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

GI-102 (CD80-IgG4 Fc-IL2v3) in Combination With Pasritamig in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC) (JET-201)

2026년 11월 4일 업데이트: GI Innovation, Inc.

A Phase 1b/2, Open-label, Multi-center Study to Evaluate the Anti-cancer Activity, Safety and Tolerability of GI-102 (CD80-IgG4 Fc-IL2v3) in Combination With Pasritamig [T-CELL-Redirecting Agent Targeting Human Kallikrein 2 (KLK2)] in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC) Who Progressed on Previous Novel Hormonal Therapy (NHT) (JET-201)

The purpose of this clinical trial is to evaluate the safety, tolerability, and preliminary anti-cancer activity of GI-102 in combination with pasritamig in adult men with metastatic castration-resistant prostate cancer (mCRPC) whose cancer has progressed after previous treatment with a novel hormonal therapy (NHT).

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

107

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
        • 수석 연구원:
          • Jae Lyun Lee, M.D., Ph.D.
      • Seoul, 대한민국, 03722
        • 모병
        • Yonsei University Health System, Severance Hospital
        • 수석 연구원:
          • Sang Joon Shin, M.D., Ph.D.
    • Banpo-daero
      • Seoul, Banpo-daero, 대한민국, 06591
        • 모병
        • The Catholic University of Korea Seoul ST.MARY'S Hospital
        • 수석 연구원:
          • In Ho Kim
    • Seongbuk-gu
      • Seoul, Seongbuk-gu, 대한민국, 02841
        • 모병
        • Korea University Anam Hospital
        • 수석 연구원:
          • Jwa Hoon Kim, M.D.
    • Yangcheon-gu
      • Seoul, Yangcheon-gu, 대한민국, 07985
        • 모병
        • Ewha Womans University Mokdong Hospital
        • 수석 연구원:
          • Jeong Min Cho
  • 미국
    • New York
      • New York, New York, 미국, 10032
        • 아직 모집하지 않음
        • Columbia University Medical Center
        • 수석 연구원:
          • Mark N. Stein, M.D.

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

남성

설명

Key Inclusion Criteria:

  • Male participants aged ≥18 years (or ≥19 years according to local regulatory requirements).
  • ECOG performance status of 0 to 1.
  • Histologically confirmed advanced prostate adenocarcinoma with measurable or evaluable disease. Adenocarcinoma with small cell or neuroendocrine (NE) features is permitted. However, primary small cell carcinoma, carcinoid tumor, mixed NE carcinoma, or large cell NE carcinoma (or pathologic evidence of conversion to) is disallowed.
  • Metastatic castration-resistant prostate cancer (mCRPC) with documented disease progression following at least one line of novel androgen receptor-targeted therapy.
  • PSA ≥2 ng/mL at screening.
  • No more than 2 prior taxane regimens and no prior cytotoxic chemotherapy other than taxane therapy.
  • Prior orchiectomy or ongoing androgen deprivation therapy with castrate testosterone levels.
  • Adequate organ and marrow function and adequate cardiovascular function.
  • Adequate recovery from prior anticancer therapy-related adverse events.
  • Willingness and ability to comply with study procedures and protocol-specified contraception requirements.

Key Exclusion Criteria:

  • Active or prior CNS metastases, carcinomatous meningitis, or clinically unstable spinal cord compression.
  • Significant uncontrolled cardiovascular, pulmonary, hepatic, autoimmune, infectious, or other systemic disease.
  • Active or recent clinically significant infection, including active tuberculosis, hepatitis B, or hepatitis C.
  • Active pneumonitis or interstitial lung disease (ILD), or history of clinically significant pneumonitis/ILD.
  • Recent treatment with investigational products, prohibited immunomodulating agents, radiotherapy, major surgery, or other protocol-defined prohibited therapies.
  • Prior treatment with CD3-directed therapies, including KLK2-CD3 bispecific antibodies or other CD3-targeting T-cell engagers.
  • Known hypersensitivity to GI-102, pasritamig, or their excipients, or any other condition that may interfere with study participation or interpretation of results.

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: 순차적 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Safety run-in: GI-102 + pasritamig (Schedule A)

Participants receive GI-102 in combination with pasritamig during the Safety run-in phase. Dose escalation is guided by a Bayesian Optimal Interval (BOIN) design.
의약품: GI-102

GI-102 will be administered in accordance with the procedures specified in the study protocol.

의약품: Pasritamig

Pasritamig will be administered in accordance with the procedures specified in the study protocol.
실험적: Safety run-in: GI-102 + pasritamig (Schedule B)

Participants receive GI-102 in combination with pasritamig during the Safety run-in phase. Dose escalation is guided by a Bayesian Optimal Interval (BOIN) design.
의약품: GI-102

GI-102 will be administered in accordance with the procedures specified in the study protocol.

의약품: Pasritamig

Pasritamig will be administered in accordance with the procedures specified in the study protocol.
실험적: Expansion

Participants enrolled in the Expansion phase will receive the combination recommended Phase 2 regimen (cRP2R) of GI-102 and pasritamig, determined based on the safety and dose-escalation results from the Safety run-in phase.
의약품: GI-102

GI-102 will be administered in accordance with the procedures specified in the study protocol.

