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Study of SIM0508 Alone and in Combination in Patients With Advanced Solid Tumors

NCT06686745 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2025-01-07

No results posted yet for this study

Summary

This is a multicenter, open-label, first-in-human study to evaluate the safety,efficacy, and PK/PD characteristics of SIM0508 as a single agent and in combination with olaparib in participants with locally advanced/metastatic solid tumors.

Conditions

Interventions

DRUG

SIM0508 Tablets

Every 28 days is one cycle. Multiple dose levels of SIM0508 will be explored in dose escalation, and determine the maximum tolerated dose.

DRUG

SIM0508 in combination with olaparib

Every 28 days is one cycle.Multiple dose levels of SIM0508 and olaparib will be explored in dose escalation, and determine the maximum tolerated dose.

DRUG

SIM0508 in combination with olaparib

Every 28 days is one cycle.Patients will be administered a potential recommended dose of SIM0508 combination with olaparib established from SIM0508 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
2024-12-06
Primary Completion
2027-06-30
Completion
2028-12-30
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 NCT06686745 on ClinicalTrials.gov