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Clinical Trials List

Protocol NumberBGB-900-105
NCT Number(ClinicalTrials.gov Identfier)NCT04047862
Completed

2020-10-26 - 2024-10-01

Phase I

Not yet recruiting7

Recruiting2

ICD-10C00.0

Malignant neoplasm of external upper lip

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9140.0

Malignant neoplasm of upper lip, vermilion border

Phase 1/1b Study Investigating Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Anti-TIGIT Monoclonal Antibody BGB-A1217 in Combination with Anti-PD-1 Monoclonal Antibody Tislelizumab (BGB-A317) in Patients with Unresectable Locally Advanced or Metastatic Solid Tumors

  • Trial Applicant

  • Sponsor

    BeiGene

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator TSUNG -YING YANG Division of Thoracic Medicine
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 林智斌 Division of Thoracic Medicine
Hualien Tzu Chi Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 夏和雄 Division of Hematology & Oncology
Taipei Tzu Chi Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Yuh-Min Chen Division of Thoracic Medicine
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Chia-Chi Lin Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Cheng-Ta Yang Division of Thoracic Medicine
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Chen-Yuan Lin Division of Hematology & Oncology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Shau-Hsuan Li Division of Hematology & Oncology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Gee-chen Chang Division of Thoracic Medicine
Chung Shan Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Advanced Solid Tumors

Objectives

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

Test Drug

BGB-A317 ; BGB-A1217

Active Ingredient

BGB-A317 ; BGB-A1217

Dosage Form

Concentrate for solution for infusion
Concentrate for solution for infusion

Dosage

10 mg/ml
20 mg/ml

Endpoints

Primary Outcome Measures :
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 ]
Phase 1 Dose Escalation - Number of participants experiencing Serious Adverse Events (SAEs) [ Time Frame: Up to 1.5 years ]
Phase 1 Dose Escalation - Recommended Phase Ib dose (RP2D) of BGB-A1217 in combination with tislelizumab [ Time Frame: Up to 1.5 years ]
Phase 1b Dose Confirmation - Anti-tumor activity of BGB-1217 in combination with tislelizumab in patients with select advanced solid tumors, in terms of objective response rate (ORR) as assessed by the Investigators using RECIST v. 1.1. [ Time Frame: Up to 1.5 years ]

Inclution Criteria

Phase 1 Key Inclusion Criteria

Has Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1.
≥ 1 measurable lesion per RECIST v1.1.
Has adequate organ function.
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

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 is 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.

ECOG Performance Status ≤ 1
Adequate organ function
Willing to use highly effective method of birth control

Exclusion Criteria

Phase 1 Key Exclusion Criteria:

Active brain or leptomeningeal 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 patients with hepatocellular carcinoma).
Concurrent participation in another therapeutic clinical trial.
Received prior therapies targeting TIGIT.
Phase 1b Key Exclusion Criteria:

Patients 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 patients 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 patients with hepatocellular carcinoma).
Concurrent participation in another therapeutic clinical study.

The Estimated Number of Participants

  • Taiwan

    37 participants

  • Global

    449 participants

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