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NCT07414836From ClinicalTrials.govRecruiting

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

  • Advanced Solid Tumor

At a glance

Phase
Phase 1
Study type
Interventional
Sponsor
BeOne Medicines
Enrolment target
84
Started
13 April 2026
Main results due
30 April 2029
Study sites
18
Registry updated
28 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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.

What this study is about

In the sponsor’s own words, from the registry.

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 sites(18)

  • Dana Farber Cancer Institute

    Boston, Massachusetts, United States

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouri, United States

    Recruiting

  • John Theurer Cancer Center Hackensack University Medical Center

    Hackensack, New Jersey, United States

    Recruiting

  • Next Oncology San Antonio

    San Antonio, Texas, United States

    Recruiting

  • Northern Beaches Hospital

    Frenchs Forest, New South Wales, Australia

    Recruiting

  • Liverpool Hospital

    Liverpool, New South Wales, Australia

    Recruiting

  • Icon Cancer Centre South Brisbane

    South Brisbane, Queensland, Australia

    Recruiting

  • Cabrini Hospital Malvern

    Malvern, Victoria, Australia

    Recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, China

    Recruiting

  • Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)

    Chongqing, Chongqing Municipality, China

    Recruiting

  • Mengchao Hepatobiliary Hospital of Fujian Medical University

    Fuzhou, Fujian, China

    Recruiting

  • Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)

    Guangzhou, Guangdong, China

    Recruiting

  • Yichang Central Peoples Hospital

    Yichang, Hubei, China

    Recruiting

  • Fudan University Shanghai Cancer Centerpudong

    Shanghai, Shanghai Municipality, China

    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

Showing 18 of 18 sites. 18 of the 18 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07414836. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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