Atossa Therapeutics, Inc.
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| April 2024
|
