A Phase I Study of SIM0532 in Adult Participants With Advanced Solid Tumors (NCT07749703) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Phase I Study of SIM0532 in Adult Participants With Advanced Solid Tumors
China346 participantsStarted 2026-03-31
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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;
Exclusion Criteria:
* 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 o…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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