Recruiting NCT07414836
A First-in-Human Study of BG-C0979 in Adults With Advanced Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BG-C0979, Tislelizumab.
- Who it may be relevant to
- Registry conditions: Advanced Solid Tumor. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, China, Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter, Open-Label, Phase 1a/b First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of BG-C0979 in Patients With Selected Advanced Solid Tumors
Overview
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).
Interventions
- Drug BG-C0979
Administered by intravenous infusion. - Drug Tislelizumab
Administered by intravenous infusion.
Primary outcome measures
- Phase 1a: Number of Participants Experiencing Adverse Events (AEs) [Time frame: Up to approximately 24 months]
- Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-C0979 Monotherapy [Time frame: Up to approximately 10 months]
- Phase 1a: Recommended Dose(s) for Expansion (RDFE[s]) [Time frame: Up to approximately 10 months]
- Phase 1b: Recommended Phase 2 Dose (RP2D) [Time frame: Up to approximately 24 months]
- Phase 1b: Overall Response Rate (ORR) [Time frame: Up to approximately 24 months]
Secondary outcome measures (12)
- Phase 1a: ORR [Time frame: Up to approximately 24 months]
- Phase 1a and 1b: Duration of Response (DOR) [Time frame: Up to approximately 24 months]
- Phase 1a and 1b: Disease Control Rate (DCR) [Time frame: Up to approximately 24 months]
- Phase 1a: Plasma Concentration of BG-C0979 [Time frame: Up to approximately 3 months]
- Phase 1a: Area Under the Concentration-Time Curve (AUC) for BG-C0979 [Time frame: Up to approximately 3 months]
- Phase 1a: Maximum Observed Concentration (Cmax) of BG-C0979 [Time frame: Up to approximately 3 months]
- Phase 1a: Time to Maximum Concentration (Tmax) of BG-C0979 [Time frame: Up to approximately 3 months]
- Phase 1b: Number of Participants Experiencing Adverse Events (AEs) [Time frame: Up to approximately 24 months]
- Phase 1b: Progression-Free Survival [Time frame: Up to approximately 24 months]
- Phase 1b: Radiographic Progression-Free Survival (rPFS) for Participants with CRPC [Time frame: Up to approximately 24 months]
- Prostate-Specific Antigen (PSA) Response for Participants with CRPC [Time frame: Up to approximately 24 months]
- Phase 1b: Plasma Concentration of BG-C0979, Alone and in Combination with Tislelizumab [Time frame: Up to approximately 3 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 6 centers
- Cancer Hospital Chinese Academy of Medical Sciences — Beijing
- Second Affiliated Hospital of Army Medical University (Xinqiao Hospital) — Chongqing
- Mengchao Hepatobiliary Hospital of Fujian Medical University — Fuzhou
- Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South) — Guangzhou
- Yichang Central Peoples Hospital — Yichang
- Fudan University Shanghai Cancer Centerpudong — Shanghai
Australia · 4 centers
- Northern Beaches Hospital — Frenchs Forest
- Liverpool Hospital — Liverpool
- Icon Cancer Centre South Brisbane — South Brisbane
- Cabrini Hospital Malvern — Malvern
Spain · 4 centers
- Hospital Universitario Vall Dhebron — Barcelona
- Hospital Clinic de Barcelona — Barcelona
- Hospital Universitario Fundacion Jimenez Diaz — Madrid
- Next Oncology Madrid — Madrid
United States · 3 centers
- Washington University School of Medicine — St Louis
- John Theurer Cancer Center Hackensack University Medical Center — Hackensack
- Next Oncology San Antonio — San Antonio
Identifiers
NCT: NCT07414836 · BG-C0979-101 · 2025-524857-15-00 · CTR20261327