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A Phase I Study of SIM0532 in Adult Participants With Advanced Solid Tumors

NCT07749703 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 346

Last updated 2026-08-11

No results posted yet for this study

Summary

an open-label, multicenter, Phase I study designed to evaluate the safety, tolerability, efficacy, and pharmacokinetic/pharmacodynamic (PK/PD) characteristics of SIM0532 in participants with advanced solid tumors. The

study commences with a dose-escalation part (Part 1), followed by a dose-expansion part (Part 2).

Conditions

  • Histologically or Cytologically Confirmed Advanced Solid Tumors

Interventions

DRUG

SIM0532 Tablets

SIM0532 Tablets

Sponsors & Collaborators

  • Shanghai Xianwei Medical Technology Co., Ltd.

    collaborator INDUSTRY

  • Jiangsu Simcere Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2028-06-30
Completion
2030-06-30

Countries

  • China

Study Locations

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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 NCT07749703 on ClinicalTrials.gov