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A First-in-human Study of RLY-8161 in Advanced NRAS-Mutant Solid Tumors

2026년 6월 30일 업데이트: Relay Therapeutics, Inc.

A First-in-human Study of RLY-8161 for Treatment of Advanced NRAS-Mutant Melanoma and Other Solid Tumors

This is a Phase 1 first-in-human, open-label multicenter study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of RLY-8161, an NRAS-selective inhibitor, in participants with advanced NRAS-mutant melanoma and other solid tumors.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

This is a Phase 1 first-in-human, open-label multicenter study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of RLY-8161, an NRAS-selective inhibitor, in participants with advanced NRAS-mutant melanoma and other solid tumors. This study consists of 2 parts: dose escalation (Part 1) and dose expansion (Part 2).

Part 1, dose escalation will explore multiple ascending doses of RLY-8161 in participants with any advanced NRAS-mutant solid tumor until maximum tolerated dose is reached or one or more recommended Phase 2 dose (RP2D) is identified.

Part 2, dose expansion will be at the RP2D(s) identified in Part 1 in NRAS-mutant solid tumors.

연구 유형

중재적

등록 (추정된)

35

단계

  • 1단계

연락처 및 위치

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

연구 연락처

연구 장소

  • 미국
    • California
      • Los Angeles, California, 미국, 90095
        • 모병
        • University of California, Los Angeles
        • 연락하다:
      • San Francisco, California, 미국, 94143
    • Colorado
      • Aurora, Colorado, 미국, 80045
    • Massachusetts
      • Boston, Massachusetts, 미국, 02114
        • 모병
        • Massachusetts General Hospital
        • 연락하다:
      • Boston, Massachusetts, 미국, 02215
    • Michigan
      • Grand Rapids, Michigan, 미국, 49546
    • New York
      • New York, New York, 미국, 10065
        • 모병
        • Memorial Sloan Kettering Cancer Center
        • 연락하다:
    • Tennessee
      • Nashville, Tennessee, 미국, 37203
        • 모병
        • Sarah Cannon Research Institute Oncology Partners
        • 연락하다:
    • Virginia
      • Fairfax, Virginia, 미국, 22031

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

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
  • Histologically confirmed diagnosis of unresectable Stage III or IV melanoma or other solid tumor.
  • Disease is refractory to standard therapy (including targeted therapy), participant is intolerant of standard therapy, or participant has declined standard therapy.
  • Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
  • One or more documented primary oncogenic NRAS mutation(s).

Exclusion Criteria:

  • Known activating KRAS, HRAS, or BRAF mutation or known alterations in other driver oncogenes.
  • Prior treatment with ERK, MEK, RAF, or RAS targeting agents or any agent whose mechanism of action is to inhibit the RAS-MAPK pathway.
  • For participants with melanoma: lactate dehydrogenase (LDH) >2×ULN.
  • Central nervous system (CNS) metastases that are associated with progressive neurologic symptoms or require ongoing corticosteroids to control the CNS disease.

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: Part 1: RLY-8161 for participants with advanced NRAS-mutant solid tumors
Multiple doses of RLY-8161 for oral administration
의약품: RLY-8161
RLY-8161 is an NRAS-selective inhibitor
실험적: Part 2: RLY-8161 for participants with advanced NRAS-mutant solid tumors
Oral doses of RLY-8161 as determined during Part 1 Dose Escalation
의약품: RLY-8161
RLY-8161 is an NRAS-selective inhibitor

