A Study of Samuraciclib and Elacestrant in Participants With Metastatic or Locally Advanced HR+/HER2-negative Breast Cancer (SUMIT-ELA)
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| ClinicalTrials.gov Identifier: NCT05963997 |
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Recruitment Status :
Recruiting
First Posted : July 27, 2023
Last Update Posted : May 6, 2024
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Sponsor:
Carrick Therapeutics Limited
Collaborator:
Berlin-Chemie AG Menarini Group
Information provided by (Responsible Party):
Carrick Therapeutics Limited
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Brief Summary:
This is an international, multisite, open-label, Phase 1b/2 study, to confirm safety and efficacy of samuraciclib in combination with elacestrant in adult participants with metastatic or locally advanced Hormone Receptor (HR) positive and Human Epidermal Growth Factor Receptor (HER)2-negative breast cancer.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Metastatic Breast Cancer Locally Advanced Breast Cancer Breast Cancer | Drug: Samuraciclib Drug: Elacestrant Dihydrochloride | Phase 1 Phase 2 |
This is a multiple cohort study, an initial dose escalation phase is designed to confirm the safe dose of samuraciclib in combination with elacestrant. A Safety Review Committee (SRC) will monitor the safety, tolerability, and PK data during this phase. Once ascertained, an expansion cohort will be opened to explore the efficacy of samuraciclib in combination with elacestrant.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 48 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Sequential Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 1b/2 Open-label Study of Samuraciclib in Combination With Elacestrant in Participants With Metastatic or Locally Advanced Hormone Receptor-positive and Human Epidermal Growth Factor Receptor 2-negative Breast Cancer |
| Actual Study Start Date : | October 9, 2023 |
| Estimated Primary Completion Date : | December 23, 2024 |
| Estimated Study Completion Date : | June 16, 2025 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Breast cancer
MedlinePlus related topics:
Breast Cancer
| Arm | Intervention/treatment |
|---|---|
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Experimental: Cohort 1
Up to 6 evaluable participants will receive samuraciclib 240 mg in combination with elacestrant 300 mg in cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onwards).
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Drug: Samuraciclib
Samuraciclib capsules by mouth once a day Drug: Elacestrant Dihydrochloride Elacestrant tablets by mouth once a day
Other Name: ORSERDU |
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Experimental: Cohort 2
Up to 6 evaluable participants will receive samuraciclib in combination with elacestrant at the SRC recommended dose (anticipated 360mg samuraciclib, 300 mg elacestrant) in cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onward).
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Drug: Samuraciclib
Samuraciclib capsules by mouth once a day Drug: Elacestrant Dihydrochloride Elacestrant tablets by mouth once a day
Other Name: ORSERDU |
|
Experimental: Cohort 3
Up to 6 evaluable participants will receive samuraciclib in combination with elacestrant at the SRC recommended dose (anticipated 360mg samuraciclib, 400 mg elacestrant) in cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onward).
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Drug: Samuraciclib
Samuraciclib capsules by mouth once a day Drug: Elacestrant Dihydrochloride Elacestrant tablets by mouth once a day
Other Name: ORSERDU |
|
Experimental: Cohort 4 Expansion
Up to 30 evaluable participants will receive samuraciclib in combination with elacestrant at the SRC recommended dose (anticipated 360mg samuraciclib, 400 mg elacestrant) in cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onward).
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Drug: Samuraciclib
Samuraciclib capsules by mouth once a day Drug: Elacestrant Dihydrochloride Elacestrant tablets by mouth once a day
Other Name: ORSERDU |
Primary Outcome Measures :
- Phase 1b (Dose-finding) [ Time Frame: From the date of first dose of any study intervention (Day 1 Cycle 1) and through 28 days after the last dose of any study intervention ]
Identification of Samuraciclib + Elacestrant combination, Phase 2, expansion dose level.
Incidence and severity of adverse events as graded by the National Cancer Institute Common Terminology Criteria for Adverse events (NCI-CTCAE) v5.0. Safety will be assessed by monitoring treatment - emerged severe and dose limiting adverse events and clinically relevant changes in vital signs and clinical laboratory results
- Phase 2 (Expansion) [ Time Frame: From the date of first dose of any study intervention (Cycle 1 Day 1) until the first documentation of disease progression, death, withdrawal of consent, or start of new anticancer therapy (assessed up to week 48) ]Progression Free Survival (PFS) is defined as the time from the date of first dose of IMP (Cycle 1 Day 1) to the date of the first documentation of objective progressive disease (PD) or death due to any cause, whichever occurs first.
Secondary Outcome Measures :
- Treatment-Emergent Adverse Events and Laboratory Abnormalities (Safety and Tolerability) [ Time Frame: From the date of first dose of any study intervention through 28 days after the last dose of any study intervention ]Type, incidence, severity (as graded by CTCAE v5.0), seriousness and relationship to study medications of AEs and any laboratory abnormalities. Safety will be assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results.
- Clinical Benefit Response (CBR) [ Time Frame: From the date of first dose of any study intervention (Cycle 1 Day 1) to ≥ 24 weeks or until disease progression or death to any cause (assessed up to week 24) ]CBR is defined as the overall complete response (CR), partial response (PR), or stable disease (SD) ≥ 24 weeks according to RECIST version 1.1 recorded from enrolment until disease progression, or death due to any cause.
- Overall response rate (ORR) [ Time Frame: the date of first dose of study intervention (Cycle 1 Day 1) until the first documentation of disease progression, death, withdrawal of consent, or start of new anticancer therapy (assessed up to week 48) ]
ORR is defined as the proportion of participants with a reduction in tumor burden with CR or PR according to RECIST version 1.1.
ORR will be estimated for participants who received at least 1 dose of IMP, had measurable disease at baseline and had a postbaseline tumor assessment.
- Duration of Response (DOR) [ Time Frame: From the date of first dose of study intervention (Cycle 1 Day 1) until the first documentation of disease progression, death, withdrawal of consent, or start of new anticancer therapy (assessed up to week 48) ]DOR is defined as the time from the date of first documentation of objective tumor response (CR or PR) to the earliest documented disease progression per RECIST version 1.1
- Best percent change in tumor size. [ Time Frame: From the date of first dose of study intervention (Cycle 1 Day 1) until the first documentation of disease progression, death, withdrawal of consent, or start of new anticancer therapy (assessed up to week 48) ]Best percent change in tumor size is defined as the percentage change in the sum of the longest diameters of target lesions
- Samuraciclib plasma exposure: Cmax [ Time Frame: Day 1 of Cycles 1 and Cycle 2 (each cycle is 28 days) ]Plasma concentration for Samuraciclib
- Elacestrant exposure: Cmax [ Time Frame: Day 1 of Cycles 1 and Cycle 2 (each cycle is 28 days) ]Plasma concentrations for Elacestrant
- Samuraciclib plasma exposure: Ctrough [ Time Frame: Cycle 1 Day 2 and 15; Day 2 of Cycle 2; Day 1 of Cycles 3-6 and end of treatment within 28 days of last dose of IMP and prior to the initiation of a new anticancer therapy (each cycle is 28 days)] ]
- Elacestrant exposure: Ctrough [ Time Frame: Cycle 1 Day 2 and Day 15; Cycle 2 Day 2 of Cycle 2 and Day 1 of Cycles 3-6 and at end of treatment within 28 days of the last dose of IMP and prior to the initiation of a new anticancer therapy (each cycle is 28 days) ]
- Genotyping for ESR1 and TP53 mutations [ Time Frame: Screening ]Genotyping for ESR1 and TP53 mutations to evaluate correlations between ESR1 and TP53 mutations and efficacy/safety findings
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically confirmed diagnosis of ER-positive, HER2-negative locally advanced or metastatic breast cancer.
- Documented objective disease progression while on or within 6 months after the end of the most recent therapy.
- Received prior AI in combination with a CDK4/6i as the last therapy
- Known TP53 and ESR1 mutation status.
- Participants must have measurable disease or bone only disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Pre/peri-menopausal participants must have commenced treatment with a luteinizing hormone-releasing hormone (LHRH) agonist at least 4 weeks prior to first dose of study intervention.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1 with no deterioration over the past 2 weeks.
- Expected life expectancy of >12 weeks in the judgement of the treating investigator.
Exclusion Criteria:
- Inflammatory breast cancer.
- Participants with any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.
- More than 1 line of endocrine treatment for locally advanced or metastatic disease treatment.
- Inadequate hepatic, renal, and bone marrow function.
- Clinically significant cardiovascular disease.
- Any current or prior central nervous system metastases, carcinomatous meningitis, or leptomeningeal disease.
- Pregnant or breastfeeding women.
Information from the National Library of Medicine
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): NCT05963997
Contacts
| Contact: Clinical Operations | +353 1 5996873 | hello@carricktherapeutics.com |
Locations
Show 27 study locations
Sponsors and Collaborators
Carrick Therapeutics Limited
Berlin-Chemie AG Menarini Group
| Responsible Party: | Carrick Therapeutics Limited |
| ClinicalTrials.gov Identifier: | NCT05963997 |
| Other Study ID Numbers: |
CT7001_003 2023-503846-30-00 ( Registry Identifier: EU CTIS ) 2023-000072-35 ( EudraCT Number ) |
| First Posted: | July 27, 2023 Key Record Dates |
| Last Update Posted: | May 6, 2024 |
| Last Verified: | May 2024 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Carrick Therapeutics Limited:
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Metastatic Breast Cancer Advanced Breast Cancer Breast Cancer HR Positive HER2-Negative |
Additional relevant MeSH terms:
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |