이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

전이성 거세 저항성 전립선암 환자에서 REGN5678(Anti-PSMAxCD28)과 Cemiplimab(Anti-PD-1)의 연구

2026년 11월 3일 업데이트: Regeneron Pharmaceuticals

전이성 거세 저항성 전립선암 환자에서 Cemiplimab(Anti-PD-1)과 REGN5678(Anti-PSMAxCD28)의 1/2상 연구

The main purpose of this study is to determine the safety, tolerability (how the body reacts to the drug[s]) and effectiveness (ability to treat the cancer) of REGN5678 (Nezastomig) alone, or in combination with cemiplimab.

The study has 2 parts. The goal of Part 1 (dose escalation) is to determine a safe dose(s) of REGN5678 when it is given alone or in combination with cemiplimab. The goal of Part 2 (dose expansion) is to use the REGN5678 drug dose(s) found in Part 1 to see how well REGN5678 alone or in combination with cemiplimab works to shrink tumors.

This study is looking at several other research questions, including:

  1. Side effects that may be experienced by taking REGN5678 alone or in combination with cemiplimab
  2. How REGN5678 alone or in combination with cemiplimab works in the body
  3. How much REGN5678 and/or cemiplimab are present in the blood
  4. To see if REGN5678 alone or in combination with cemiplimab works to reduce the size of the tumor by helping the immune system destroy the tumor

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

345

단계

  • 2 단계
  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 대한민국
      • Seoul, 대한민국, 05505
        • 모병
        • Asan Medical Center
      • Seoul, 대한민국, 03722
        • 모병
        • Yonsei University - Severance Hospital - Colorectal Cancer Clinic
    • Gyeonggi-do
      • Suwon, Gyeonggi-do, 대한민국, 16247
        • 모병
        • The Catholic University of Korea - St. Vincent's Hospital - Lung Cancer Center
  • 미국
    • Arizona
      • Gilbert, Arizona, 미국, 85234
        • 모병
        • Banner MD Anderson Cancer Center
      • Phoenix, Arizona, 미국, 85054
        • 모병
        • Mayo Clinic
      • Tucson, Arizona, 미국, 85724
        • 모병
        • University of Arizona
    • California
      • Santa Monica, California, 미국, 90404
        • 모병
        • John Wayne Cancer Institute (JWCI)
    • Colorado
      • Denver, Colorado, 미국, 80218
        • 모병
        • Sarah Cannon Research Institute (SCRI)
    • Connecticut
      • New Haven, Connecticut, 미국, 06510
        • 모병
        • Yale University Hospital
    • Florida
      • Jacksonville, Florida, 미국, 32224
        • 모병
        • Mayo Clinic Jacksonville
      • Tampa, Florida, 미국, 33612
        • 모병
        • Moffitt Cancer Center - McKinley Drive
    • Massachusetts
      • Boston, Massachusetts, 미국, 02114
        • 모병
        • Massachusetts General Hospital
    • Michigan
      • Detroit, Michigan, 미국, 48202
        • 모병
        • Henry Ford Health
    • Minnesota
      • Rochester, Minnesota, 미국, 55905
        • 모병
        • Mayo Clinic
    • New York
      • New York, New York, 미국, 10029
        • 모병
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, 미국, 10461
        • 모병
        • Montefiore Medical Center
      • New York, New York, 미국, 10016
        • 모병
        • NYU Langone Health Perlmutter Cancer Center
      • New York, New York, 미국, 10032
        • 모병
        • Columbia University - The Trustees of Columbia University in the City of New York
      • Rochester, New York, 미국, 14642
        • 모병
        • University of Rochester Medical Center (URMC) - Wilmot Cancer Institute (WCI) (James P. Wilmot Cancer Center) - Rochester
    • Ohio
      • Columbus, Ohio, 미국, 43210
        • 모병
        • James Cancer Hospital and Solove Research Institute
    • Oregon
      • Portland, Oregon, 미국, 97213
        • 빼는
        • Providence Portland Medical Center
      • Portland, Oregon, 미국, 97239
        • 모병
        • Oregon Health & Science University (3485 S. Bond)
    • Pennsylvania
      • Philadelphia, Pennsylvania, 미국, 19107
        • 모병
        • Thomas Jefferson University Hospital
    • Rhode Island
      • Providence, Rhode Island, 미국, 02903
        • 모병
        • Lifespan Cancer Institute
    • Texas
      • Houston, Texas, 미국, 77030
        • 모병
        • MD Anderson Cancer Center
    • Virginia
      • Charlottesville, Virginia, 미국, 22908
        • 모병
        • Emily Couric Clinical Cancer Center
    • West Virginia
      • Morgantown, West Virginia, 미국, 26506
        • 모병
        • West Virginia University

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Key Inclusion Criteria:

mCRPC cohorts (men):

  1. Men with histologically or cytologically confirmed adenocarcinoma of the prostate without pure small cell carcinoma.

  2. PSA value at screening ≥4 ng/mL that has progressed within 6 months prior to screening as defined in the protocol.

  3. Has received ≥2 lines prior systemic therapy approved in the metastatic and/or castration-resistant setting (in addition to Androgen Deprivation Therapy [ADT]) including at least:

    1. one second-generation anti-androgen therapy (eg, abiraterone, enzalutamide, apalutamide, or darolutamide)
    2. 177Lu-PSMA-617 radiotherapy, or another lutetium-based PSMA targeted radioligand, as described in the protocol

ccRCC cohorts (men and women):

  1. Histologically or cytologically confirmed RCC with a clear-cell component.
  2. Diagnosis of metastatic ccRCC with at least one measurable lesion via RECIST 1.1 criteria
  3. Has progressed on or after ≥1 line prior systemic therapy approved in the metastatic setting. Prior treatment must include an anti-Programmed Death-1 (receptor) [PD-1]/Programmed Death-Ligand 1 (PD-L1) therapy and either ipilimumab and/or a tyrosine kinase inhibitor

Key Exclusion Criteria:

  1. Has received treatment with an approved systemic therapy within 3 weeks of dosing or has not yet recovered (ie, grade ≤1 or baseline) from any acute toxicities, as described in the protocol
  2. Has received any previous systemic biologic therapy within 5 half-lives of first dose of study therapy, as described in the protocol
  3. Has received prior PSMA-targeting therapy with the exception of a PSMA targeting radioligand (eg. 177Lu-PSMA-617) in mCRPC
  4. Dose Escalation: Has had prior anti-cancer immunotherapy (other than sipuleucel-T) within 5 half-lives prior to study therapy.
  5. Dose Expansion (mCRPC only): Has had prior anti-cancer immunotherapy, as described in the protocol
  6. Any condition that requires ongoing/continuous corticosteroid therapy (>10 mg prednisone/day or anti-inflammatory equivalent) within 1 week prior to the first dose of study therapy
  7. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, as described in the protocol
  8. Encephalitis, meningitis, neurodegenerative disease (with the exception of mild dementia that does not interfere with Activities of Daily Living [ADLs]) or uncontrolled seizures in the year prior to first dose of study therapy
  9. Uncontrolled infection with Human Immunodeficiency Virus (HIV), hepatitis B or hepatitis C infection; or diagnosis of immunodeficiency

NOTE: Other protocol defined Inclusion/Exclusion Criteria apply

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위화되지 않음
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: mCRPC - dose escalation cohort

REGN5678 with or without cemiplimab
의약품: REGN5678

Administered as per the protocol

다른 이름들:
  • 네자스토미그
의약품: Cemiplimab

Administered as per the protocol

다른 이름들:
  • REGN2810
  • 립타요
실험적: mCRPC - dose expansion cohort

REGN5678 with or without cemiplimab
의약품: REGN5678

Administered as per the protocol

다른 이름들:
  • 네자스토미그
실험적: ccRCC - dose escalation cohort

REGN5678 with or without cemiplimab
의약품: REGN5678

Administered as per the protocol

다른 이름들:
  • 네자스토미그
의약품: Cemiplimab

Administered as per the protocol

다른 이름들:
  • REGN2810
  • 립타요
실험적: ccRCC - dose expansion cohort

REGN5678 with or without cemiplimab
의약품: REGN5678

Administered as per the protocol

다른 이름들:
  • 네자스토미그

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Incidence and severity of Treatment-Emergent Adverse Events (TEAEs)
기간: Through study completion, up to 5 years

Dose Escalation Phase
Through study completion, up to 5 years
Incidence and severity of Adverse Event of Special Interests (AESIs)
기간: Through study completion, up to 5 years

Dose Escalation Phase
Through study completion, up to 5 years
Incidence and severity of Serious Adverse Events (SAEs)
기간: Through study completion, up to 5 years

Dose Escalation Phase
Through study completion, up to 5 years
Number of participants with Grade ≥3 laboratory abnormalities
기간: Through study completion, up to 5 years

Dose Escalation Phase
Through study completion, up to 5 years
Incidence of Dose-Limiting Toxicities (DLTs)
기간: First dose through day 42 of last participant in each dose level

Dose Escalation Phase
First dose through day 42 of last participant in each dose level
Concentration of REGN5678 in serum over time
기간: Through study completion, up to 5 years

Dose Escalation Phase
Through study completion, up to 5 years
Concentration of REGN5678 in combination with cemiplimab in serum over time
기간: Through study completion, up to 5 years

Dose Escalation Phase
Through study completion, up to 5 years
Composite Response Rate (CRR) of 50% decline of Prostate Specific Antigen (PSA) and/or confirmed radiographic response of complete (CR) or partial response (PR)
기간: Through study completion, up to 5 years

Dose Expansion Phase - mCRPC cohort
Through study completion, up to 5 years
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
기간: Through study completion, up to 5 years

Dose Expansion Phase - ccRCC cohort
Through study completion, up to 5 years

2차 결과 측정

결과 측정
측정값 설명
기간
CRR of 50% decline of PSA and/or confirmed radiographic of CR or PR
기간: Through study completion, up to 5 years

Dose Escalation Phase - mCRPC cohort
Through study completion, up to 5 years
ORR per RECIST 1.1 criteria
기간: Through study completion, up to 5 years

Dose Escalation Phase - ccRCC cohort
Through study completion, up to 5 years
Incidence and severity of TEAEs
기간: Through study completion, up to 5 years

Dose Expansion Phase
Through study completion, up to 5 years
Incidence and severity of AESIs
기간: Through study completion, up to 5 years

Dose Expansion Phase
Through study completion, up to 5 years
Incidence and severity of SAEs
기간: Through study completion, up to 5 years

Dose Expansion Phase
Through study completion, up to 5 years
Number of participants with grade ≥3 laboratory abnormalities
기간: Through study completion, up to 5 years

Dose Expansion Phase
Through study completion, up to 5 years
Concentration of REGN5678 in serum over time
기간: Through study completion, up to 5 years

Dose Expansion Phase
Through study completion, up to 5 years
Concentration of REGN5678 in combination with cemiplimab in serum over time
기간: Through study completion, up to 5 years

Dose Expansion Phase
Through study completion, up to 5 years
Percentage of participants with ≥50% decline of PSA
기간: Through study completion, up to 5 years

Dose Escalation and Dose Expansion Phases - mCRPC cohorts
Through study completion, up to 5 years
Percentage of participants with ≥90% decline of PSA
기간: Through study completion, up to 5 years

Dose Escalation and Dose Expansion Phases- mCRPC cohorts
Through study completion, up to 5 years
Presence or absence of antibodies against REGN5678
기간: Through study completion, up to 5 years

Dose Escalation and Dose Expansion Phases
Through study completion, up to 5 years
Presence or absence of antibodies against cemiplimab
기간: Through study completion, up to 5 years

Dose Escalation and Dose Expansion Phases
Through study completion, up to 5 years

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Regeneron Pharmaceuticals

수사관

  • 연구 책임자: Clinical Trials Management, Regeneron Pharmaceuticals

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2019년 8월 12일

기본 완료 (추정된)

2027년 11월 15일

연구 완료 (추정된)

2027년 11월 15일

연구 등록 날짜

최초 제출

2019년 5월 30일

QC 기준을 충족하는 최초 제출

2019년 5월 30일

처음 게시됨 (실제)

2019년 6월 3일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 4일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 3일

마지막으로 확인됨

2026년 11월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • R5678-ONC-1879

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

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

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다