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RecruitingLast updated: 6 August 2026

Evaluating a new targeted treatment both as a standalone treatment and also when combined with immunotherapy (called Tislelizumab), in people with advanced solid cancersPhase 1a/1b Study of BG-C9074, an Antibody Drug Conjugate Targeting B7H4, as Monotherapy and in Combination With Tislelizumab in Participants With Advanced Solid Tumors

Trial purpose

Medical clipboardCancer treatment

Tumor type

Multi-Cancer Multi-Cancer

Age

People18+

Clinical summary

Summary

This trial is testing a new targeted cancer treatment called BG-C9074 in people with advanced solid tumours. BG-C9074 is an antibody-drug conjugate (ADC), a type of treatment designed to deliver medicine directly to cancer cells.

Researchers want to find out:

  • how safe BG-C9074 is
  • what side effects it may cause
  • how the body processes the treatment
  • what dose should be used in future studies
  • whether it shows signs of helping to treat cancer

You may be eligible for this study if you have:

  • an advanced, metastatic or unresectable solid cancer, such as:
    • HR+/HER-negative breast cancer
    • cholangiocarcinoma (bile duct cancer)
    • endometrial cancer
    • squamous non-small cell lung cancer
    • triple-negative breast cancer
    • ovarian cancer
  • received previous standard drug (systemic) treatment
  • a cancer not suitable for treatment with curative intent. or for which no further standard treatment options are available

Some participants will receive BG-C9074 on its own, while others will receive BG-C9074 together with another cancer treatment, such as the immunotherapy tislelizumab.

The treatments are given through a drip into a vein (IV infusion).

The study is being conducted in several stages. Early stages focus on finding safe dose levels, while later stages involve more participants to further assess safety and how well the treatment works.

Participants may continue receiving study treatment for up to 2 years, unless their cancer worsens, they experience unacceptable side effects, choose to leave the study, or another reason arises that requires treatment to stop.

 

Conditions

This trial is treating people with advanced solid tumours

Eligibility

Inclusion

  1. Able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection.
  2. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
  3. Participants with selected histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have previously received standard systemic therapy and whose cancer is not amenable to therapy with curative intent, and for whom further treatment is not available or not tolerated. Enrollment will be limited to participants with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer, cholangiocarcinoma (CCA), endometrial cancer, squamous non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), or ovarian cancer. Enrollment in the Japan cohort will be limited to participants with HR+/HER2- breast cancer, TNBC, endometrial cancer, or ovarian cancer.
  4. ≥ 1 measurable lesion per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1)
  5. Able to provide an archived tumor tissue sample.
  6. Adequate bone marrow and organ function.
  7. Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, and for ≥ 7 months after the last dose of study drug(s).
  8. Nonsterile males must be willing to use a highly effective method of birth control for the duration of the study treatment period and for ≥ 4 months after the last dose of study drug(s).

Exclusion

  1. Prior treatment with a B7 homolog 4 (B7H4)-targeting antibody-drug conjugate (ADC) or an ADC with a topoisomerase 1 inhibitor (TOP1i) payload.
  2. Active leptomeningeal disease or uncontrolled, untreated brain metastasis
  3. Any malignancy ≤ 2 years before the first dose of study treatment(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).
  4. History of interstitial lung disease, ≥ Grade 2 noninfectious pneumonitis, oxygen saturation at rest < 92%, or requirement for supplemental oxygen (including intermittent use) at baseline.
  5. Uncontrolled diabetes.
  6. Infection (including tuberculosis infection) requiring systemic (oral or intravenous) antibacterial, antifungal, or antiviral therapy ≤ 14 days before the first dose of study treatment(s).

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

 

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

BeiGene

Scientific Title

Phase 1a/1b Study of BG-C9074, an Antibody Drug Conjugate Targeting B7H4, as Monotherapy and in Combination With Tislelizumab in Participants With Advanced Solid Tumors

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