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
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
Drug | Synonyms | Arms |
---|
BGB-A1217 | | Phase 1 |
Tislelizumab | | Phase 1 |
Pemetrexed | | Phase 1b Cohort 2 |
Paclitaxel | | Phase 1b Cohort 1 |
Nab paclitaxel | | Phase 1b Cohort 1 |
Carboplatin | | Phase 1b Cohort 1 |
Cisplatin | | Phase 1b Cohort 2 |
Etoposide | | Phase 1b Cohort 4 |
5fluorouracil | | Phase1b Cohort 6 |
Oxaliplatin | | Phase1b Cohort 9 |
Capecitabine | | Phase1b 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
Name | Type | Description | Interventions |
---|
Phase 1 | Experimental | Cycle 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. | |
Phase 1b Cohort 1 | Experimental | Patients 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 2 | Experimental | Patients 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 3 | Experimental | Patients with metastatic NSCLC (PD-L1 positive, [TPS] ≥ 1%) will be treated with BGB-A1217 + tislelizumab | |
Phase 1b Cohort 4 | Experimental | Patients 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 5 | Experimental | Checkpoint inhibitor (CPI)-experienced NSCLC patients will be treated with BGB-A1217 plus tislelizumab | |
Phase1b Cohort 6 | Experimental | Patients 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 7 | Experimental | Patients 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 8 | Experimental | Patients with recurrent or metastatic HNSCC (PD-L1 positive, vCPS≥ 1%) will be treated with BGB-A1217 + tislelizumab Q3W | |
Phase1b Cohort 9 | Experimental | Patients 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