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NCT Number: NCT06598800

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

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.

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Key information

Conditions

Advanced Solid Tumor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Blacktown Cancer and Haematology Centre, Blacktown, New South Wales, Australia

Loading trial locations.

About this study

Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection.
  • Participants must be ≥ 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
  • Participants with selected histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have been previously treated, including but not limited to non-small cell lung cancer (NSCLC), colorectal cancer (CRC).
  • ≥ 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.
  • Adequate organ function.

Exclusion criteria

  • Prior severe allergic reactions or hypersensitivity to the active ingredient and excipients of BG-T187 or other monoclonal antibodies.
  • Spinal cord compression, active leptomeningeal disease, or uncontrolled, untreated brain metastasis.
  • 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).
  • 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.
  • Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence ≤14 days after intervention).
  • Active hepatitis C.
  • 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.

Treatment and study plan

Drug: BG-T187

Drug

administered subcutaneously

Other Therapeutic Agents

Drug

administered intravenously

Primary outcomes

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

    Time frame: Approximately 2 years

    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

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

    Time frame: Approximately 2 years

    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.

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

    Time frame: Approximately 2 years

    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

  4. Phase 1b: Overall Response Rate (ORR)

    Time frame: Approximately 2 years

    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

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

    Time frame: Approximately 2 years

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

Secondary outcomes

  1. Phase 1a: ORR

    Time frame: Approximately 2 years

    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

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

    Time frame: Approximately 2 years

    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

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

    Time frame: Approximately 2 years

    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

  4. Phase 1b: Progression Free Survival (PFS)

    Time frame: Approximately 2 years

    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

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

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

  6. 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)

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

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

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

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

  9. Phase 1b: Number of Participants with AEs and SAEs

    Time frame: Approximately 2 years

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Study Director

CONTACT

[email protected]

1.877.828.5568

Study Director

CONTACT

Sponsors and collaborators

Lead sponsor

BeOne Medicines

Industry

Registry information

Official study title

A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of BG-T187, an EGFR×MET Trispecific Antibody, Alone and in Combination With Other Therapeutic Agents in Patients With Advanced Solid Tumors

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Sep 19, 2024
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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