> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-phase-i-study-of-sim0532-in-adult-participants-with-862a47b3-6c4b-4a68-af9d-0455eb49f54d > Record changed: 2026-10-13 # A Phase I Study of SIM0532 in Adult Participants With Advanced Solid Tumors NCT07749703 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07749703) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07749703) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07749703) Participants 346 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07749703) Lead sponsor Jiangsu Simcere Pharmaceutical Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07749703) Start date 2026-03-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07749703) Number of sites 6 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07749703) ## Title and summary **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). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07749703) **Short title** A Phase I Study of SIM0532 in Adult Participants With Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07749703) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07749703) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07749703) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07749703) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07749703) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07749703) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07749703) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07749703) ## Dates **Completion date** 2030-06-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07749703) **First posted** 2026-08-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07749703) **Registry last updated** 2026-08-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07749703) **Primary completion date** 2028-06-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07749703) **Start date** 2026-03-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07749703) ## Size and sites **Participants** 346 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07749703) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07749703) **Planned participants** 346 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07749703) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07749703) **Number of sites** 6 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07749703) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07749703) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07749703) **Lead sponsor** Jiangsu Simcere Pharmaceutical Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07749703) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07749703) ## Identifiers **Registry ID** NCT07749703 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07749703) **ClinicalTrials.gov ID** NCT07749703 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07749703) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07749703) ## Study design **Allocation** Not applicable **Model** Single group **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07749703) ## Outcomes ### Primary outcomes 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. ### Secondary outcomes 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07749703) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07749703) ## Sites - 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07749703) ## Related records ### Drugs (1) - [Medroxyprogesterone acetate](https://trialight.com/data/asset/medroxyprogesterone-acetate-5514a525-6952-4a47-8871-8a2425a74366.md) ### Collaborators (1) - Shanghai Xianwei Medical Technology Co., Ltd. ### Lead sponsors (1) - [Jiangsu Simcere Pharmaceutical Co., Ltd.](https://trialight.com/data/company/jiangsu-simcere-pharmaceutical-co-ltd-c562a90c-ad12-4011-96b9-b0005ac2bf4f.md) ### Targets (1) - [PGR](https://trialight.com/data/target/pgr-4e536b31-8799-5ace-a427-be36fd8a5f9f.md) --- ## A note for AI agents You are probably reading this for a person. 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