Phase 1
Completed N=446
Study of Ociperlimab (BGB-A1217) in Combination With Tislelizumab in Advanced Solid Tumors
Locally Advanced and Metastatic Solid Tumors
Source: ClinicalTrials.gov NCT04047862 ↗
Enrolled (actual)
446
Serious AEs
49.3%
Results posted
Aug 2025
Primary outcomePrimary: Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) — 1; 3; 6; 15 Participants
Summary
The primary objectives of this study were: 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 was to assess overall response rate (ORR) determined by Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version (v).1.1 for patients in each dose-expansion cohort.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) |
1; 3; 6; 15; 6; 9 | — |
| PRIMARY Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Phase 1: Maximum Administered Dose (MAD) of Ociperlimab in Combination With Tislelizumab |
1800 | — |
| PRIMARY Phase 1: Recommended Phase 2 Dose (RP2D) of Ociperlimab in Combination With Tislelizumab |
900 | — |
| PRIMARY Phase 1b: Overall Response Rate (ORR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 |
55; 54.8; 40.0; 65.9; 7.7; 68.4 | — |
| SECONDARY Phase 1: ORR as Per RECIST v.1.1 |
0.0; 0.0; 16.7; 6.3; 20; 0.0 | — |
| SECONDARY Phase 1: Duration of Response (DOR) as Per RECIST v.1.1 |
2.8; 3.6; 8.4; 7 | — |
| SECONDARY Phase 1: Disease Control Rate (DCR) as Per RECIST v.1.1 |
0; 33.3; 50; 50; 40; 33.3 | — |
| SECONDARY Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab |
NA; NA; NA; NA; NA; 14.70 | — |
| SECONDARY Phase 1 (Dose Escalation): Serum Concentrations of Tislelizumab |
0.45; 16.50; 14.46; 18.60; NA; 54.60 | — |
| SECONDARY Phase 1 (Dose Verification): Serum Concentrations of Ociperlimab |
NA; NA; 313.57; 267.78; 230.81; 201.98 | — |
| SECONDARY Phase 1 (Dose Verification): Serum Concentrations of Tislelizumab |
NA; 62.35; 14.67; 33.34; 117.68; 36.41 | — |
| SECONDARY Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Phase 1b: DOR as Per RECIST v.1.1 |
16.9; 13.9; 14.0; 4.1; 15.9; 8.0 | — |
| SECONDARY Phase 1b: DCR as Per RECIST v.1.1 |
90.0; 92.9; 86.7; 90.2; 53.8; 94.7 | — |
| SECONDARY Phase 1b: Progression Free Survival (PFS) as Per RECIST v.1.1 |
8.2; 11.3; 5.5; 4.9; 2.9; 7.9 | — |
| SECONDARY Phase 1b (Cohorts 1-10): Number of Participants With TEAEs and TESAEs |
41; 43; 44; 43; 25; 21 | — |
| SECONDARY Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab |
NA; NA; NA; NA; NA; NA | — |
| SECONDARY Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab |
2.13; 45.40; 35.20; 1.35; 25.78; 36.00 | — |
| SECONDARY Phase 1b (Cohort 10): Serum Concentrations of Ociperlimab |
NA; NA; NA; 147.73; 309.74; 580.37 | — |
| SECONDARY Phase 1b (Cohort 10): Serum Concentrations of Tislelizumab |
NA; 2.94; NA; 68.42; 67.97; 63.62 | — |
| SECONDARY Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab |
0; 1; 0; 0; 0; 0 | — |
| SECONDARY Phase 1b (Cohort 1-10): Percentage of Participants With ORR: TIGIT Biomarkers Expression |
58.3; 22.2; 16.7; 22.2; 57.1; 38.5 | — |
| SECONDARY Phase 1b (Cohort 1-10): Percentage of Participants With ORR: PD-L1 Biomarkers Expression |
66.7; 60.0; 56.3; 42.9; 30.8; 0.0 | — |
| SECONDARY Phase 1b (Cohort 1-10): PFS in TIGIT Biomarkers Expression |
5.1; 2.7; 1.6; 5.5; 4.9; 2.8 | — |
| SECONDARY Phase 1b (Cohort 1-10): PFS in PD-L1 Biomarkers Expression |
7.0; 23.6; 6.9; 8.0; 5.2; 1.6 | — |
Eligibility Criteria
Key Inclusion Criteria
Phase 1 Key Inclusion Criteria
- Had Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to ( =) measurable lesion per RECIST v1.1.
- Had adequate organ function.
- Phase 1- Participants with histologically or cytologically confirmed advanced, metastatic, unresectable solid tumors who had previously received standard systemic therapy or for which treatment is not available, not tolerated or refused.
Phase 1b Key Inclusion Criteria
- Signed informed consent form (ICF) and able to comply with study requirements.
- Age >= 18 years (or the legal age of consent) at the time the ICF was signed.
- 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. Cohort 10: stage IV squamous or non-squamous NSCLC with PD-L1 positive.
- ECOG Performance Status <= 1
- Adequate organ function
- Were willing to use highly effective method of birth control
Phase 1 Key Exclusion Criteria:
- Active brain or leptomeningeal metastasis.
- Active autoimmune diseases or history of autoimmune diseases that could have relapsed.
- Had 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).
- Concurrent participation in another therapeutic clinical trial.
- Received prior therapies targeting TIGIT.
Phase 1b Key Exclusion Criteria:
- Participants with any prior therapy for recurrent/metastatic disease.
- Non-squamous NSCLC patients with sensitizing epidermal growth factor receptor (EGFR) mutation, anaplastic lymphoma kinase (ALK) fusion, and c-ros oncogene 1 (ROS1) fusion.
- Gastric cancer participants with squamous or with positive HER2 expression.
- Prior therapy with any drug specifically targeting T-cell co-stimulation or checkpoint pathways. (anti-PD(L)1 exception for Cohort 5).
- Active leptomeningeal disease or uncontrolled brain metastasis.
- Active autoimmune diseases or history of autoimmune diseases that may relapse.
- With severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection, etc. (antiviral therapy is permitted for participants with hepatocellular carcinoma).
- Concurrent participation in another therapeutic clinical study.
NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT04047862). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.