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Recruiting Phase 1, Phase 2 NCT05269316

Study to Evaluate IMP9064 as a Monotherapy or in Combination in Patients With Advanced Solid Tumors

Trial Parameters

Condition Solid Tumor
Sponsor Impact Therapeutics, Inc.
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 61
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2022-02-11
Completion 2026-12-31
Interventions
IMP9064

Brief Summary

This is a Phase 1/2, multicenter, open-label study to evaluate the safety and efficacy of IMP9064 as monotherapy or in combination with PARP inhibitor Senaparib in patients with advanced solid tumors

Eligibility Criteria

Inclusion Criteria: 1. Patients ≥ 18 years of age on the day of signing informed consent form (ICF) (at the time of screening for Part 1 and Part 2C and pre-screening for Part 2A and Part 2B). 2. Must voluntarily participate in the study and be willing and able to provide signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. 3. Male or female patients with histologically or cytologically confirmed AST refractory to or intolerant of available standard-of-care therapy or for which no standard treatment exists. 4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 (Part 1) at screening. 5. Provision of tumor tissue samples. 6. Life expectancy ≥ 12 weeks (according to Investigator's judgement). 7. Female patients should meet at least 1 of the following criteria before they can participate in the study: 1. Females who have no childbearing potential (i.e. physiologically incapable of pregnancy), in

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