Clinical Trials /

Study of BGB-A1217 in Combination With Tislelizumab in Advanced Solid Tumors

NCT04047862

Description:

The primary objectives of this study are : to assess the safety and tolerability, to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and to determine the recommended Phase 2 dose (RP2D) of BGB-A1217 (known as Ociperlimab) in combination with tislelizumab in participants with advanced solid tumors in phase 1. Primary objective of Phase 1b is to assess overall response rate (ORR) determined by Investigator per RECIST v1.1 for patients in each dose- expansion

Related Conditions:
  • Malignant Solid Tumor
  • Small Cell Lung Carcinoma
  • Squamous Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Study of BGB-A1217 in Combination With Tislelizumab in Advanced Solid Tumors
  • Official Title: Phase 1/1b Study Investigating Safety, Tolerability, PK and Antitumor Activity of Anti-TIGIT Monoclonal Antibody BGB-A1217 in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: BGB-900-105
  • NCT ID: NCT04047862

Conditions

  • Locally Advanced and Metastatic Solid Tumors

Interventions

DrugSynonymsArms
BGB-A1217Phase 1
TislelizumabPhase 1
PemetrexedPhase 1b Cohort 2
PaclitaxelPhase 1b Cohort 1
Nab paclitaxelPhase 1b Cohort 1
CarboplatinPhase 1b Cohort 1
CisplatinPhase 1b Cohort 2
EtoposidePhase 1b Cohort 4
5fluorouracilPhase1b Cohort 6
OxaliplatinPhase1b Cohort 9
CapecitabinePhase1b Cohort 9

Purpose

The primary objectives of this study are : to assess the safety and tolerability, to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and to determine the recommended Phase 2 dose (RP2D) of BGB-A1217 (known as Ociperlimab) in combination with tislelizumab in participants with advanced solid tumors in phase 1. Primary objective of Phase 1b is to assess overall response rate (ORR) determined by Investigator per RECIST v1.1 for patients in each dose- expansion

Trial Arms

NameTypeDescriptionInterventions
Phase 1ExperimentalCycle 1 (28 Days): A flat dose of BGB-A1217 as a single agent on Day 1. In the first cycle, 200 mg tislelizumab will be administered on Day 8. If BGB-A1217 is tolerated in Cycle 1, participants will receive tislelizumab + BGB-A1217 sequentially on Day 29 and every 21 days for up to 8 months.
  • BGB-A1217
  • Tislelizumab
Phase 1b Cohort 1ExperimentalPatients with metastatic squamous NSCLC will receive BGB-A1217 + tislelizumab + paclitaxel/nab-paclitaxel + Carbo once every 3 weeks (Q3W) for 4 to 6 cycles (21 days each) followed by BGB-A1217+tislelizumab Q3W)
  • BGB-A1217
  • Tislelizumab
  • Paclitaxel
  • Nab paclitaxel
  • Carboplatin
Phase 1b Cohort 2ExperimentalPatients with metastatic squamous NSCLC will receive BGB-A1217 + tislelizumab + pemetrexed + Cis/Carbo Q3W for 4 to 6 cycles (21 days each) followed by BGB-A1217+tislelizumab Q3W)
  • BGB-A1217
  • Tislelizumab
  • Pemetrexed
  • Carboplatin
  • Cisplatin
Phase 1b Cohort 3ExperimentalPatients with metastatic NSCLC (PD-L1 positive, [TPS] ≥ 1%) will be treated with BGB-A1217 + tislelizumab
  • BGB-A1217
  • Tislelizumab
Phase 1b Cohort 4ExperimentalPatients with extensive stage SCLC will be treated with BGB-A1217 + tislelizumab + etoposide + Cis/Carbo Q3W for up to 6 to 8 cycles followed by BGB-A1217+tislelizumab Q3W
  • BGB-A1217
  • Tislelizumab
  • Carboplatin
  • Cisplatin
  • Etoposide
Phase 1b Cohort 5ExperimentalCheckpoint inhibitor (CPI)-experienced NSCLC patients will be treated with BGB-A1217 plus tislelizumab
  • BGB-A1217
  • Tislelizumab
Phase1b Cohort 6ExperimentalPatients with metastatic ESCC will be treated with BGB-A1217 + tislelizumab + cisplatin + 5-fluorouracil /paclitaxel Q3W for 6 cycles followed by BGB-A1217+tislelizumab Q3W
  • BGB-A1217
  • Tislelizumab
  • Paclitaxel
  • Cisplatin
  • 5fluorouracil
Phase1b Cohort 7ExperimentalPatients with metastatic EAC will be treated with BGB-A1217 + tislelizumab + cisplatin + 5-fluorouracil or paclitaxel Q3W for 6 cycles followed by BGB-A1217+tislelizumab Q3W
  • BGB-A1217
  • Tislelizumab
  • Paclitaxel
  • Cisplatin
  • 5fluorouracil
Phase1b Cohort 8ExperimentalPatients with recurrent or metastatic HNSCC (PD-L1 positive, vCPS≥ 1%) will be treated with BGB-A1217 + tislelizumab Q3W
  • BGB-A1217
  • Tislelizumab
Phase1b Cohort 9ExperimentalPatients with metastatic G/GEJ carcinoma will be treated with BGB-A1217 + tislelizumab + [oxalipatin + capecitabine] or [cisplatin + 5-fluorouracil] Q3W for 6 cycles followed by BGB-A1217+tislelizumab + capecitabine Q3W
  • BGB-A1217
  • Tislelizumab
  • Cisplatin
  • 5fluorouracil
  • Oxaliplatin
  • Capecitabine

Eligibility Criteria

        Key Inclusion Criteria:

        Phase 1 Key Inclusion Criteria

          1. Has Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1.

          2. ≥ 1 measurable lesion per RECIST v1.1.

          3. Has adequate organ function.

          4. phase 1- Patients with histologically or cytologically confirmed advanced, metastatic,
             unresectable solid tumors who have previously received standard systemic therapy or
             for which treatment is not available, not tolerated or refused.

        Phase 1b Key Inclusion Criteria

          1. Signed informed consent form (ICF) and able to comply with study requirements.

          2. Age ≥ 18 years (or the legal age of consent) at the time the ICF is signed.

          3. Histologically or cytologically confirmed tumor types in the following disease
             cohorts:

             Cohort 1: stage IV squamous NSCLC Cohort 2: stage IV non-squamous NSCLC Cohort 3:
             stage IV squamous or non-squamous NSCLC with PD-L1 positive. Cohort 4: extensive-stage
             SCLC Cohort 5: stage IIIB, IIIC or IV NSCLC Cohort 6: stage IV ESCC Cohort 7: stage IV
             EAC Cohort 8: recurrent or metastatic HNSCC incurable by local therapies Cohort 9:
             stage IV G/GEJ adenocarcinoma.

          4. ECOG Performance Status ≤ 1

          5. Adequate organ function

          6. Willing to use highly effective method of birth control

        Phase 1 Key Exclusion Criteria:

          1. Active brain or leptomeningeal metastasis.

          2. Active autoimmune diseases or history of autoimmune diseases that may relapse.

          3. With severe chronic or active infections requiring systemic antibacterial, antifungal
             or antiviral therapy, including tuberculosis infection, etc. (antiviral therapy is
             permitted for patients with hepatocellular carcinoma).

          4. Concurrent participation in another therapeutic clinical trial.

          5. Received prior therapies targeting TIGIT.

        Phase 1b Key Exclusion Criteria:

          1. Patients with any prior therapy for recurrent/metastatic disease.

          2. Non-squamous NSCLC patients with sensitizing epidermal growth factor receptor (EGFR)
             mutation, anaplastic lymphoma kinase (ALK) fusion, and c-ros oncogene 1 (ROS1) fusion.

          3. Gastric cancer patients with squamous or with positive HER2 expression.

          4. Prior therapy with any drug specifically targeting T-cell co-stimulation or checkpoint
             pathways. (anti-PD(L)1 exception for Cohort 5).

          5. Active leptomeningeal disease or uncontrolled brain metastasis.

          6. Active autoimmune diseases or history of autoimmune diseases that may relapse.

          7. With severe chronic or active infections requiring systemic antibacterial, antifungal
             or antiviral therapy, including tuberculosis infection, etc. (antiviral therapy is
             permitted for patients with hepatocellular carcinoma).

          8. Concurrent participation in another therapeutic clinical study.

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Phase 1 Dose Escalation - Number of participants experiencing Dose-Limiting Toxicities (DLTs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v.5.0)
Time Frame:Up to 28 Days in Cycle 1
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Duration of response (DOR)
Time Frame:Up to 3 years
Safety Issue:
Description:Duration of response (DOR) will be determined from investigator derived tumor assessments per RECIST v. 1.1.
Measure:Disease control rate (DCR)
Time Frame:Up to 3 years
Safety Issue:
Description:Disease control rate (DCR) will be determined from investigator derived tumor assessments per RECIST v. 1.1.
Measure:Progression free survival
Time Frame:Up to 3 years
Safety Issue:
Description:Progression free survival will be determined from investigator derived tumor assessments per RECIST 1.1.
Measure:Immunogenicity as assessed by the presence of anti-drug antibodies
Time Frame:Up to 3 years
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:BeiGene

Trial Keywords

  • BGB-A1217
  • Anti-TIGIT antibody
  • Tislelizumab
  • anti-PD-1

Last Updated

April 15, 2021