Clinical Trials in Australia / NCT07414836
Recruiting
Phase 1
A First-in-Human Study of BG-C0979 in Adults With Advanced Solid Tumors
NCT07414836 · tracked via the Priya Life Science Australia tracker
Condition(s) studied
Advanced Solid Tumor
Investigational drug(s) / intervention(s)
BG-C0979Tislelizumab →
BG-C0979: Administered by intravenous infusion.
Tislelizumab: Administered by intravenous infusion.
Study summary
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).
Eligibility
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.
Primary outcome measure(s)
- Phase 1a: Number of Participants Experiencing Adverse Events (AEs) — 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. - Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-C0979 Monotherapy — 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. - Phase 1a: Recommended Dose(s) for Expansion (RDFE[s]) — 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. - Phase 1b: Recommended Phase 2 Dose (RP2D) — 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. - Phase 1b: Overall Response Rate (ORR) — 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).
Trial sites (18)
| Facility | City | Region | Status |
|---|---|---|---|
| Dana Farber Cancer Institute | Boston | Massachusetts | Recruiting |
| Washington University School of Medicine | St Louis | Missouri | Recruiting |
| John Theurer Cancer Center Hackensack University Medical Center | Hackensack | New Jersey | Recruiting |
| Next Oncology San Antonio | San Antonio | Texas | Recruiting |
| Northern Beaches Hospital | Frenchs Forest | New South Wales | Recruiting |
| Liverpool Hospital | Liverpool | New South Wales | Recruiting |
| Icon Cancer Centre South Brisbane | South Brisbane | Queensland | Recruiting |
| Cabrini Hospital Malvern | Malvern | Victoria | Recruiting |
| Cancer Hospital Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | Recruiting |
| Second Affiliated Hospital of Army Medical University (Xinqiao Hospital) | Chongqing | Chongqing Municipality | Recruiting |
| Mengchao Hepatobiliary Hospital of Fujian Medical University | Fuzhou | Fujian | Recruiting |
| Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South) | Guangzhou | Guangdong | Recruiting |
| Yichang Central Peoples Hospital | Yichang | Hubei | Recruiting |
| Fudan University Shanghai Cancer Centerpudong | Shanghai | Shanghai Municipality | Recruiting |
| Hospital Universitario Vall Dhebron | Barcelona | Spain | Recruiting |
| Hospital Clinic de Barcelona | Barcelona | Spain | Recruiting |
| Hospital Universitario Fundacion Jimenez Diaz | Madrid | Spain | Recruiting |
| Next Oncology Madrid | Madrid | Spain | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07414836 on ClinicalTrials.gov ↗ ← All trials in Australia