South Texas Accelerated Research Therapeutics | START Midwest
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The primary purpose of this study is to assess the safety and tolerability of AB801 in participants with advanced malignancies, and to determine a recommended AB801 dose for expansion.
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Inclusion and exclusion criteria
Key Inclusion Criteria:
Monotherapy-specific criteria for dose escalation cohorts:
Disease-specific criteria for dose-expansion Cohort 1 (STK11m [mutated or deleted] NSCLC):
Disease-specific criteria for dose-expansion Cohort 2 (NSCLC):
Must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) guidance (Version 1.1) (Section 1.1). The measurable lesion must be outside of a radiation field if the participant received prior radiation unless discussed and approved by the study physician.
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Primary purpose
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Interventional model
Masking
80 participants in 8 patient groups
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Data sourced from clinicaltrials.gov
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