A Phase 1/1b Study to Evaluate the Safety and Tolerability of AB308 in Combination With AB122 in Participants With Advanced Malignancies

  • STATUS
    Recruiting
  • End date
    Dec 20, 2023
  • participants needed
    160
  • sponsor
    Arcus Biosciences, Inc.
Updated on 20 October 2022

Summary

This is a Phase 1/1b, multicenter, open-label, dose-escalation, and dose-expansion study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and clinical activity of AB308 in combination with zimberelimab (AB122) in participants with advanced malignancies.

Details
Condition Advanced Solid Tumor, NSCLC, Melanoma, Cervical Cancer, Multiple Myeloma, Lymphoma, Non-Hodgkin, DLBCL, Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, Esophageal Cancer
Treatment Zimberelimab, AB308
Clinical Study IdentifierNCT04772989
SponsorArcus Biosciences, Inc.
Last Modified on20 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
Male or female participants ≥ 18 years of age (or age ≥ regionally approved age of consent for participation in investigational clinical studies) at the time of signing the informed consent
Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
Adequate organ and marrow function

Exclusion Criteria

History of trauma or major surgery within 28 days prior to the first dose of study treatment
Prior treatment with an anti-TIGIT antibody
Any active or prior autoimmune disease that required treatment within 3 years of the first dose of study treatment
Prior chemotherapy, targeted small-molecule therapy, immunotherapy, or biologic agents, or use of other investigational drugs within 28 days before first dose of study treatment
Discontinued prior immunotherapy for immune related adverse events with a high severity
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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