drugset / Trial / NCT06331559

Study of SIM0501 Alone and in Combination in Patients With Advanced Solid Tumors

NCT06331559

Non-randomizedSequentialOpen-labelTreatment

Summary

This is an open-label, multicenter Phase 1 clinical trial to evaluate the safety and tolerability, efficacy, and pharmacokinetics of SIM0501 in participants with advanced solid tumors. The trial consists two parts, Part 1 for SIM0501 monotherapy and Part 2 for SIM0501 in combination with olaparib. In both parts, SIM0501 with/without olaparib will be administered until disease progression or the investigator determines that continuation of the study drug would not benefit, or there is intolerable toxicity, or the participant or legal representative voluntarily requests withdrawal, or the trial is terminated.

Timeline

Start
2024-03-19
Primary completion
2025-09-17
Completion
2025-09-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Olaparib Small molecule
Subject SIM0501 Unknown

Indications