Clinical Study of Antibody-Drug Conjugate MYTX-011 in Subjects With Non-Small Cell Lung Cancer
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ClinicalTrials.gov Identifier: NCT05652868 |
Recruitment Status :
Recruiting
First Posted : December 15, 2022
Last Update Posted : April 3, 2024
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
NSCLC NSCLC Stage IV NSCLC Stage IIIB Non-Small Cell Lung Cancer Advanced Non-Small Cell Squamous Lung Cancer Advanced Non-Small Cell Lung Cancer Advanced Non-Small Cell Non-Squamous Lung Cancer | Drug: MYTX-011 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 150 participants |
Allocation: | Non-Randomized |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1 Multicenter Dose Escalation and Dose Expansion Study of Antibody-Drug Conjugate MYTX-011 in Subjects With Non-Small Cell Lung Cancer - KisMET-01 |
Actual Study Start Date : | March 23, 2023 |
Estimated Primary Completion Date : | December 2025 |
Estimated Study Completion Date : | December 2027 |
Arm | Intervention/treatment |
---|---|
Experimental: Part 1 Dose Escalation
Part 1 patients will receive MYTX-011.
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Drug: MYTX-011
MYTX-011 will be administered as an intravenous infusion every 21 days. |
Experimental: Part 2 Cohort A
Part 2 Cohort A patients will be randomized to two different dose levels of MYTX-011. Doses to be determined after completion of Part 1.
|
Drug: MYTX-011
MYTX-011 will be administered as an intravenous infusion every 21 days. |
Experimental: Part 2 Cohort B
Part 2 Cohort B patients will receive MYTX-011 at the recommended phase 2 dose.
|
Drug: MYTX-011
MYTX-011 will be administered as an intravenous infusion every 21 days. |
Experimental: Part 2 Cohort C
Part 2 Cohort C patients will receive MYTX-011 at the recommended phase 2 dose.
|
Drug: MYTX-011
MYTX-011 will be administered as an intravenous infusion every 21 days. |
Experimental: Part 2 Cohort D
Part 2 Cohort D patients will receive MYTX-011 at the recommended phase 2 dose.
|
Drug: MYTX-011
MYTX-011 will be administered as an intravenous infusion every 21 days. |
Experimental: Part 2 Cohort E
Part 2 Cohort E patients will receive MYTX-011 at the recommended phase 2 dose.
|
Drug: MYTX-011
MYTX-011 will be administered as an intravenous infusion every 21 days. |
- Part 1: Number of patients with dose limiting toxicity (DLT) [ Time Frame: Up to Day 21 ]The dose limiting toxicities will be based on number and severity of treatment-related adverse events.
- Part 2: Number of patients with tumor response [ Time Frame: 2 years ]The overall response rate will be based on number of complete responses and partial responses.
- Part 1: Pharmacokinetic (PK) parameter (Total ADC) [ Time Frame: 24 months ]Total ADC
- Part 1: Pharmacokinetic (PK) parameter (Total antibody) [ Time Frame: 24 months ]Total antibody
- Part 1: Pharmacokinetic (PK) parameter (Free MMAE) [ Time Frame: 24 months ]Free MMAE
- Part 1: ADA [ Time Frame: 24 months ]Presence of anti-drug antibodies
- Part 1: ORR [ Time Frame: 24 months ]Complete response + partial response
- Part 1: DOR, TTR, DCR [ Time Frame: 2 years ]Duration of response in patients that achieve CR or PR, time to response, best overall response and disease control rate
- Part 1: PFS [ Time Frame: for up to 2 years after end of treatment ]Progression free survival
- Part 1: OS [ Time Frame: for up to 2 years after end of treatment ]Overall survival
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Part 1:
- Histologically or cytologically confirmed locally advanced, recurrent or metastatic NSCLC and have received available standard of care therapy.
- There is no limit on the number of prior therapies that can have been received.
Part 2:
Cohort A:
- Have histologically or cytologically confirmed locally advanced, recurrent (and not a candidate for curative therapy), or metastatic non-squamous NSCLC.
- Tumor sample with high cMET expression by IHC confirmed by central laboratory testing.
Cohort B:
- Have histologically or cytologically confirmed locally advanced, recurrent (and not a candidate for curative therapy), or metastatic non-squamous NSCLC.
- Tumor sample with intermediate cMET expression by IHC confirmed by central laboratory testing.
Cohort C:
- Have histologically or cytologically confirmed locally advanced, recurrent (and not a candidate for curative therapy), or metastatic squamous NSCLC.
- Tumor sample with cMET overexpression by IHC confirmed by central laboratory testing.
Cohort D:
- Have histologically or cytologically confirmed locally advanced, recurrent (and not a candidate for curative therapy), or metastatic NSCLC.
- Tumor sample that does not meet cMET IHC entry criteria for Cohorts A-C
- Known MET amplification or exon 14 skipping mutations respectively. Patients with MET exon 14 skipping mutations must have received MET TKI therapy if available and considered standard of care.
Cohort E:
- Have histologically or cytologically confirmed locally advanced, recurrent (and not a candidate for curative therapy), or metastatic NSCLC.
- Evidence of cMET expression by IHC as documented in medical records.
- No more than 3 prior lines of systemic therapy including prior cMET targeted ADC or antibody.
Part 2 Cohorts A-D
- No more than two prior lines of therapy in the locally advanced/metastatic setting.
Part 2 Cohorts A-E:
- Known to not have an actionable EGFR mutation. Patients with or without other driver mutations are permitted to enroll.
- Patients without any actionable gene alteration: must have progressed on (or be considered ineligible for) standard of care therapy
- Patients with actionable gene alterations (other than EGFR) must have progressed on (or be considered ineligible for) or be intolerant to anti-cancer therapy targeting driver gene alterations and available standard of care therapy
All patients (Part 1 and Part 2)
- Patient has at least one measurable lesion per RECIST 1.1
- ECOG performance status 0 or 1
- For women of childbearing potential and men with partners of childbearing potential, agreement to use a highly effective method of birth control for the duration of the study treatment and for at least 6 months after the last dose of study drug.
- Able to provide informed consent, and willing and able to comply with study protocol requirements
Exclusion Criteria:
- Radiation to the lung within 2 months prior to screening.
- Major surgery within 28 days of first dose of study drug administration.
- Untreated, uncontrolled CNS metastases.
- History of interstitial lung disease or pneumonitis that required treatment with systemic steroids or evidence of active interstitial lung disease or pneumonitis. A history of prior radiation pneumonitis in the radiation field (fibrosis) is permitted.
- Clinically significant systemic illness that could pose undue risk to the subject or confound the ability to interpret study results.
- Active infection requiring IV antibiotics, antivirals, or antifungal medication
- Neuropathy > Grade 1
- History of cirrhosis, hepatic fibrosis, esophageal or gastric varices, or other clinically significant liver disease.
- Active or chronic corneal disorder
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05652868
Contact: William T Downing | 1-833-888-1138 | clinicalsupport@mythictx.com | |
Contact: Lisa Haystrand, MSc | 1-833-888-1138 | clinicalsupport@mythictx.com |
United States, California | |
KisMET-01 Clinical Site | Recruiting |
Santa Monica, California, United States, 90404 | |
Contact: Lisa Haystrand, MSc 833-888-1138 clinicalsupport@mythictx.com | |
Contact: William T Downing 833-888-1138 clinicalsupport@mythictx.com | |
United States, Illinois | |
KisMET-01 Clinical Site | Recruiting |
Rolling Meadows, Illinois, United States, 60008 | |
Contact: William T Downing 833-888-1138 clinicalsupport@mythictx.com | |
Contact: Lisa Haystrand, MSc 833-888-1138 clinicalsupport@mythictx.com | |
United States, Massachusetts | |
KisMET-01 Clinical Site | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Lisa Haystrand, MSc 833-888-1138 clinicalsupport@mythictx.com | |
Contact: William T Downing 833-888-1138 clinicalsupport@mythictx.com | |
United States, Nebraska | |
KisMET-01 Clinical Site | Recruiting |
Omaha, Nebraska, United States, 68130 | |
Contact: Lisa Haystrand, MSc 833-888-1138 clinicalsupport@mythictx.com | |
Contact: William T Downing 833-888-1138 clinicalsupport@mythictx.com | |
United States, New Jersey | |
KisMET-01 Clinical Site | Recruiting |
Morristown, New Jersey, United States, 07960 | |
Contact: Lisa Haystrand, MSc 833-888-1138 clinicalsupport@mythictx.com | |
Contact: William T Downing 1-833-888-1138 clinicalsupport@mythictx.com | |
United States, New York | |
KisMET-01 Clinical Site | Recruiting |
Mineola, New York, United States, 11501 | |
Contact: Lisa Haystrand, MS 833-888-1138 clinicalsupport@mythictx.com | |
Contact: William T Downing 833-888-1138 clinicalsupport@mythictx.com | |
KisMET-01 Clinical Site | Recruiting |
New York, New York, United States, 10016 | |
Contact: Lisa Haystrand, MS 833-888-1138 clinicalsupport@mythictx.com | |
Contact: William T Downing 833-888-1138 clinicalsupport@mythictx.com | |
United States, Pennsylvania | |
KisMET-01 Clinical Site | Recruiting |
