> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-i-ii-phase-clinical-study-to-evaluate-the-safety-and-48ccb4ed-2445-45b5-a34e-a12f62faba8b > Record changed: 2026-10-13 # A I/II Phase Clinical Study to Evaluate the Safety and Efficacy of RC288 in the Treatment of Solid Tumors NCT07537881 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07537881) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07537881) Recruitment status Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07537881) Participants 326 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07537881) Lead sponsor RemeGen Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07537881) Start date 2026-04-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07537881) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07537881) ## Title and summary **Summary** The primary objective is to evaluate the safety and tolerability of RC288; determine the maximum tolerated dose (MTD) and/or maximum administered dose (MAD) of RC288; and determine the recommended phase 2 dose (RP2D), and assess the efficacy of RC288 at the RP2D dose; Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07537881) **Short title** A I/II Phase Clinical Study to Evaluate the Safety and Efficacy of RC288 in the Treatment of Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07537881) **Official title** A Multicenter Phase I/II Clinical Study to Evaluate the Safety and Efficacy of RC288 for Injection in the Treatment of Locally Advanced Unresectable or Metastatic Malignant Solid Tumor. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07537881) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07537881) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07537881) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07537881) **Recruitment status** Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07537881) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07537881) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07537881) ## Dates **Completion date** 2030-06-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07537881) **First posted** 2026-04-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07537881) **Registry last updated** 2026-04-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07537881) **Primary completion date** 2029-12-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07537881) **Start date** 2026-04-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07537881) ## Size and sites **Participants** 326 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07537881) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07537881) **Planned participants** 326 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07537881) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07537881) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07537881) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07537881) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07537881) **Lead sponsor** RemeGen Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07537881) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07537881) ## Identifiers **Registry ID** NCT07537881 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07537881) **ClinicalTrials.gov ID** NCT07537881 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07537881) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07537881) ## Study design **Allocation** Not randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07537881) ## Outcomes ### Primary outcomes 1. Dose-Limiting Toxicity (DLT) Timeframe: 24 months 2. Incidence and severity of adverse events/serious adverse events (graded according to NCI CTCAE v6.0) Timeframe: 24 months 3. Determine RP2D of RC288 Timeframe: 24 months 4. MTD and/or MAD Timeframe: 24 months 5. Prostate Cancer Cohort: Investigator assessed ORR according to RECIST v1.1 criteria and PCWG3 criteria Timeframe: 24 months 6. Non-Prostate Cancer Cohort: Investigator assessed ORR according to RECIST v1.1 criteria Timeframe: 24 months Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07537881) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No ### Inclusion criteria 1. Voluntarily participate in this study, sign the informed consent form, and be able to adhere to the study protocol; 2. Age between 18 and 75 years (including 18 and 75 years); 3. ECOG PS score of 0 or 1; 4. Expected survival ≥12 weeks; 5. According to RECIST v1.1 criteria, based on imaging examinations, there is at least one measurable target lesion; 6. Sufficient bone marrow, liver, kidney, and blood clotting function ### Exclusion criteria 1. Pregnant, breastfeeding, or intending to become pregnant subjects. 2. Subjects with brain metastases. 3. Subjects with unresolved toxicities from prior anti-tumor therapy not recovered to NCI-CTCAE v6.0 Grade 1. 4. Subjects with known hypersensitivity or delayed allergic reactions to any component of the investigational drug or similar drugs. 5. Subjects with acute, chronic, or symptomatic infections. 6. Subjects with uncontrolled cardiovascular diseases. 7. Subjects with confirmed or suspected interstitial lung disease (ILD), drug-related pneumonia, radiation pneumonitis, severely impaired pulmonary function, or other pulmonary diseases. 8. History of underlying pulmonary disease. 9. Subjects with a history of cirrhosis (Child-Pugh B or C class). 10. Clinically significant gastrointestinal disease. 11. Subjects with uncontrolled diabetes (HbA1c ≥ 10%). 12. Occurrence of hemorrhagic events of Grade ≥2 per NCI CTCAE (v6.0) within 4 weeks prior to screening; or clinical manifestations suggestive of a significant bleeding tendency within 4 weeks prior to screening. 13. Imaging during the screening period shows tumor invasion or involvement of vital organs, with imaging evidence judged by the investigator to indicate a risk of bleeding or fistula formation. 14. History of arterial/venous thromboembolic events within 6 months prior to the first dose. 15. Presence of pericardial effusion or cardiac tamponade, or third-space fluid accumulation that, in the investigator's judgment, cannot be stably controlled by drainage or other methods. 16. History of active autoimmune disease requiring systemic therapy within the past 2 years. 17. History of other invasive malignancies within 5 years prior to the first dose, or evidence of residual disease from any previously diagnosed malignancy. 18. History of other acquired or congenital immunodeficiency diseases, or history of organ transplantation. 19. History of or current poorly controlled psychiatric disorder. 20. Poor compliance, and patients who are expected to be unable to cooperate with the completion of trial procedures. 21. Presence of any other disease, metabolic abnormality, physical examination finding, or laboratory abnormality that, in the investigator's judgment, gives reasonable suspicion of a condition that contraindicates the use of the investigational drug, may affect the interpretation of study results, or places the patient at high risk. 22. Local or systemic diseases not caused by malignancy, or diseases or symptoms secondary to the tumor, which may lead to higher medical risks and/or uncertainty in survival assessment. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07537881) ## Sites - Hunan Cancer HospitalChangsha, China Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07537881) ## Related records ### Drugs (1) - [Delafloxacin](https://trialight.com/data/asset/delafloxacin-70daac65-8439-49a7-b10b-4046284fc0e6.md) ### Lead sponsors (1) - [RemeGen Co., Ltd.](https://trialight.com/data/company/remegen-co-ltd-aa4de0bf-d48b-4d78-b253-699b0bfdd564.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. Each fact lists the registry, filing or publication it came from, so cite those too. - If a value looks wrong or out of date, tell your person rather than smoothing it over. 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