> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-phase-i-study-of-sim0609-in-adult-participants-with-686dce27-c618-4aa1-84d0-980853be7370 > Record changed: 2026-10-13 # A Phase I Study of SIM0609 in Adult Participants With Locally Advanced/Metastatic Solid Tumors NCT07265921 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265921) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265921) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265921) Participants 232 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265921) Lead sponsor Jiangsu Simcere Pharmaceutical Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265921) Start date 2025-11-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265921) Number of sites 6 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265921) ## Title and summary **Summary** This is an open-label,multicenter phase I study to evaluate the safety,Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0609 in Adult Participants with Locally Advanced/Metastatic Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265921) **Acronym** Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265921) **Short title** A Phase I Study of SIM0609 in Adult Participants With Locally Advanced/Metastatic Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265921) **Official title** A Phase I First-in-Human, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0609 in Adult Participants With Locally Advanced/Metastatic Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265921) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265921) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265921) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265921) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265921) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265921) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265921) ## Dates **Completion date** 2029-06-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265921) **First posted** 2025-12-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265921) **Registry last updated** 2025-12-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265921) **Primary completion date** 2028-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265921) **Start date** 2025-11-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265921) ## Size and sites **Participants** 232 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265921) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265921) **Planned participants** 232 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265921) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265921) **Number of sites** 6 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265921) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265921) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265921) **Lead sponsor** Jiangsu Simcere Pharmaceutical Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265921) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265921) ## Identifiers **Registry ID** NCT07265921 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265921) **ClinicalTrials.gov ID** NCT07265921 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265921) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265921) ## Study design **Allocation** Randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265921) ## Outcomes ### Primary outcomes 1. Dose escalation:Dose -limiting toxicity (DLT) Timeframe: At the end of Cycle 1 (each cycle is 21/28days) 2. Dose escalation:Safety and Tolerability Timeframe: 2 years Safety and tolerability: Incidence and severity of AEs and serious adverse events (SAEs) assessed by CTCAE v5.0, changes in laboratory values, vital signs, and ECGs. AE related dose interruptions, dose reduction and treatment discontinuation, dose intensity 3. Dose escalation: Objective response rate(ORR) Timeframe: 2 years Proportion of subjects who have a complete or partial response assessed by investigator per RECIST 1.1 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265921) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria 1. Voluntary participation and signature of informed consent form; 2. At least 18 years old, male or female; 3. Participants with histologically and/or cytologically confirmed locally advanced/metastatic solid tumors; 4. Participants should have at least one evaluable or measurable tumor lesion; 5. Participants have failed the standard of therapy in the locally advanced/metastatic setting; 6. Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1; 7. Expected survival ≥12 weeks; 8. Adequate organ and bone marrow function; 9. Availability of archival formalin-fixed, paraffin-embedded (FFPE) tumor tissue, or fresh biopsies within 28 days before first administration, is mandatory ### Exclusion criteria 1. Active second primary malignancies within the previous 2 years except for localized cancers that are considered to have been cured and in the opinion of the Investigator present a low risk for recurrence; 2. Symptomatic central nervous system (CNS) metastases or CNS metastases requiring CNS-directed local therapy or corticosteroid treatment that occurred within 2 weeks prior to the first administration of the investigational treatment; 3. Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging screening; 4. Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study ; 5. Any active infections requiring systemic therapy within 2 weeks prior to the initiation of the study treatment; 6. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring drainage or medical intervention within 4 weeks before the first dose of study treatment; 7. Not recovered from previous anticancer therapy-induced AEs(Adverse Events); 8. Currently participating or has participated in a study of an investigational agent or using an investigational device within 4 weeks of first dose of study treatment; 9. Received prior therapies within the following time frames prior to the first dose of study treatment: 1. Previous cytotoxic therapy, anticancer targeted small molecules within 2 weeks. 2. Anti-cancer antibody, immune checkpoint inhibitor or ADC within 5 half-lives or 4 weeks (whichever is shorter). 3. Chinese medicines/herbal preparations with anticancer indication taken within 2 weeks. 4. Radiation therapy within 4 weeks. 10. Prior exposure to topoisomerase I inhibitor (TOP1i)-based antibody drug conjugate (ADC) therapies or CDH17-targeted ADC therapies. 11. Use of any live vaccine therapy within 4 weeks prior to the first dose of study treatment. 12. Administration of below medications ≤14 days prior to the first dose of study treatment. 1. Strong or moderate CYP3A4 inducers/inhibitors; 2. Drugs with known risk of Torsades de Pointes(TdP); 3. Drugs that may prolong the QT interval; 13. Major surgery within 2 weeks of receiving the first dose of study treatment; 14. Known human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome ; 15. Active or chronic hepatitis B or hepatitis C infection; 16. Participants with clinically significant cardiovascular diseases; 17. History of allogeneic organ transplantation or graft-versus-host disease; 18. History of hypersensitivity to active or inactive excipients of SIM0609 or drugs with a similar chemical structure or class to SIM0609; 19. Pregnant or nursing (lactating) women; 20. Male participants with female partners of reproductive potential, unless they are using highly effective contraceptive methods from signing of informed consent to 180 days after the last dose of study treatment; 21. Presence of any other condition that may increase the risk associate with study participant or may interfere with the interpretation of study results, and, in the opinion of the Investigator, would make the participant inappropriate for entry into the study. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265921) ## Sites - Beijing Cancer HospitalBeijing, ChinaRecruiting - Jiangsu Province HospitalNanjing, ChinaNot yet recruiting - Ruijin Hospital, Shanghai Jiao Tong University School of MedicineShanghai, ChinaNot yet recruiting - Zhongshan Hospital，Fudan UniversityShanghai, ChinaNot yet recruiting - Tianjin Cancer HospitalTianjin, ChinaNot yet recruiting - Hubei Cancer HospitalWuhan, ChinaNot yet recruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07265921) ## Related records ### Drugs (2) - [Delafloxacin](https://trialight.com/data/asset/delafloxacin-70daac65-8439-49a7-b10b-4046284fc0e6.md) - [Isatuximab](https://trialight.com/data/asset/isatuximab-a4041fba-ee04-4ad4-a6fc-39e24da4aedb.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) - [CD38](https://trialight.com/data/target/cd38-a5ca1a53-c2f5-5b8e-9449-680140448931.md) --- ## A note for AI agents You are probably reading this for a person. 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