진행성, 전이성 및 진행성 대장 암 환자의 RBS2418 평가 (VISTA-1)
RBS2418에 대한 무작위, 이중 맹검, 위약 대조, 2A 단계 2A 연구, 고급, 전이성 및 진보적 인 결장 직장암이있는 대상에서 BSC (Best Supportive Care).
RBS2418 is a specific immune modulator that works through the inhibition of ectonucleotide pyrophosphatase/phosphodiesterase 1 (ENPP1) and is designed to lead to anti-tumor immunity by protecting endogenous 2'-3'-cyclic guanosine monophosphate-adenosine monophosphate (cGAMP) from hydrolysis and leading to the activation of antigen-presenting cells followed by T cell activation. The hypothesis is that RBS2418 versus placebo will be generally safe, well-tolerated, immunogenic, and will lead to anti-tumor responses in adult subjects for the treatment of advanced, metastatic, and progressive colorectal cancer (CRC).
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
In this Phase 2a study, subjects must have failed, been unable to tolerate, or declined to take known standard-of-care (SOC) therapies. Subjects must have measurable disease per RECIST 1.1, an Eastern Cooperative Oncology Group (ECOG) performance score of 0, 1 or 2, and predicted life expectancy of greater or equal to 3 months.
Up to approximately 150 subjects will be enrolled and will receive therapy as part of their respective treatment group. Subjects will receive study treatment of RBS2418 or Placebo to Match plus Best Supportive Care with a treatment period consisting of 21-day cycles up to two years or until there is progressive disease (PD), death, withdrawal, or study completion, whichever comes first.
Adverse events (AEs) will be monitored throughout the study and graded in severity according to the guidelines outlined in the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0. AEs will be collected until up to 30 days after the end of treatment or until resolution, whichever comes first. Serious Adverse Events (SAEs) will be collected for 90 days after the end of treatment, or if the subject initiates new anti-cancer therapy, then 30 days after the end of treatment, whichever is earlier.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 2 단계
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Riboscience Clinical Trials
- 전화번호: (415) 754-3182
- 이메일: clinicaltrials@riboscience.com
연구 장소
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Delaware
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Newark, Delaware, 미국, 19718
- 모병
- Christiana Care
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Nevada
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Las Vegas, Nevada, 미국, 89169
- 모병
- Comprehensive Cancer Centers of Nevada
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Tennessee
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Nashville, Tennessee, 미국, 37203
- 모병
- SCRI Oncology LLC
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Texas
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Kingwood, Texas, 미국, 77339
- 모병
- Community Clinical Trials
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Ho Chi Minh City, 베트남, 715000
- 모병
- Oncology Hospital
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Hanoi
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Hanoi, Hanoi, 베트남, 10000
- 모병
- Tam Anh, Ha Noi General Hospital
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Ho Chi Minh City
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Ho Chi Minh City, Ho Chi Minh City, 베트남, 70000
- 모병
- Tam Anh TP. Ho Chi Minh General Hospital
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San Juan, 푸에르토 리코, 00935
- 모병
- Pan Oncology
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- At least 18 years of age on the day of signing informed consent.
- Male and female subjects with advanced, metastatic, progressive CRC who have received, been ineligible for, intolerant to, or declined all approved standard of care (SOC) therapies for metastatic CRC, as per local SOC treatment regimens. Additionally, subjects must have documented PD based on two scans performed within 2 to 4 months of study initiation.
- Have histologically or cytologically confirmed CRC diagnosis based on pathology report.
- Willing to submit a pre-treatment tissue sample (archival, or fresh tissue if archival is not available).
Exclusion Criteria:
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Any approved anti-cancer therapy including chemotherapy, targeted small molecule therapy, systemic immunotherapy, or radiation therapy within 2 weeks prior to the first dose of study treatment; or if subject has not recovered (i.e., ≤ to Grade 1 or returned to baseline level) from AEs due to a previously administered agent; the following exceptions are allowed:
- Palliative radiotherapy for bone metastases or soft tissue lesions should be completed >7 days prior to the first dose of study treatment.
- Hormone-replacement therapy or oral contraceptives.
- Subjects with Grade 2 neuropathy or Grade 2 alopecia.
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Subjects with evidence of rapid progression on prior therapy resulting in rapid clinical deterioration.
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Malignancies other than indications open for enrollment within 3 years prior to Day 1, except for those with negligible risk of metastasis or death treated with expected curative outcome, undergoing active surveillance, or treatment-naïve for indolent tumors.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
활성 비교기: Group A: EG+ [ENPP1 and cGAS(Cyclic GMP-AMP synthase) positive] RBS2418 plus Best Supportive Care
RBS2418: 200 mg (2 RBS2418 capsules), PO (by mouth), BID (twice a day) plus Best Supportive Care |
RBS2418 is a specific immune modulator that works through the inhibition of ectonucleotide pyrophosphatase/phosphodiesterase 1 (ENPP1) and is designed to lead to anti-tumor immunity by protecting endogenous 2'-3'-cyclic guanosine monophosphate-adenosine monophosphate (cGAMP) from hydrolysis and leading to the activation of antigen-presenting cells followed by T cell activation. |
|
위약 비교기: Group B: EG+ (ENPP1 and cGAS positive) Placebo plus Best Supportive Care
Placebo: 2 placebo capsules, PO, BID plus Best Supportive Care |
Placebo to Match RBS2418 |
|
활성 비교기: Group C: EG- (ENPP1 and/or cGAS negative) RBS2418 plus Best Supportive Care
RBS2418: 200 mg (2 RBS2418 capsules), PO, BID plus Best Supportive Care |
RBS2418 is a specific immune modulator that works through the inhibition of ectonucleotide pyrophosphatase/phosphodiesterase 1 (ENPP1) and is designed to lead to anti-tumor immunity by protecting endogenous 2'-3'-cyclic guanosine monophosphate-adenosine monophosphate (cGAMP) from hydrolysis and leading to the activation of antigen-presenting cells followed by T cell activation. |
|
위약 비교기: Group D: EG- (ENPP1 and/or cGAS negative) Placebo plus Best Supportive Care
Placebo: 2 placebo capsules, PO, BID plus Best Supportive Care |
Placebo to Match RBS2418 |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Progression Free Survival
기간: From randomization until the first radiographic documentation of objective progression or death from any cause, assessed up to 2 years.
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Time in months from randomization until the first radiographic documentation of objective progression, as assessed using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, or death from any cause |
From randomization until the first radiographic documentation of objective progression or death from any cause, assessed up to 2 years.
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Overall Survival
기간: From randomization until death from any cause, assessed up to 2 years.
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Time in months from the date of randomization to the date of death from any cause |
From randomization until death from any cause, assessed up to 2 years.
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Duration of Response (DOR)
기간: From initial response to disease progression or death, assessed up to 2 years.
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DOR is defined as the time in months from initial response [when complete response (CR) or partial response (PR) is first determined] to disease progression or death, whichever comes first. |
From initial response to disease progression or death, assessed up to 2 years.
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Disease Control Rate (DCR)
기간: From randomization to end of treatment or disease progression, assessed up to 2 years.
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DCR is defined as the percentage of subjects who achieve a complete response (CR), a partial response (PR) or stable disease (SD). |
From randomization to end of treatment or disease progression, assessed up to 2 years.
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공동 작업자 및 조사자
협력자
협력자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- RBS2418-2001
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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