Study of Ociperlimab in Combination With Tislelizumab in Advanced Solid Tumors

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria - Phase 1:

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

Inclusion Criteria - Phase 1B

  • 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:

  • 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.

Exclusion Criteria - Phase 1B:

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

Eligibility last updated 11/11/21. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Harry Yoon, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Mohamad Sonbol, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Jason Starr, D.O.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available
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CLS-20523442

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