Pittsburgh, Pennsylvania, United States, 15232 | |
Contact: Lisa Haystrand, MSc 833-888-1138 clinicalsupport@mythictx.com | |
Contact: William T Downing 833-888-1138 clinicalsupport@mythictx.com | |
United States, South Carolina | |
KisMET-01 Clinical Site | Recruiting |
Charleston, South Carolina, United States, 29425 | |
Contact: Lisa Haystrand, MSc 833-888-1138 clinicalsupport@mythictx.com | |
Contact: William T Downing 833-888-1138 clinicalsupport@mythictx.com | |
United States, Tennessee | |
KisMET-01 Clinical Site | Recruiting |
Nashville, Tennessee, United States, 37203 | |
Contact: Lisa Haystrand, MSc 833-888-1138 clinicalsupport@mythictx.com | |
Contact: William T Downing 833-888-1138 clinicalsupport@mythictx.com | |
United States, Texas | |
KisMET-01 Clinical Site | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: William T Downing 833-888-1138 clinicalsupport@mythictx.com | |
Contact: Lisa Haystrand, MSc 833-888-1138 clinicalsupport@mythictx.com | |
United States, Virginia | |
KisMET-01 Clinical Site | Recruiting |
Fairfax, Virginia, United States, 22031 | |
Contact: Lisa Haystrand, MSc 833-888-1138 clinicalsupport@mythictx.com | |
Contact: William T Downing 833-888-1138 clinicalsupport@mythictx.com | |
United States, Wisconsin | |
KisMET-01 Clinical Site | Recruiting |
Milwaukee, Wisconsin, United States, 53226 | |
Contact: William T Downing 833-888-1138 clinicalsupport@mythictx.com | |
Contact: Lisa Haystrand, MS 8338881138 clinicalsupport@mythictx.com | |
Australia, New South Wales | |
KisMET-01 Clinical Site | Recruiting |
Blacktown, New South Wales, Australia, 2148 | |
Contact: Lisa Haystrand, MSc +1-833-888-1138 clinicalsupport@mythictx.com | |
Contact: William T Downing +1-833-888-1138 clinicalsupport@mythictx.com | |
KisMET-01 Clinical Site | Recruiting |
Camperdown, New South Wales, Australia, 2050 | |
Contact: William T Downing +18338881138 clinicalsupport@mythictx.com | |
Contact: Lisa Haystrand, MSc +18338881138 clinicalsupport@mythictx.com | |
Australia, South Australia | |
KisMET-01 Clinical Site | Recruiting |
Adelaide, South Australia, Australia, 5000 | |
Contact: Lisa Haystrand, MSc +1-833-888-1138 clinicalsupport@mythictx.com | |
Contact: William T Downing +1-833-888-1138 clinicalsupport@mythictx.com | |
KisMET-01 Clinical Site | Recruiting |
Adelaide, South Australia, Australia, 5011 | |
Contact: Lisa Haystrand, MSc +1-833-888-1138 clinicalsupport@mythictx.com | |
Contact: William T Downing +1-833-888-1138 clinicalsupport@mythictx.com | |
Korea, Republic of | |
MYTX-011-01 Clinical Site | Recruiting |
Goyang, Korea, Republic of, 10408 | |
Contact: William T Downing +1-833-888-1138 clinicalsupport@mythictx.com | |
Contact: Lisa Haystrand, MSc +1-833-888-1138 clinicalsupport@mythictx.com | |
KisMET-01 Clinical Site | Recruiting |
Incheon, Korea, Republic of, 21565 | |
Contact: William T Downing +18338881138 clinicalsupport@mythictx.com | |
Contact: Lisa Haystrand, MSc +18338881138 clinicalsupport@mythictx.com | |
KisMET-01 Clinical Site | Recruiting |
Seoul, Korea, Republic of, 03080 | |
Contact: William T Downing +18338881138 clinicalsupport@mythictx.com | |
Contact: Lisa Haystrand, MSc +18338881138 clinicalsupport@mythictx.com | |
KisMET-01 Clinical Site | Recruiting |
Seoul, Korea, Republic of, 03722 | |
Contact: William T Downing +18338881138 clinicalsupport@mythictx.com | |
Contact: Lisa Haystrand, MSc +18338881138 clinicalsupport@mythictx.com | |
United Kingdom | |
KisMET-01 Clinical Site | Recruiting |
Oxford, United Kingdom, OX3 7LJ | |
Contact: William T Downing +18338881138 clinicalsupport@mythictx.com | |
Contact: Lisa Haystrand, MSc +18338881138 clinicalsupport@mythictx.com |
Study Director: | Ting Wu, MD MSc | Mythic Therapeutics |
Responsible Party: | Mythic Therapeutics |
ClinicalTrials.gov Identifier: | NCT05652868 |
Other Study ID Numbers: |
MYTX-011-01 KisMET-01 ( Other Identifier: Mythic Therapeutics ) |
First Posted: | December 15, 2022 Key Record Dates |
Last Update Posted: | April 3, 2024 |
Last Verified: | April 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Supporting Materials: |
Clinical Study Report (CSR) |
Time Frame: | At the conclusion of the study |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
cMET MYTX-011 Mythic MET |
MYTX011 ADC KisMET-01 |
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |