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RecruitingLast updated: 18 May 2026

This study will evaluate a new form of targeted therapy, 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 study will evaluate a new form of targeted therapy, called BG-C9074, both on its own and with immunotherapy called tislelizumab, to see how safe it is, how the body processes it, and if it helps treat advanced tumours.

BG-C9074 and Tislelizumab will be administered to participants via IV infusion. 

The study has multiple parts.

In Phase 1a Part A (Monotherapy Dose Escalation), BG-C9074 will be given by itself in escalating doses.

During Phase 1a Part B (Monotherapy Safety Expansion), the safety and effectiveness of BG-C9074 will be further investigated by administering it at the dose levels determined to be safe and tolerable in Part A.

In Phase 1a Part C (Combination Therapy Dose Escalation), participants will receive BG-C9074 plus Tislelizumab at the recommended dose for expansion (RDFE).

Phase 1b (Monotherapy Dose Expansion) will begin once the BG-C9074 monotherapy RDFE and dosing schedule have been determined from Parts A and B in Phase 1a. 

Participants will receive the treatments until their disease gets worse, they experience unacceptable side effects, withdraw from the study, or meet another reason for stopping. Participants may receive the treatments for up to two years.

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 been previously treated.
  4. ≥ 1 measurable lesion per RECIST v1.1.
  5. Able to provide an archived tumor tissue sample.
  6. Adequate 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 B7H4-targeting antibody drug conjugates (ADC)
  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 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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