진행성 고형 종양을 가진 성인을 대상으로 한 BG-C0979의 첫 번째 인체 연구
선정된 진행성 고형암 환자에서 BG-C0979의 안전성, 내약성, 약동학 및 예비 항종양 활성을 조사하기 위한 다기관, 개방형, 1a/b상 최초 인체 대상 연구
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of BG-C0979 monotherapy or in combination with tislelizumab in participants with selected advanced solid tumors. The study will consist of Phase 1a (Dose Escalation and Safety Expansion) and Phase 1b (Dose Expansion).
연구 개요
연구 유형
등록 (추정된)
단계
- 1단계
연락처 및 위치
연구 연락처
- 이름: Study Director
- 전화번호: 8778285568
- 이메일: clinicaltrials@beonemed.com
연구 장소
-
-
Massachusetts
-
Boston, Massachusetts, 미국, 02215-5418
- 모병
- Dana Farber Cancer Institute
-
-
Missouri
-
St Louis, Missouri, 미국, 63110-1010
- 모병
- Washington University School of Medicine
-
-
New Jersey
-
Hackensack, New Jersey, 미국, 07601
- 모병
- John Theurer Cancer Center Hackensack University Medical Center
-
-
Texas
-
San Antonio, Texas, 미국, 78229
- 모병
- Next Oncology San Antonio
-
-
-
-
-
Barcelona, 스페인, 08036
- 모병
- Hospital Clinic de Barcelona
-
Barcelona, 스페인, 08035
- 모병
- Hospital Universitario Vall Dhebron
-
Madrid, 스페인, 28040
- 모병
- Hospital Universitario Fundacion Jimenez Diaz
-
Madrid, 스페인, 28223
- 모병
- Next Oncology Madrid
-
-
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, 중국, 100021
- 모병
- Cancer Hospital Chinese Academy of Medical Sciences
-
-
Chongqing Municipality
-
Chongqing, Chongqing Municipality, 중국, 400037
- 모병
- Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)
-
-
Fujian
-
Fuzhou, Fujian, 중국, 350028
- 모병
- Mengchao Hepatobiliary Hospital of Fujian Medical University
-
-
Guangdong
-
Guangzhou, Guangdong, 중국, 510245
- 모병
- Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)
-
-
Hubei
-
Yichang, Hubei, 중국, 443003
- 모병
- Yichang Central Peoples Hospital
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, 중국, 201321
- 모병
- Fudan University Shanghai Cancer Centerpudong
-
-
-
-
New South Wales
-
Frenchs Forest, New South Wales, 호주, NSW 2086
- 모병
- Northern Beaches Hospital
-
Liverpool, New South Wales, 호주, NSW 2170
- 모병
- Liverpool Hospital
-
-
Queensland
-
South Brisbane, Queensland, 호주, QLD 4101
- 모병
- Icon Cancer Centre South Brisbane
-
-
Victoria
-
Malvern, Victoria, 호주, VIC 3144
- 모병
- Cabrini Hospital Malvern
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Phase 1a (Monotherapy Dose Escalation and Safety Expansion): Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have previously received standard systemic therapy or for whom treatment is not available or not tolerated, or determined not appropriate based on investigator's judgment.
- Phase 1b Part A (Monotherapy Dose Optimization and Expansion): Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have previously received standard systemic therapy or for whom treatment is not available or not tolerated, or determined not appropriate based on investigator's judgment.
- Phase 1b Part B (Combination Therapy Expansion): Participants with histologically or cytologically confirmed metastatic or unresectable advanced solid tumors who have not received any prior systemic treatment for advanced or metastatic disease.
- Participants must have ≥ 1 measurable lesion as assessed by RECIST v1.1.
- Participants must have a stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Participants must have adequate organ function.
Exclusion Criteria:
- Prior treatment with any ADAM9 (a disintegrin and metalloproteinase domain 9)-targeted antibody-drug conjugates (ADCs) or ADCs containing TOPO1 (DNA topoisomerase 1) inhibitor as payload.
- Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
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: Phase 1a: Monotherapy Dose Escalation
Participants will receive increasing doses of BG-C0979 as monotherapy. |
Administered by intravenous infusion. |
|
실험적: Phase 1a: Monotherapy Safety Expansion
Participants will receive BG-C0979 as monotherapy. Selected dose levels that have been determined to be safe in Phase 1a dose escalation will be further evaluated in safety expansion. |
Administered by intravenous infusion. |
|
실험적: Phase 1b, Part A: Monotherapy Dose Optimization and Dose Expansion
Participants will receive BG-C0979 as monotherapy in a dose optimization and dose expansion phase at different dose levels of recommended doses for expansion (RDFEs) identified in Phase 1a. |
Administered by intravenous infusion. |
|
실험적: Phase 1b, Part B: Combination Therapy Expansion
Participants will receive BG-C0979 in combination with tislelizumab in select tumor types. |
Administered by intravenous infusion. Administered by intravenous infusion.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Phase 1a: Number of Participants Experiencing Adverse Events (AEs)
기간: Up to approximately 24 months
|
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including dose limiting toxicities (DLTs), AEs meeting protocol-defined adverse event of clinical interest (AECI) criteria, laboratory values, and electrocardiogram results. |
Up to approximately 24 months
|
|
Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-C0979 Monotherapy
기간: Up to approximately 10 months
|
MTD or MAD, defined as the highest dose for which the estimated toxicity rate is closest to the target toxicity rate of 28%, or the highest dose administered, respectively. |
Up to approximately 10 months
|
|
Phase 1a: Recommended Dose(s) for Expansion (RDFE[s])
기간: Up to approximately 10 months
|
The potential RDFE(s) of BG-C0979 will be determined based on the totality of data including the MTD or MAD, long-term tolerability, pharmacokinetics (PK), preliminary antitumor activity, and any other relevant data, as available. |
Up to approximately 10 months
|
|
Phase 1b: Recommended Phase 2 Dose (RP2D)
기간: Up to approximately 24 months
|
RP2D of BG-C0979 alone and in combination with tislelizumab will be determined based on safety, PK, preliminary antitumor activity, and other relevant data, as available. |
Up to approximately 24 months
|
|
Phase 1b: Overall Response Rate (ORR)
기간: Up to approximately 24 months
|
ORR as determined from tumor assessment by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. For castration-resistant prostate cancer (CRPC), ORR will be assessed by RECIST v1.1 criteria for soft tissue and Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria for bone lesions. ORR is defined as the percentage of participants with best overall response of a complete response (CR) or partial response (PR). |
Up to approximately 24 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Phase 1a: BG-C0979의 혈장 농도
기간: 최대 약 3개월
|
최대 약 3개월
|
|
|
1a상: BG-C0979의 농도-시간 곡선 아래 면적(AUC)
기간: 최대 약 3개월
|
최대 약 3개월
|
|
|
1a상: BG-C0979의 최대 관찰 농도(Cmax)
기간: 약 3개월까지
|
약 3개월까지
|
|
|
Phase 1a: BG-C0979의 최대 농도 도달 시간(Tmax)
기간: 최대 약 3개월
|
최대 약 3개월
|
|
|
1b상: BG-C0979 단독 및 Tislelizumab과 병용 시 혈장 내 농도
기간: 최대 약 3개월
|
최대 약 3개월
|
|
|
Phase 1a: ORR
기간: Up to approximately 24 months
|
ORR as determined from tumor assessment by the investigator using RECIST v1.1. For CRPC, ORR will be assessed by RECIST v1.1 criteria for soft tissue and PCWG3 criteria for bone lesions. ORR is defined as the percentage of participants with best overall response of a complete response (CR) or partial response (PR). |
Up to approximately 24 months
|
|
Phase 1a and 1b: Duration of Response (DOR)
기간: Up to approximately 24 months
|
DOR as determined from tumor assessment by the investigator using RECIST v1.1. For CRPC, DOR will be assessed by RECIST v1.1 criteria for soft tissue and PCWG3 criteria for bone lesions. DOR is defined as the time from the first determination of an objective response until the first documentation of disease progression or death due to any cause, whichever occurs first. |
Up to approximately 24 months
|
|
Phase 1a and 1b: Disease Control Rate (DCR)
기간: Up to approximately 24 months
|
DCR as determined from tumor assessment by the investigator using RECIST v1.1. For CRPC, DCR will be assessed by RECIST v1.1 criteria for soft tissue and PCWG3 criteria for bone lesions. DCR is defined as the percentage of participants with best overall response of a CR, PR, or stable disease. |
Up to approximately 24 months
|
|
Phase 1b: Number of Participants Experiencing Adverse Events (AEs)
기간: Up to approximately 24 months
|
Number of participants with TEAEs and SAEs, including AECIs, laboratory values, and electrocardiogram results. |
Up to approximately 24 months
|
|
Phase 1b: Progression-Free Survival
기간: Up to approximately 24 months
|
PFS is defined as the time from the date of the first administration of study drug(s) to the date of the first documentation of disease progression or death due to any cause, whichever occurs first. |
Up to approximately 24 months
|
|
Phase 1b: Radiographic Progression-Free Survival (rPFS) for Participants with CRPC
기간: Up to approximately 24 months
|
rPFS is defined as the time from the date of the first administration of study drug(s) to the date of the first objective evidence of radiographic disease progression or death due to any cause, whichever occurs first. |
Up to approximately 24 months
|
|
Prostate-Specific Antigen (PSA) Response for Participants with CRPC
기간: Up to approximately 24 months
|
PSA response is defined as a ≥50% decrease in PSA level from baseline to the lowest post-baseline PSA result, confirmed by a second consecutive PSA assessment at least 3 weeks later. |
Up to approximately 24 months
|
공동 작업자 및 조사자
스폰서
수사관
- 연구 책임자: Study Director, BeOne Medicines
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- BG-C0979-101
- 2025-524857-15-00 (씨티스)
- CTR20261327 (기타 식별자: ChinaDrugTrials)
- 2025 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.
BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.
Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
IPD 공유 기간
See plan description
IPD 공유 액세스 기준
See plan description
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .