Phase 1a/1b First-in-Human Study of BG-C9074 Alone and in Combination With Tislelizumab in Participants With Advanced Solid Tumors

BeiGene

Status and phase: Enrolling; Phase 1

Conditions: Advanced Solid Tumor

Treatments: Drug: BG-C9074; Drug: Tislelizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06233942

2023-509958-65-00 (Other Identifier)

BG-C9074-101

Details and patient eligibility

About

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 tislelizumab in participants with advanced solid tumors.

Enrollment: 227 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 been previously treated.
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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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227 participants in 5 patient groups

Phase 1a: Part A (Monotherapy Dose Escalation)

Experimental group

Description:

BG-C9074 monotherapy dose escalation

Treatment:

Drug: BG-C9074

Phase 1a: Part B (Monotherapy Safety Expansion)

Experimental group

Description:

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

Treatment:

Drug: BG-C9074

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

Experimental group

Description:

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

Treatment:

Drug: Tislelizumab

Drug: BG-C9074

Phase 1b: Monotherapy Dose Expansion

Experimental group

Description:

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.

Treatment:

Drug: BG-C9074

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

Experimental group

Description:

Combination therapy will begin post-completion of combination dose escalation (Part C, Phase 1a).

Treatment:

Drug: Tislelizumab

Drug: BG-C9074