Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion

Description

Summary

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 in combination with tislelizumab in participants with 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

Keywords

Locally Advanced and Metastatic Solid Tumors BGB-A1217 Anti-TIGIT antibody Tislelizumab anti-PD-1 Neoplasms Paclitaxel Etoposide Albumin-Bound Paclitaxel Carboplatin Pemetrexed Nab paclitaxel Cisplatin

Eligibility

You can join if…

Open to people ages 18 years and up

    1. Has Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1;
  1. ≥ 1 measurable lesion per RECIST v1.1;
  2. Has adequate organ function. Phase 1
  3. 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

  1. Newly diagnosed histologically or cytologically confirmed stage IV NSCLC for cohort 1 and 2 (squamous for cohort 1 and non-squamous for cohort2);
  2. Newly diagnosed histologically or cytologically confirmed stage IV NSCLC with PD-L1 testing result positive (TPS≥1%) for cohort 3;
  3. Newly diagnosed histologically or cytologically confirmed extensive-stage SCLC for cohort 4;
  4. Histologically or cytologically confirmed NSCLC previously treated with standard systemic therapy with an anti-PD-(L)1 therapy in most recent line of treatment for cohort 5.

You CAN'T join if...

    1. Active brain or leptomeningeal metastasis.
  1. Active autoimmune diseases or history of autoimmune diseases that may relapse.
  2. 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).
  3. Concurrent participation in another therapeutic clinical trial.
  4. Received prior therapies targeting TIGIT.
  5. For patients with non-squamous NSCLC in Phase 1b, participants with sensitizing epidermal growth factor receptor (EGFR) mutation, anaplastic lymphoma kinase (ALK) fusion, and c-ros oncogene 1 (ROS1) fusion are excluded.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations

  • Moores Comprehensive Cancer Center/UC San Diego not yet accepting patients
    La Jolla California 92093 United States
  • Providence Portland not yet accepting patients
    Portland Oregon 97213 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
BeiGene
ID
NCT04047862
Phase
Phase 1
Study Type
Interventional
Last Updated