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

Phase 1RecruitingNCT06598800

BeiGene87 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Solid Tumor

Interventions

Drug: BG-T187DRUG

administered subcutaneously

Other Therapeutic AgentsDRUG

administered intravenously

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (25)

Outcomes

Primary Outcomes

Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

Number of participants with AEs including serious adverse events (SAEs), defined as any unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease temporally associated with the use of study drugs, whether considered related to study drugs or not as graded by the National Cancer Institute-Common Terminology Criteria for Adverse Events \[NCI CTCAE) V5.0/American Society for Transplantation and Cellular Therapy (ASTCT) for cytokine release syndrome \[CRS\] and immune effector cell associated neurotoxicity syndrome \[ICANS\]); and adverse events meeting protocol-defined dose-limiting toxicity (DLT) criteria

Time frame: Approximately 2 years

Phase 1a: Maximum Administered Dose (MAD) or Maximum Tolerated Dose (MTD) of BG-T187

MTD or MAD is defined as the highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 30% or the highest dose administered, respectively.

Time frame: Approximately 2 years

Phase 1a: Recommended Dose(s) for Expansion (RDFE[s]) of BG-T187

RDFE(s) is determined based on the MAD or MTD, taking into consideration the long-term tolerability, pharmacokinetics (PK), preliminary antitumor activity, and any other relevant data, as available

Time frame: Approximately 2 years

Phase 1b: Overall Response Rate (ORR)

ORR is defined as the percentage of participants with confirmed best overall response (BOR) complete response (CR) or partial response (PR) as determined by investigators per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Time frame: Approximately 2 years

Phase 1b: Recommended Phase 2 dose (RP2D) of BG-T187 alone and in combination with other therapeutic agents

R2PD is determined based on safety, tolerability, PK, preliminary antitumor activity, and other relevant data, as available

Central Contacts

Study Director

CONTACT

1.877.828.5568 clinicaltrials@beigene.com

Study Director

CONTACT

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Hackensack University Medical Center

Hackensack, New Jersey, United States

RECRUITING

The University of Texas Md Anderson Cancer Center

Houston, Texas, United States

RECRUITING

Next Virginia

Fairfax, Virginia, United States

RECRUITING

Washington University, St Louis, Division of Oncology

Madison, Wisconsin, United States

RECRUITING

Blacktown Cancer and Haematology Centre

Blacktown, New South Wales, Australia

RECRUITING

Macquarie University

North Ryde, New South Wales, Australia

RECRUITING

Cabrini Hospital Malvern

Malvern East, Victoria, Australia

RECRUITING

Linear Clinical Research

Nedlands, Western Australia, Australia

RECRUITING

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

RECRUITING

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

RECRUITING

...and 15 more locations

Secondary Outcomes

Phase 1a: ORR

ORR is defined as the percentage of participants with confirmed BOR, CR or PR as determined by investigators per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Time frame: Approximately 2 years

Phase 1a and 1b: Duration of Response (DOR)

DOR is defined as the time from the first objective response until the first documentation of disease progression after treatment initiation or death, whichever comes first, as determined by investigators per RECIST v1.1

Time frame: Approximately 2 years

Phase 1a and 1b: Disease Control Rate (DCR)

DCR is defined as the percentage of participants with the BOR of confirmed CR, PR, or stable disease, as determined by investigators per RECIST v1.1

Time frame: Approximately 2 years

Phase 1b: Progression Free Survival (PFS)

PFS is defined as the time from the date of the first administration of study drug to the date of the first documentation of disease progression or death due to any cause, whichever occurs first, as determined by investigators per RECIST v1.1

Time frame: Approximately 2 years

Phase 1a: Maximum observed plasma concentration (Cmax) of BG-T187

Time frame: From Cycle 1 to Cycle 3 (each cycle is 28 days)

Phase 1a: Area Under the Plasma Concentration-time Curve (AUC) of BG-T187

Time frame: From Cycle 1 to Cycle 3 (each cycle is 28 days)

Phase 1a: Terminal Half-Life (t1/2) of BG-T187

Time frame: From Cycle 1 to Cycle 3 (each cycle is 28 days)

Phase 1a: Time to maximum plasma concentration (Tmax) of BG-T187

Time frame: From Cycle 1 to Cycle 3 (each cycle is 28 days)

Phase 1a and 1b: Number of participants with anti-drug antibodies (ADAs) to BG-T187

Time frame: From Cycle 1 Day 1 up to 30 days after last dose (approximately 2 years)

Phase 1b: Number of Participants with AEs and SAEs

Time frame: Approximately 2 years