MedTrace Logo

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

NCT06331559 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2026-02-09

No results posted yet for this study

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.

Conditions

Interventions

DRUG

SIM0501 Tablets

Every 28 days is one cycle. Multiple dose levels of SIM0501 will be explored in dose escalation, and determine the maximum tolerated dose.

DRUG

SIM0501 Tablets

Every 28 days is one cycle.Patients will be administered a potential recommended dose of SIM0501 established from SIM0501 mono dose escalation.

DRUG

SIM0501 in combination with olaparib

Every 28 days is one cycle.Multiple dose levels of SIM0501 and olaparib will be explored in dose escalation, and determine the maximum tolerated dose.

DRUG

SIM0501 in combination with olaparib

Every 28 days is one cycle.Patients will be administered a potential recommended dose of SIM0501 combination with olaparib established from SIM0501 combination dose escalation.

Sponsors & Collaborators

  • Shanghai Xianxiang Medical Technology Co., Ltd.

    collaborator INDUSTRY

  • Jiangsu Simcere Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-19
Primary Completion
2025-09-17
Completion
2025-09-17
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06331559 on ClinicalTrials.gov