Advanced Solid TumorPhase 1NCT07414836
A First-in-Human Study of BG-C0979 in Adults With Advanced Solid Tumors
A Phase 1 study testing BG-C0979 and Tislelizumab in people with Advanced Solid Tumor, run by BeOne Medicines at 18 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- BG-C0979 and Tislelizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 18 sitesin 4 countries
- Study dates
- 13 Apr 2026to 30 Apr 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
18 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
18 sites in 4 countries
China6 sites, 6 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
- Recruiting
Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)
Chongqing, Chongqing Municipality, 400037
- Recruiting
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, 350028
- Recruiting
Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)
Guangzhou, Guangdong, 510245
- Recruiting
Fudan University Shanghai Cancer Centerpudong
Shanghai, Shanghai Municipality, 201321
- Recruiting
Yichang Central Peoples Hospital
Yichang, Hubei, 443003
United States4 sites, 4 recruiting
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215-5418
- Recruiting
John Theurer Cancer Center Hackensack University Medical Center
Hackensack, New Jersey, 07601
- Recruiting
Next Oncology San Antonio
San Antonio, Texas, 78229
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110-1010
Australia4 sites, 4 recruiting
- Recruiting
Northern Beaches Hospital
Frenchs Forest, New South Wales, NSW 2086
- Recruiting
Liverpool Hospital
Liverpool, New South Wales, NSW 2170
- Recruiting
Cabrini Hospital Malvern
Malvern, Victoria, VIC 3144
- Recruiting
Icon Cancer Centre South Brisbane
South Brisbane, Queensland, QLD 4101
Spain4 sites, 4 recruiting
- Recruiting
Hospital Universitario Vall Dhebron
Barcelona, 08035
- Recruiting
Hospital Clinic de Barcelona
Barcelona, 08036
- Recruiting
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040
- Recruiting
Next Oncology Madrid
Madrid, 28223
About this study
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
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
- Being tested
- BG-C0979, Tislelizumab
- Keywords
- ADAM9 (disintegrin and metalloproteinase 9), antibody-drug conjugate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BG-C0979Drug
Administered by intravenous infusion.
TislelizumabDrug
Also called BGB-A317
Administered by intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1a: Monotherapy Dose Escalation | Experimental | Participants will receive increasing doses of BG-C0979 as monotherapy. Receives: 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. Receives: 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. Receives: Drug: BG-C0979 |
| Phase 1b, Part B: Combination Therapy Expansion | Experimental | Participants will receive BG-C0979 in combination with tislelizumab in select tumor types. Receives: Drug: BG-C0979; Drug: Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Up to approximately 24 months
Secondary outcomes (12)
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).
Measured: 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.
Measured: 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.
Measured: Up to approximately 24 months
Phase 1a: Plasma Concentration of BG-C0979
Measured: Up to approximately 3 months
Phase 1a: Area Under the Concentration-Time Curve (AUC) for BG-C0979
Measured: Up to approximately 3 months
Phase 1a: Maximum Observed Concentration (Cmax) of BG-C0979
Measured: Up to approximately 3 months
Phase 1a: Time to Maximum Concentration (Tmax) of BG-C0979
Measured: Up to approximately 3 months
Phase 1b: Number of Participants Experiencing Adverse Events (AEs)
Number of participants with TEAEs and SAEs, including AECIs, laboratory values, and electrocardiogram results.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to approximately 24 months
Phase 1b: Plasma Concentration of BG-C0979, Alone and in Combination with Tislelizumab
Measured: Up to approximately 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start13 Apr 2026
- Primary completion30 Apr 2029 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- More trials run by BeOne MedicinesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BeOne Medicines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, BeOne Medicines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07414836
- Sponsor's protocol ID
- BG-C0979-101
- Other IDs
- 2025-524857-15-00, CTR20261327, 2025
- Status last verified
- Sep 2026
- First submitted
- 11 Feb 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07414836
- Acronym / sponsor ID
- BG-C0979-101
- Conditions
- Advanced Solid Tumor
- Keywords
- ADAM9 (disintegrin and metalloproteinase 9), antibody-drug conjugate
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- BeOne MedicinesIndustry (pharma, biotech, devices)
- Study start
- 13 Apr 2026 (actual)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phase 1a: Monotherapy Dose Escalation | Experimental | Drug: BG-C0979Participants will receive increasing doses of BG-C0979 as monotherapy. |
| Phase 1a: Monotherapy Safety Expansion | Experimental | Drug: BG-C0979Participants 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. |
| Phase 1b, Part A: Monotherapy Dose Optimization and Dose Expansion | Experimental | Drug: BG-C0979Participants 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. |
| Phase 1b, Part B: Combination Therapy Expansion | Experimental | Drug: BG-C0979, Drug: TislelizumabParticipants will receive BG-C0979 in combination with tislelizumab in select tumor types. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BG-C0979Administered by intravenous infusion. | Drug | 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 |
| TislelizumabAlso: BGB-A317Administered by intravenous infusion. | Drug | Phase 1b, Part B: Combination Therapy Expansion |
Primary outcome
Phase 1a: Number of Participants Experiencing Adverse Events (AEs)
Time frame: 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
Time frame: 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])
Time frame: 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)
Time frame: 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)
Time frame: 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).
12 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Study Director study director
BeOne Medicines
18 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BG-C0979 and Tislelizumab in people with Advanced Solid Tumor, run by BeOne Medicines at 18 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in China, United States, Australia, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Director (8778285568, clinicaltrials@beonemed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1a: Number of Participants Experiencing Adverse Events (AEs) (time frame: Up to approximately 24 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.