Study of BG-T187 Alone and in Combination With Other Therapeutic Agents in Participants With Advanced Solid Tumors

BeiGene

Status and phase: Enrolling; Phase 1

Conditions: Advanced Solid Tumor

Treatments: Drug: Other Therapeutic Agents; Drug: Drug: BG-T187

Study type: Interventional

Funder types: Industry

Identifiers

NCT06598800

2024-514944-10-00 (EU Trial (CTIS) Number)

BG-T187-101

Details and patient eligibility

About

This is a first-in-human (FIH), Phase 1a/1b, open-label, multicenter, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-T187 alone and in combination with other therapeutic agents in participants with advanced solid tumors.

Enrollment: 87 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. Participants must be ≥ 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
4. Participants with selected histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have been previously treated.
5. ≥ 1 measurable or nonmeasurable lesion as assessed by RECIST v1.1. for Phase 1a Part A; ≥ 1 measurable lesion per RECIST v1.1. for Phase 1a Part B and Phase 1b.
6. Adequate organ function.

Exclusion criteria

1. Prior severe allergic reactions or hypersensitivity to the active ingredient and excipients of BG-T187 or other monoclonal antibodies.
2. Spinal cord compression, active leptomeningeal disease, or uncontrolled, untreated brain metastasis.
3. Any malignancy ≤ 3 years before the first dose of study drug(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 (ILD) or noninfectious pneumonitis requiring steroids or other immune suppressive agents ≤ 2 years before the first dose of the study drug, or with current ILD/noninfectious pneumonitis, or where suspected ILD/noninfectious pneumonitis cannot be ruled out by imaging during screening.
5. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence ≤14 days after intervention).
6. Active hepatitis C.
7. Infection (including tuberculosis infection, or other) requiring systemic (oral or intravenous) antibacterial, antifungal, or antiviral therapy ≤ 14 days before the first dose of study drug(s).

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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87 participants in 5 patient groups

Phase 1a: Part A: Monotherapy Dose Escalation with Intravenous Administration

Experimental group

Description:

Sequential cohorts of increasing dose levels of BG-T187 will be evaluated as monotherapy.

Treatment:

Drug: Drug: BG-T187

Phase 1a: Part B: Monotherapy Dose Escalation with Subcutaneous Administration

Experimental group

Description:

Sequential cohorts of increasing dose levels of BG-T187 will be evaluated as monotherapy.

Treatment:

Drug: Drug: BG-T187

Phase 1a Part C: Safety Expansion

Experimental group

Description:

BG-T187 dose levels that have been determined to be safe and tolerable in Part A will be investigated.

Treatment:

Drug: Drug: BG-T187

Phase 1b: Monotherapy Dose Expansion with Subcutaneous Administration

Experimental group

Description:

Participants will receive BG-T187 monotherapy at the recommended dose(s) for expansion (RDFE) determined in Phase 1a.

Treatment:

Drug: Drug: BG-T187

Phase 1b: Combination Therapy: BG-T187 + Other Therapeutic Agents

Experimental group

Description:

Participants will receive BG-T187 in combination with Other Therapeutic Agents.

Treatment:

Drug: Drug: BG-T187

Drug: Other Therapeutic Agents