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
Part 1: Maximum Tolerated Dose (MTD) and/or RP2D of RLY-8161
기간: Cycle 1 (28-day cycle) of treatment for MTD and at the end of every cycle (28-day cycle) for RP2D until treatment discontinuation, approximately 12 months
Cycle 1 (28-day cycle) of treatment for MTD and at the end of every cycle (28-day cycle) for RP2D until treatment discontinuation, approximately 12 months
Part 1: Number of participants with Adverse Events (AEs) or Serious Adverse Events (SAEs), with changes in vital signs, electrocardiograms (ECGs), and laboratory tests
기간: Cycle 1 (28-day cycle) of treatment and at the end of every cycle (28-day cycle) until 30 days after treatment discontinuation, approximately 13 months
Cycle 1 (28-day cycle) of treatment and at the end of every cycle (28-day cycle) until 30 days after treatment discontinuation, approximately 13 months
Part 2: Objective Response Rate (ORR) of RLY-8161 as assessed by RECIST v1.1
기간: Approximately every 8 weeks on treatment and every 12 weeks after last dose in the absence of progressive disease, approximately 18 months
Approximately every 8 weeks on treatment and every 12 weeks after last dose in the absence of progressive disease, approximately 18 months

2차 결과 측정

결과 측정
기간
Part 1 and Part 2: Changes in NRAS mutant allele fraction in ctDNA
기간: Approximately every 2 weeks in Cycle 1 (28-day cycle), at the beginning of Cycle 2 (28-day cycle), and at the beginning of every odd cycle (28-day cycle) until End of Treatment (EOT), approximately 12 months
Approximately every 2 weeks in Cycle 1 (28-day cycle), at the beginning of Cycle 2 (28-day cycle), and at the beginning of every odd cycle (28-day cycle) until End of Treatment (EOT), approximately 12 months
Part 1 and Part 2: Plasma concentration and PK parameters of RLY-8161
기간: Approximately every 2 weeks in Cycle 1 (28-day cycle) and at Day 1 of every cycle (28-day cycle) through Cycle 4
Approximately every 2 weeks in Cycle 1 (28-day cycle) and at Day 1 of every cycle (28-day cycle) through Cycle 4
Part 1: ORR of RLY-8161 as assessed by RECIST v1.1
기간: Approximately every 8 weeks on treatment and every 12 weeks after last dose in the absence of progressive disease, approximately 18 months
Approximately every 8 weeks on treatment and every 12 weeks after last dose in the absence of progressive disease, approximately 18 months
Part 1 and 2: Duration of Response (DOR) of RLY-8161 as assessed by RECIST v1.1
기간: Approximately every 8 weeks on treatment and every 12 weeks after last dose in the absence of progressive disease, approximately 18 months
Approximately every 8 weeks on treatment and every 12 weeks after last dose in the absence of progressive disease, approximately 18 months
Part 1 and 2: Disease Control Rate (DCR) of RLY-8161 as assessed by RECIST v1.1
기간: Approximately every 8 weeks on treatment and every 12 weeks after last dose in the absence of progressive disease, approximately 18 months
Approximately every 8 weeks on treatment and every 12 weeks after last dose in the absence of progressive disease, approximately 18 months
Part 2: Progression-free survival (PFS) as assessed by RECIST v1.1
기간: Approximately every 8 weeks on treatment and every 12 weeks after last dose in the absence of progressive disease, approximately 18 months
Approximately every 8 weeks on treatment and every 12 weeks after last dose in the absence of progressive disease, approximately 18 months
Part 2: Overall Survival
기간: Cycle 1 (28-day cycles) until study completion, approximately 30 months
Cycle 1 (28-day cycles) until study completion, approximately 30 months
Part 2: Number of participants with AEs or SAEs, with changes in vital signs, ECGs, and laboratory tests
기간: Cycle 1 (28-day cycle) of treatment and at the end of every cycle (28-day cycle) until 30 days after treatment discontinuation, approximately 13 months
Cycle 1 (28-day cycle) of treatment and at the end of every cycle (28-day cycle) until 30 days after treatment discontinuation, approximately 13 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Relay Therapeutics, Inc.

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)

2026년 3월 9일

기본 완료 (추정된)

2027년 12월 30일

연구 완료 (추정된)

2029년 12월 31일

연구 등록 날짜

최초 제출

2026년 4월 28일

QC 기준을 충족하는 최초 제출

2026년 5월 6일

처음 게시됨 (실제)

2026년 5월 13일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 2일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 30일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • RLY-8161-101

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. .

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