USO 25151
A Phase 1a/1b, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of IMGS-001 in Patients with Relapsed or Refractory Advanced Solid Tumors
Disease Types: Solid Tumors Research
Eligibility Requirements:
Part 1 Dose-escalation: Patients must have histologically confirmed locally advanced, or metastatic solid tumors who have progressed after receiving appropriate lines of standard therapy known to potentially confer clinical benefit.
Part 2 Dose-expansion: Patients must have histologically confirmed locally advanced, or metastatic cancer in one of the following pre-specified tumor types and meet tumor-specific criteria.
Patients eligible to enroll in cohorts with prior immune checkpoint therapy must meet the following criteria.
Ovarian cancer, HNSCC, and NSCLC patients participating in Part 2 (Phase 1b) must have confirmed PD-L1 positive expression (CPS ≥ 1 or TPS ≥ 50% [NSCLC only]).
Male or female ≥ 18 years of age.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Life expectancy > 3 months.
At least 1 measurable lesion as defined by RECIST 1.1. Subjects with lymphoma must have measurable disease as per Lugano Criteria (2014).
Patients must have a non-target lesion that can be biopsied. If a patient only has one target lesion (and no non-target lesions) the target lesion used for biopsy must be ≥ 2 cm in longest diameter.
Patients must have adequate bone marrow and organ function
For more information on the trial CLICK HERE .
Available at: