- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07703878
A Study to Evaluate the Safety and Antitumor Activity of GS-1206 in Adults With Solid Tumors
A Phase 1 Study to Evaluate the Safety, Tolerability, and Antitumor Activity of GS-1206 in Adults With Solid Tumors
The goal of this clinical study is to learn more about the study drug GS-1206, including its safety, tolerability, and antitumor activity in adult participants with solid tumors.
연구 개요
연구 유형
등록 (추정된)
단계
- 1단계
연락처 및 위치
연구 연락처
- 이름: Gilead Clinical Study Information Center
- 전화번호: 1-833-445-3230 (GILEAD-0)
- 이메일: GileadClinicalTrials@gilead.com
연구 장소
-
-
Michigan
-
Grand Rapids, Michigan, 미국, 49546
- 모병
- START Midwest, LLC
-
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Texas
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Dallas, Texas, 미국, 75039
- 모병
- NEXT Oncology Dallas
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San Antonio, Texas, 미국, 78229
- 모병
- NEXT Oncology
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San Antonio, Texas, 미국, 78229
- 모병
- START San Antonio, LLC
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Key Inclusion Criteria:
- All individuals must have a tumor with protocol-specified mutation as determined by local health-authority approved test.
- For Part A (including backfill cohorts): Individuals with histologically confirmed advanced or metastatic solid tumors who have progressed following treatment in the advanced or metastatic setting known to confer clinical benefit, unless the individual refused, is intolerant to, or is not eligible for standard-of-care (SOC) treatment.
- For Part B dose expansion, individuals with protocol-specified tumor types will be enrolled.
Key Exclusion Criteria:
-
Use of any of the therapies listed below within the specified time frames:
- Investigational drugs (drugs not marketed for any indication) within 28 days prior to Cycle 1 Day 1.
- Anticancer biologic agent or immunotherapy within 28 days prior to Cycle 1 Day 1.
- Anticancer chemotherapy or targeted approved small molecule therapy within 21 days prior to Cycle 1 Day 1, or 42 days for nitrosoureas or mitomycin.
- Hormonal or other adjunctive therapy for cancers other than the cancer under evaluation in this study that started within 14 days prior to planned Cycle 1 Day 1 are not permitted. Exceptions: hormonal therapy, bisphosphonates, somatostatin analogues, and leuprolide are permitted if started at least 14 days prior to Cycle 1 Day 1.
- Major surgery (excluding minor procedures, eg, placement of vascular access, gastrointestinal/biliary stent, biopsy) within 28 days prior to Cycle 1 Day 1, and any toxicity or complications have recovered to Grade 1 or less.
- Radiation therapy within 21 days prior to Cycle 1 Day 1. Exception: limited (eg, pain palliation) radiation therapy is allowed if any radiation associated toxicity is resolved to Grade 1 or less, and the radiation is not administered to a target lesion.
Note: Other protocol defined Inclusion/Exclusion criteria may 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: Part A: Dose Escalation
Participants will receive escalating doses of GS-1206 monotherapy one time daily up to 35 cycles. |
Administered Orally |
|
실험적: Part B: Dose Expansion
Participants will be enrolled in different indication specific cohorts. Participants will receive GS-1206 monotherapy at the recommended dose one time daily up to 35 cycles. |
Administered Orally |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Percentage of Participants Experiencing any Dose-limiting Toxicities (DLTs)
기간: First dose up to 21 days post first dose
|
First dose up to 21 days post first dose
|
|
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAE) Based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v6.0.
기간: First dose date up to 30 days post last dose (Up to 3 years)
|
First dose date up to 30 days post last dose (Up to 3 years)
|
|
Percentage of Participants Experiencing Clinical Laboratory Abnormalities Based National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v6.0.
기간: First dose date up to 30 days post last dose (Up to 3 years)
|
First dose date up to 30 days post last dose (Up to 3 years)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Plasma Concentrations of GS-1206 and its Metabolites After Single Dose and Repeated Dose Administration
기간: Predose and postdose up to end of treatment (up to 2 years)
|
Predose and postdose up to end of treatment (up to 2 years)
|
|
|
Pharmacokinetic (PK) Parameter: Cmax of GS-1206 and its Metabolites
기간: Up to 2 years
|
Cmax is defined as the maximum observed concentration of drug |
Up to 2 years
|
|
PK Parameter: Tmax of GS-1206 and its Metabolites
기간: Up to 2 years
|
Tmax is defined as the time (observed time point) of Cmax |
Up to 2 years
|
|
PK Parameter: AUC0-24h of GS-1206 and its Metabolites
기간: Up to 2 years
|
AUC0-24h is defined as the partial area under the concentration versus time curve from time 0 to time 24 |
Up to 2 years
|
|
Objective Response Rate (ORR)
기간: Up to 3 years
|
ORR is defined as the percentage of participants who have measurable disease at baseline and have achieved complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and assessed by the investigator at the local site. |
Up to 3 years
|
|
Duration of Response (DOR)
기간: Up to 3 years
|
DOR is defined as the measurement from the time of first response (CR or PR) as assessed by the investigator at local site, per RECIST v1.1 until the date of first documented disease progression or death, whichever occurs first. |
Up to 3 years
|
|
Best Overall Response (BOR)
기간: Up to 3 years
|
BOR is defined as the best response recorded from first dosing date until disease progression identified by RECIST v1.1, death, or the participant discontinues study treatment, whichever occurs first. |
Up to 3 years
|
|
Progression-Free Survival (PFS)
기간: Up to 3 years
|
PFS is defined as the time from first dosing date until disease progression or death from any cause, whichever comes first as measured per RECIST v1.1. |
Up to 3 years
|
|
Disease Control Rate (DCR)
기간: Up to 3 years
|
DCR is defined as the measurement by the percentage of participants who achieve confirmed response of CR or PR or stable disease. |
Up to 3 years
|
공동 작업자 및 조사자
스폰서
수사관
- 연구 책임자: Gilead Study Director, Gilead Sciences
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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
기타 연구 ID 번호
- GS-US-723-7652
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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