A I/II Phase Clinical Study to Evaluate the Safety and Efficacy of RC288 in the Treatment of Solid Tumors
NCT07537881
Phase
Phase 1/Phase 2
Recruitment status
Not yet recruiting
Participants
Lead sponsor
RemeGen Co., Ltd.
Start date
2026-04-30
Number of sites
- 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;
- Short title
- A I/II Phase Clinical Study to Evaluate the Safety and Efficacy of RC288 in the Treatment of Solid Tumors
- 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.
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Not yet recruiting
- Phase
- Phase 1/Phase 2
- Study type
- Interventional
- Completion date
- 2030-06-30
- First posted
- 2026-04-17
- Registry last updated
- 2026-04-17
- Primary completion date
- 2029-12-30
- Start date
- 2026-04-30
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- RemeGen Co., Ltd.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07537881
- ClinicalTrials.gov ID
- NCT07537881
- Registry record
- Open registry record
- Allocation
- Not randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- No masking
Sources for study design
Dose-Limiting Toxicity (DLT)
Timeframe: 24 months
Incidence and severity of adverse events/serious adverse events (graded according to NCI CTCAE v6.0)
Timeframe: 24 months
Determine RP2D of RC288
Timeframe: 24 months
MTD and/or MAD
Timeframe: 24 months
Prostate Cancer Cohort: Investigator assessed ORR according to RECIST v1.1 criteria and PCWG3 criteria
Timeframe: 24 months
Non-Prostate Cancer Cohort: Investigator assessed ORR according to RECIST v1.1 criteria
Timeframe: 24 months
Sources for outcomes
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Healthy volunteers
- No
- Voluntarily participate in this study, sign the informed consent form, and be able to adhere to the study protocol;
- Age between 18 and 75 years (including 18 and 75 years);
- ECOG PS score of 0 or 1;
- Expected survival ≥12 weeks;
- According to RECIST v1.1 criteria, based on imaging examinations, there is at least one measurable target lesion;
- Sufficient bone marrow, liver, kidney, and blood clotting function
- Pregnant, breastfeeding, or intending to become pregnant subjects.
- Subjects with brain metastases.
- Subjects with unresolved toxicities from prior anti-tumor therapy not recovered to NCI-CTCAE v6.0 Grade 1.
- Subjects with known hypersensitivity or delayed allergic reactions to any component of the investigational drug or similar drugs.
- Subjects with acute, chronic, or symptomatic infections.
- Subjects with uncontrolled cardiovascular diseases.
- Subjects with confirmed or suspected interstitial lung disease (ILD), drug-related pneumonia, radiation pneumonitis, severely impaired pulmonary function, or other pulmonary diseases.
- History of underlying pulmonary disease.
- Subjects with a history of cirrhosis (Child-Pugh B or C class).
- Clinically significant gastrointestinal disease.
- Subjects with uncontrolled diabetes (HbA1c ≥ 10%).
- 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.
- 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.
- History of arterial/venous thromboembolic events within 6 months prior to the first dose.
- 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.
- History of active autoimmune disease requiring systemic therapy within the past 2 years.
- History of other invasive malignancies within 5 years prior to the first dose, or evidence of residual disease from any previously diagnosed malignancy.
- History of other acquired or congenital immunodeficiency diseases, or history of organ transplantation.
- History of or current poorly controlled psychiatric disorder.
- Poor compliance, and patients who are expected to be unable to cooperate with the completion of trial procedures.
- 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.
- 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
- Hunan Cancer HospitalChangsha, China
Sources for sites