Advanced Solid Tumor
Conditions
Keywords
Advanced Solid Tumors, First-in-human, BG-T187, EGFR, c-MET
Brief summary
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.
Detailed description
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.
Interventions
DRUGDrug: BG-T187
administered subcutaneously
DRUGOther Therapeutic Agents
administered intravenously
Sponsors
BeOne Medicines
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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, including but not limited to non-small cell lung cancer (NSCLC), colorectal cancer (CRC). 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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 |
| Phase 1a: Maximum Administered Dose (MAD) or Maximum Tolerated Dose (MTD) of BG-T187 | 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. |
| Phase 1a: Recommended Dose(s) for Expansion (RDFE[s]) of BG-T187 | 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 |
| Phase 1b: Overall Response Rate (ORR) | 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 |
| Phase 1b: Recommended Phase 2 dose (RP2D) of BG-T187 alone and in combination with other therapeutic agents | Approximately 2 years | R2PD is determined based on safety, tolerability, PK, preliminary antitumor activity, and other relevant data, as available |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1a: ORR | 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 |
| Phase 1a and 1b: Duration of Response (DOR) | 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 |
| Phase 1a and 1b: Disease Control Rate (DCR) | 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 |
| Phase 1b: Progression Free Survival (PFS) | 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 |
| Phase 1a: Maximum observed plasma concentration (Cmax) of BG-T187 | From Cycle 1 to Cycle 3 (each cycle is 28 days) | — |
| Phase 1a: Area Under the Plasma Concentration-time Curve (AUC) of BG-T187 | From Cycle 1 to Cycle 3 (each cycle is 28 days) | — |
| Phase 1a: Terminal Half-Life (t1/2) of BG-T187 | From Cycle 1 to Cycle 3 (each cycle is 28 days) | — |
| Phase 1a: Time to maximum plasma concentration (Tmax) of BG-T187 | From Cycle 1 to Cycle 3 (each cycle is 28 days) | — |
| Phase 1b: Number of Participants with AEs and SAEs | 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) |
Countries
Australia, China, South Korea, United States
Contacts
CONTACTStudy Director
STUDY_DIRECTORStudy Director
BeOne Medicines
Outcome results
None listed