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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: BG-C0979; Drug: Tislelizumab

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Study Director; Phone Number: 8778285568; Email: clinicaltrials@beonemed.com

Study Locations

• Australia
  • New South Wales
    • Frenchs Forest, New South Wales, Australia, NSW 2086
      • Recruiting
      • Northern Beaches Hospital
  • Queensland
    • South Brisbane, Queensland, Australia, QLD 4101
      • Recruiting
      • Icon Cancer Centre South Brisbane
  • Victoria
    • Malvern, Victoria, Australia, VIC 3144
      • Recruiting
      • Cabrini Hospital Malvern
• China
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 400037
      • Recruiting
      • Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)
• Spain
  • Barcelona, Spain, 08036
    • Recruiting
    • Hospital Clinic De Barcelona
  • Madrid, Spain, 28040
    • Recruiting
    • Hospital Universitario Fundacion Jimenez Diaz
  • Madrid, Spain, 28223
    • Recruiting
    • NEXT Oncology Madrid
• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • Next Oncology San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase 1a: Monotherapy Dose Escalation; Participants will receive increasing doses of BG-C0979 as monotherapy.	Drug: BG-C0979; Administered by intravenous infusion.
Experimental: 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.	Drug: BG-C0979; Administered by intravenous infusion.
Experimental: 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.	Drug: BG-C0979; Administered by intravenous infusion.
Experimental: Phase 1b, Part B: Combination Therapy Expansion; Participants will receive BG-C0979 in combination with tislelizumab in select tumor types.	Drug: BG-C0979; Administered by intravenous infusion.; Drug: Tislelizumab; Administered by intravenous infusion.; Other Names: BGB-A317

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 1a: ORR	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)	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)	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 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
Phase 1a: Maximum Observed Concentration (Cmax) of BG-C0979		Up to approximately 3 months
Phase 1a: Time to Maximum Concentration (Tmax) of BG-C0979		Up to approximately 3 months
Phase 1a and 1b: Number of Participants with Anti-Drug Antibodies (ADAs)		Up to approximately 24 months
Phase 1b: Number of Participants Experiencing Adverse Events (AEs)	Number of participants with TEAEs and SAEs, including AECIs, laboratory values, and electrocardiogram results.	Up to approximately 24 months
Phase 1b: Progression-Free Survival	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	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	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
Phase 1b: Plasma Concentration of BG-C0979, Alone and in Combination with Tislelizumab		Up to approximately 3 months

Collaborators and Investigators

• Sponsor: BeOne Medicines
• Investigators: Study Director: Study Director, BeOne Medicines

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2026
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): April 30, 2029

Study Registration Dates

• First Submitted: February 11, 2026
• First Submitted That Met QC Criteria: February 11, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: antibody-drug conjugate; ADAM9 (disintegrin and metalloproteinase 9)
• Additional Relevant MeSH Terms: tislelizumab
• Other Study ID Numbers: BG-C0979-101; 2025-524857-15-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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 Sharing Time Frame: See plan description
• IPD Sharing Access Criteria: See plan description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No