REGN21353 Alone or in Combination With Nezastomig for Metastatic Castration-Resistant Prostate Cancer in Adult Participants
Phase 1/2 Trial of REGN21353 (a STEAP1xCD3 Bispecific Antibody) Administered Alone or in Combination With Nezastomig (a PSMAxCD28 Bispecific Antibody) in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
This study will test an experimental Regeneron drug called REGN21353 ("study drug") to see if it can help treat previously treated prostate cancer that has spread (also called metastatic castration-resistant prostate cancer or mCRPC). Some participants may get additional experimental drugs in combination with REGN21353. These additional drugs are nezastomig and sarilumab. "Experimental" means that the drugs are being tested and have not been approved for use in prostate cancer by a country's national health agency that gives approval for new medicines to be prescribed.
The study is looking at:
- What is the best dose of REGN21353 alone and together with nezastomig for treating prostate cancer
- What side effects REGN21353 alone and together with nezastomig might cause
- How well REGN21353 alone and together with nezastomig works
- How much REGN21353 alone and together with nezastomig is in the blood at different times
- If the body reacts to REGN21353 alone or together with nezastomig, in a way that may cause them to not work as well
- How REGN21353 alone and together with nezastomig could affect prostate cancer, which can help researchers understand why REGN21353 alone or together with nezastomig work better in some than others
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 2 단계
- 1단계
연락처 및 위치
연구 연락처
- 이름: Clinical Trials Administrator
- 전화번호: 844-734-6643
- 이메일: clinicaltrials@regeneron.com
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Key Inclusion Criteria:
- Is male with histologically or cytologically confirmed adenocarcinoma of the prostate without pure small cell carcinoma
- Has metastatic castration-resistant prostate cancer with prostate-specific antigen value as described in the protocol and that has progressed within 6 months prior to screening
- Has received ≥2 lines of prior systemic therapy approved in the metastatic and/or castration-resistant setting (in addition to androgen deprivation therapy) including at least one androgen receptor pathway inhibitor (eg, abiraterone, enzalutamide, apalutamide, or darolutamide)
- Has had either orchiectomy or be on luteinizing hormone-releasing hormone (LHRH) agonist or antagonist therapy with serum testosterone levels as described in the protocol and agree to stay on LHRH agonist or antagonist therapy during the trial
- Is able and willing to provide tumor tissue, either archival or newly obtained
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Has adequate organ, bone marrow, renal and hepatic function
Key Exclusion Criteria:
- Has not recovered (ie, grade ≤1 or baseline) from immune-mediated adverse event within 3 months prior to initiation of trial intervention therapy except for endocrinopathies adequately managed with hormone replacement
- Has permanently discontinued anti-cancer immune modulating therapies due to immune-mediated adverse events
- Has another malignancy that is progressing or requires active treatment, except non-melanoma skin cancer that has undergone potentially curative therapy or any tumor that has been deemed to be effectively treated with definitive local control
- Has ongoing or recent (within 5 years) evidence of significant autoimmune disease (including any history of systemic vasculitis) that required treatment with systemic immunosuppressive treatments
- Has active liver metastases
- Has current evidence of or history of central nervous system metastases as described in the protocol
- Has encephalitis, meningitis, neurodegenerative disease (with the exception of mild dementia that does not interfere with activities of daily living), or uncontrolled seizures in the year prior to first dose of trial intervention
- Has a known history of, or any evidence of, interstitial lung disease or active, noninfectious pneumonitis (past 5 years). A history of radiation pneumonitis in the radiation field is permitted
- Has active or recent infection requiring hospitalization or treatment with intravenous anti-infectives within 2 weeks of first dose of trial intervention
- Has significant cardiovascular disease
Note: Other protocol defined Inclusion/ Exclusion criteria apply
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 순차적 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Module 1: monotherapy
|
Administered per the protocol May be administered as pretreatment, per the protocol
다른 이름들:
|
|
실험적: Module 2: combination
|
Administered per the protocol May be administered as pretreatment, per the protocol
다른 이름들:
Administered per the protocol
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Occurrence of Treatment Emergent Adverse Events (TEAEs)
기간: Up to 5 years
|
Dose escalation |
Up to 5 years
|
|
Occurrence of Dose-Limiting Toxicities (DLTs)
기간: Up to 42 days
|
Dose escalation |
Up to 42 days
|
|
Occurrence of Serious Adverse Events (SAEs)
기간: Up to 5 years
|
Dose escalation |
Up to 5 years
|
|
Occurrence of Adverse Events of Special Interests (AESIs)
기간: Up to 5 years
|
Dose escalation |
Up to 5 years
|
|
Composite Response Rate (CRR) of ≥50% decline of prostate specific antigen (PSA) and/or confirmed radiographic response of complete response (CR) or partial response (PR)
기간: Up to 5 years
|
Dose expansion |
Up to 5 years
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
(CRR) of ≥50% decline of prostate specific antigen (PSA) and/or confirmed radiographic response of complete response (CR) or partial response (PR)
기간: Up to 5 years
|
Dose escalation |
Up to 5 years
|
|
Occurrence of TEAEs
기간: Up to 5 years
|
Dose expansion |
Up to 5 years
|
|
Occurrence of SAEs
기간: Up to 5 years
|
Dose expansion |
Up to 5 years
|
|
Occurrence of AESIs
기간: Up to 5 years
|
Dose expansion |
Up to 5 years
|
|
Percentage of participants with ≥50% reduction in PSA confirmed by a second PSA test ≥3 weeks later
기간: Up to 5 years
|
Dose Escalation and Dose Expansion |
Up to 5 years
|
|
Percentage of participants with ≥90% reduction in PSA confirmed by a second PSA test ≥3 weeks later
기간: Up to 5 years
|
Dose Escalation and Dose Expansion |
Up to 5 years
|
|
REGN21353 serum concentrations
기간: Up to 5 years
|
Dose Escalation and Dose Expansion |
Up to 5 years
|
|
Nezastomig serum concentrations
기간: Up to 5 years
|
Dose Escalation and Dose Expansion |
Up to 5 years
|
|
Occurrence of Anti-Drug Antibodies (ADA) to REGN21353
기간: Up to 5 years
|
Dose Escalation and Dose Expansion |
Up to 5 years
|
|
Occurrence of ADA to nezastomig
기간: Up to 5 years
|
Dose Escalation and Dose Expansion |
Up to 5 years
|
|
Magnitude of ADA to REGN21353
기간: Up to 5 years
|
Dose Escalation and Dose Expansion |
Up to 5 years
|
|
Magnitude of ADA to nezastomig
기간: Up to 5 years
|
Dose Escalation and Dose Expansion |
Up to 5 years
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Clinical Trial Management, Regeneron Pharmaceuticals
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- R21353-ONC-25105
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
IPD 공유 기간
When Regeneron has:
- received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
- made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
- the legal authority to share the data, and
- ensured the ability to protect participant privacy
IPD 공유 액세스 기준
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- ANALYTIC_CODE
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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