의약품: Pasritamig

Pasritamig will be administered in accordance with the procedures specified in the study protocol.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Incidence and nature of DLTs (Safety run-in phase)
기간: From Day -14 to Cycle 1 Day 22 (35 days)

A DLT is defined as a clinically significant AE (classified according to the NCI CTCAE version 6.0) or significant laboratory abnormality that occur during the DLT assessment periods, and is considered by the Investigator to be related to the study drug(s).
From Day -14 to Cycle 1 Day 22 (35 days)
Incidence, nature, and severity of AEs graded according to CTCAE v6.0 (Safety run-in phase)
기간: Up to 2 years

An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs. All AE events will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 6.0.
Up to 2 years
PSA response rate (≥ 50% decline from baseline) per PCWG3 (Expansion phase)
기간: Up to 2 years

PSA response rate is defined as the percentage of participants with a decline of PSA of 50% or more from baseline.
Up to 2 years

2차 결과 측정

결과 측정
측정값 설명
기간
PSA response rate (≥ 50% and ≥ 90% decline from baseline) per PCWG3 (Safety run-in phase)
기간: Up to 2 years

PSA response rate is defined as the percentage of participants with a decline of PSA of 50% (or 90%) or more from baseline.
Up to 2 years
Radiographic PFS per PCWG3
기간: Up to 2 years

Radiographic PFS is defined as the time from the date of first dose of any study treatment until the date of radiographic disease progression or death, whichever comes first.
Up to 2 years
Time to PSA progression
기간: Up to 2 years

Time to PSA progression, defined as the time from baseline to the first date of documented PSA progression per PCWG3 criteria.
Up to 2 years
Overall Response Rate (ORR) per RECIST v1.1
기간: Up to 2 years

Among participants with measurable disease, ORR is defined as the percentage of participants who achieve a partial response (PR) or complete response (CR) according to RECIST v1.1.
Up to 2 years
Duration of Response (DoR) per RECIST v1.1
기간: Up to 2 years

Among participants with measurable disease who achieve a CR or PR, DoR is defined as the time from the first documented CR or PR until the first documented disease progression according to RECIST v1.1 or death from any cause, whichever occurs first.
Up to 2 years
Disease Control Rate (DCR) per RECIST v1.1
기간: Up to 2 years

Among participants with measurable disease, DCR is defined as the percentage of participants who achieve a CR, PR, or stable disease (SD) according to RECIST v1.1.
Up to 2 years
Incidence, nature, and severity of AEs graded according to CTCAE v6.0 (Expansion phase)
기간: Up to 2 years

An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs. All AE events will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 6.0.
Up to 2 years
PK profile: peak plasma concentration (Cmax) of GI-102 when combined with pasritamig
기간: Up to 2 years

Plasma concentrations of GI-102 will be measured at specified time points following administration of GI-102 in combination with pasritamig to determine the maximum observed plasma concentration (Cmax).
Up to 2 years
PK profile: half-life (T1/2) of GI-102 when combined with pasritamig
기간: Up to 2 years

Plasma concentrations of GI-102 will be measured at specified time points following administration of GI-102 in combination with pasritamig to determine the terminal half-life (T1/2) of GI-102.
Up to 2 years
PK profile: area under the plasma concentration-time curve (AUC) of GI-102 when combined with pasritamig
기간: Up to 2 years

Plasma concentrations of GI-102 will be measured at specified time points following administration of GI-102 in combination with pasritamig to determine the area under the plasma concentration-time curve (AUC) of GI-102.
Up to 2 years

기타 결과 측정

결과 측정
측정값 설명
기간
Immune cell phenotyping in peripheral blood
기간: Up to 2 years

Immune cell populations and their changes following study treatment will be assessed in peripheral blood using flow cytometry.
Up to 2 years
Overall Response Rate (ORR) per iRECIST
기간: Up to 2 years

ORR is defined as the percentage of participants who achieve a partial response (PR) or complete response (CR) according to the iRECIST criteria.
Up to 2 years
Overall Survival (OS)
기간: Up to 2 years

Overall survival (OS) is defined as the time from the first dose of study treatment to death from any cause.
Up to 2 years
Incidence of anti-GI-102 antibody (ADA)
기간: Up to 2 years

Serum samples will be analyzed using a validated assay to determine the incidence of anti-GI-102 antibodies (ADA).
Up to 2 years
Incidence of Neutralizing Antibody (Nab) Against GI-102
기간: Up to 2 years

Serum samples that are positive for anti-GI-102 antibodies (ADA) will be further analyzed using a validated assay to determine the incidence of neutralizing antibodies (Nab).
Up to 2 years

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

GI Innovation, Inc.

협력자

Janssen Research & Development, LLC

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 (추정된)

2026년 10월 12일

기본 완료 (추정된)

2029년 3월 31일

연구 완료 (추정된)

2029년 9월 30일

연구 등록 날짜

최초 제출

2026년 10월 1일

QC 기준을 충족하는 최초 제출

2026년 10월 6일

처음 게시됨 (실제)

2026년 10월 13일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 9일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 4일

마지막으로 확인됨

2026년 11월 1일

추가 정보

이 연구와 관련된 용어

키워드

기타 연구 ID 번호

  • GII-102-P201 (JET-201)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

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