Recruiting
Phase 1

BG-C9074 & Tislelizumab

Sponsor:

BeOne Medicines

Code:

NCT06233942

Conditions

Advanced Solid Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BG-C9074

Tislelizumab

Bevacizumab

Study Details

Brief summary:

This is a first-in-human, dose finding and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-C9074 alone and in combination with other anticancer therapies in patients with advanced solid tumors.

Conditions

Advanced Solid Tumor

Study ID

NCT06233942

Start date

Apr 12, 2024

Status verified date

Jun, 2026

Completion date

May 15, 2028

Anticipated

Primary completion date

Sep 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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 Criteria:

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.

Study Design

Enrollment

308 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase 1a: Part A (Monotherapy Dose Escalation)

BG-C9074 monotherapy dose escalation

experimental: Phase 1a: Part B (Monotherapy Safety Expansion)

BG-C9074 dose levels that have been determined to be safe and tolerable in Part A will be investigated.

experimental: Phase 1a: Part C (Combination Therapy Dose Escalation)

BG-C9074 plus tislelizumab combination at the recommended dose for expansion (RDFE).

experimental: Phase 1a: Part D (Japan Cohort)

A separate cohort in Japan will evaluate the safety of BG-C9074 monotherapy in Japanese participants with select solid tumors

experimental: Phase 1b: Monotherapy Dose Expansion

The monotherapy dose expansion phase will begin once the BG-C9074 monotherapy RDFE and dosing schedule have been determined from Parts A and B in Phase 1a.

experimental: Phase 1b: Combination Therapy Dose Expansion (BG-C9074 plus tislelizumab)

This arm will assess BG-C9074 plus tislelizumab as first-line therapy in select solid tumors after completion of the dose escalation phase.

experimental: Phase 1b: Combination Therapy Dose Expansion (BG-C9074 plus bevacizumab)

This arm will assess BG-C9074 plus bevacizumab in select solid tumors participants after establishing the recommended monotherapy dose and schedule.

Interventions

BG-C9074

administered by intravenous infusion

Tislelizumab

administered by intravenous infusion

Bevacizumab

administered by intravenous infusion

Primary outcome measure

  • Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Approximately 3 years ]
  • Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-C9074 [ Time Frame: Approximately 18 months ]
  • Phase 1a: Recommended Dose for Expansion (RDFE) of BG-C9074. [ Time Frame: Approximately 18 months ]
  • Phase 1b: Overall Response Rate (ORR) as monotherapy and in combination with tislelizumab [ Time Frame: Approximately 3 years ]
  • Phase 1b: Recommended Phase 2 dose (RP2D) of BG-C9074 as monotherapy and in combination with bevacizumab or tislelizumab [ Time Frame: Approximately 30 months ]

Central Contacts and Locations

Central contacts

Locations

Usc Norris Comprehensive Cancer Center (Nccc)

Recruiting

Los Angeles, California, United States, 90089-1019

University of Colorado Cancer Center

Recruiting

Aurora, Colorado, United States, 80045-2517

Florida Cancer Specialist Research Institute Lake Nona

Recruiting

Orlando, Florida, United States, 32827-7400

Sidney Kimmel Comprehensive Cancer At Johns Hopkins

Recruiting

Baltimore, Maryland, United States, 21287

James Cancer Hospital and Solove Research Institute

Recruiting

Columbus, Ohio, United States, 43210-1240

More Information

Sponsor

BeOne Medicines

Last update posted

Jul 8, 2026

Last verified

Jun, 2026

Keywords

  • BG-C9074
  • Tislelizumab
  • Advanced Solid Tumors
  • first-in-human
  • B7H4

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by BeOne Medicines on 2026-07-08.