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

Keywords

• Advanced Solid Tumors
• First-in-human
• BG-T187
• EGFR
• c-MET

Lead sponsor

BeOne Medicines is the lead sponsor of 61 studies on the registry; 42 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Study arms

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

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

  Drug: Drug: BG-T187

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

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

  Drug: Drug: BG-T187

• Experimental
  Phase 1a Part C: Safety Expansion

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

  Drug: Drug: BG-T187

• Experimental
  Phase 1b: Monotherapy Dose Expansion with Subcutaneous Administration

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

  Drug: Drug: BG-T187

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

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

  Drug: Drug: BG-T187 · Drug: Other Therapeutic Agents

Interventions

• DrugDrug: BG-T187

  administered subcutaneously

• DrugOther Therapeutic Agents

  administered intravenously

Primary outcomes

1. 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

2. 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

3. 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

4. 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

5. 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

   Time frame: Approximately 2 years

Secondary outcomes

1. 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

2. 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

3. 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

4. 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

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

   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)

   Time frame: Approximately 2 years

Individual participant data

Plan to share: Yes — BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.

Supporting information: Study protocol, Sap, Csr