NCT07749703

Brief 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).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
346

participants targeted

Target at P75+ for phase_1

Timeline
48mo left

Started Mar 2026

Longer than P75 for phase_1

Geographic Reach
1 country

6 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
Mar 2026Jun 2030

Study Start

First participant enrolled

March 31, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 6, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2030

Last Updated

August 6, 2026

Status Verified

April 1, 2026

Enrollment Period

2.3 years

First QC Date

August 3, 2026

Last Update Submit

August 3, 2026

Conditions

Histologically or Cytologically Confirmed Advanced Solid Tumors

Outcome Measures

Primary Outcomes (4)

  • Part 1: Dose-limiting toxicity (DLT)

    Cycle 1 Day 1 (C1D1) to Cycle 1 Day 21 (C1D21)

  • Part 1: Safety: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

    From informed consent signing to 30 days after the last dose

  • Part 2: Incidence and severity of subjects with AEs/SAEs

    From informed consent signing to 30 days after the last dose

  • Part 2: Objective response rate (ORR)

    About 24 months.

Secondary Outcomes (6)

  • Maximum plasma concentration (Cmax)

    About 24 months

  • Duration of response (DOR)

    About 24 months

  • Disease control rate (DCR)

    About 24 months

  • Time to response (TTR)

    About 24 months

  • Overall survival (OS)

    About 24 months

  • +1 more secondary outcomes

Study Arms (1)

Oral SIM0532

EXPERIMENTAL
Drug: SIM0532 Tablets

Interventions

SIM0532 TabletsDRUG

SIM0532 Tablets

Oral SIM0532

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Signed the informed consent form prior to performing the specified procedures required by the study.
  • \. Aged ≥18 years.
  • \. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
  • \. Expected survival ≥12 weeks.
  • \. Laboratory test results indicating sufficient organ function.
  • \. At least one measurable lesion per RECIST v1.1;

You may not qualify if:

  • \. A history of other malignant tumors within 2 years.
  • \. With symptomatic central nervous system (CNS) metastases.
  • \. Gastrointestinal diseases that affect drug administration/absorption.
  • \. Known psychiatric disorders or substance abuse that may interfere with the conduct of the study.
  • \. Uncontrolled pleural effusion, pericardial effusion or ascites requiring drainage or medical intervention within 4 weeks.
  • \. Any active infection requiring systemic treatment within 2 weeks.
  • \. A history of non-infectious pneumonia requiring oral or intravenous steroid therapy for recovery, or interstitial lung disease (ILD) or severe obstructive pulmonary disease.
  • \. Previous treatment with RAS-targeting therapies other than RAS (OFF) inhibitors.
  • \. Failure to recover from adverse events (AEs) caused by previous antineoplastic therapy.
  • \. Currently participating in or having participated in a study of other investigational drugs or devices within 4 weeks.
  • \. Major surgery within 4 weeks.
  • \. Previous antineoplastic therapy before the first dose of study treatment should have a certain wash-out period
  • \. Vaccination with any live vaccine within 4 weeks.
  • \. Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).
  • \. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection;
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

The First Affiliated Hospital of University of Science and Technology of China

Hefei, Anhui, China

Location

The First Hospital of China Medical University

Shenyang, Liaoning, China

Location

Shandong Cancer Hospital and Institute

Jinan, Shandong, China

Location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Location

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2026

First Posted

August 6, 2026

Study Start

March 31, 2026

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2030

Last Updated

August 6, 2026

Record last verified: 2026-04

Locations

CN(6)