A First-in-Human Study of BG-C0979 in Adults With Advanced Solid Tumors

NCT07414836 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: BG-C0979-1012025-524857-15-00
• Study Type: interventional
• Target: 84
• Locations: 3 countries
• Sites: 4

Brief 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).

Conditions

Advanced Solid Tumor

Keywords

ADAM9 (disintegrin and metalloproteinase 9); antibody-drug conjugate

Outcome Measures

Primary Outcomes (5)

• Phase 1a: Number of Participants Experiencing Adverse Events (AEs)

  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

  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])

  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)

  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)

  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

Secondary Outcomes (13)

• Phase 1a: ORR

  Up to approximately 24 months

• Phase 1a and 1b: Duration of Response (DOR)

  Up to approximately 24 months

• Phase 1a and 1b: Disease Control Rate (DCR)

  Up to approximately 24 months

• Phase 1a: Plasma Concentration of BG-C0979

  Up to approximately 3 months

• Phase 1a: Area Under the Concentration-Time Curve (AUC) for BG-C0979

  Up to approximately 3 months

Study Arms (4)

Phase 1a: Monotherapy Dose Escalation

EXPERIMENTAL

Participants will receive increasing doses of BG-C0979 as monotherapy.

Drug: BG-C0979

Phase 1a: Monotherapy Safety Expansion

EXPERIMENTAL

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.

Drug: BG-C0979

Phase 1b, Part A: Monotherapy Dose Optimization and Dose Expansion

EXPERIMENTAL

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.

Drug: BG-C0979

Phase 1b, Part B: Combination Therapy Expansion

EXPERIMENTAL

Participants will receive BG-C0979 in combination with tislelizumab in select tumor types.

Drug: BG-C0979; Drug: Tislelizumab

Interventions

BG-C0979 DRUG

Administered by intravenous infusion.

Phase 1a: Monotherapy Dose Escalation; Phase 1a: Monotherapy Safety Expansion; Phase 1b, Part A: Monotherapy Dose Optimization and Dose Expansion; Phase 1b, Part B: Combination Therapy Expansion

Tislelizumab DRUG

Administered by intravenous infusion.

Also known as: BGB-A317

Phase 1b, Part B: Combination Therapy Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Prior treatment with any ADAM9-targeted antibody-drug conjugates (ADCs) or ADCs containing TOPO1 inhibitor as payload.
• Active leptomeningeal disease or uncontrolled, untreated brain metastasis.

Sponsors & Collaborators

• BeOne Medicines: lead

Study Sites (4)

Next Oncology San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

Northern Beaches Hospital

Frenchs Forest, New South Wales, NSW 2086, Australia

RECRUITING

Icon Cancer Centre South Brisbane

South Brisbane, Queensland, QLD 4101, Australia

RECRUITING

Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)

Chongqing, Chongqing Municipality, 400037, China

RECRUITING

MeSH Terms

Interventions

tislelizumab

Study Officials

• Study Director

  BeOne Medicines

  STUDY DIRECTOR

Central Study Contacts

Study Director

CONTACT

8778285568; clinicaltrials@beonemed.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: February 17, 2026
• Study Start: April 13, 2026
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): April 30, 2029
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See plan description
• Access Criteria: See plan description

Locations

US (1); AU (2); CN (1)