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

NCT07749703
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Phase
Phase 1
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Recruitment status
Active, not recruiting
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Participants
346
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Lead sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.
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Start date
2026-03-31
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Number of sites
6
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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).
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Short title
A Phase I Study of SIM0532 in Adult Participants With Advanced Solid Tumors
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Official title
An Open-label, Multicenter, First-in-human Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of SIM0532 in Adult Participants With Advanced Solid Tumors
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2030-06-30
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First posted
2026-08-06
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Registry last updated
2026-08-11
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Primary completion date
2028-06-30
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Start date
2026-03-31
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Participants
346
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Participant count basis
Estimated
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Planned participants
346
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Protocol amendments
1
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Number of sites
6
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07749703
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ClinicalTrials.gov ID
NCT07749703
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Registry record
Open registry record
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Allocation
Not applicable
Model
Single group
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Part 1: Dose-limiting toxicity (DLT)

    Timeframe: Cycle 1 Day 1 (C1D1) to Cycle 1 Day 21 (C1D21) (Each cycle is 21 days)

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

    Timeframe: From informed consent signing to 30 days after the last dose

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

    Timeframe: From informed consent signing to 30 days after the last dose

  4. Part 2: Objective response rate (ORR)

    Timeframe: About 24 months.

  1. Maximum plasma concentration (Cmax)

    Timeframe: About 24 months

  2. Duration of response (DOR)

    Timeframe: About 24 months

  3. Disease control rate (DCR)

    Timeframe: About 24 months

  4. Time to response (TTR)

    Timeframe: About 24 months

  5. Overall survival (OS)

    Timeframe: About 24 months

  6. Progression-free survival (PFS)

    Timeframe: About 24 months

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

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

  • 1. A history of other malignant tumors within 2 years.
  • 2. With symptomatic central nervous system (CNS) metastases.
  • 3. Gastrointestinal diseases that affect drug administration/absorption.
  • 4. Known psychiatric disorders or substance abuse that may interfere with the conduct of the study.
  • 5. Uncontrolled pleural effusion, pericardial effusion or ascites requiring drainage or medical intervention within 4 weeks.
  • 6. Any active infection requiring systemic treatment within 2 weeks.
  • 7. A history of non-infectious pneumonia requiring oral or intravenous steroid therapy for recovery, or interstitial lung disease (ILD) or severe obstructive pulmonary disease.
  • 8. Previous treatment with RAS-targeting therapies other than RAS (OFF) inhibitors.
  • 9. Failure to recover from adverse events (AEs) caused by previous antineoplastic therapy.
  • 10. Currently participating in or having participated in a study of other investigational drugs or devices within 4 weeks.
  • 11. Major surgery within 4 weeks.
  • 12. Previous antineoplastic therapy before the first dose of study treatment should have a certain wash-out period
  • 13. Vaccination with any live vaccine within 4 weeks.
  • 14. Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).
  • 15. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection;
  • 16. A history of clinically significant cardiovascular disease.
  • 17. A history of allogeneic organ transplantation or graft-versus-host disease (GVHD).
  • 18. Known hypersensitivity to the study drug or any of its excipients.
  • 19. Participants who are pregnant or breastfeeding.
Sources for eligibility
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  • The First Affiliated Hospital of University of Science and Technology of ChinaHefei, China
  • The First Hospital of China Medical UniversityShenyang, China
  • Shandong Cancer Hospital and InstituteJinan, China
  • Fudan University Shanghai Cancer CenterShanghai, China
  • Shanghai Pulmonary HospitalShanghai, China
  • Zhejiang Cancer HospitalHangzhou, China
Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Collaborators (1)

Lead sponsors (1)

Targets (1)