A I/II Phase Clinical Study to Evaluate the Safety and Efficacy of RC288 in the Treatment of Soli… (NCT07537881) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
A I/II Phase Clinical Study to Evaluate the Safety and Efficacy of RC288 in the Treatment of Solid Tumors
China326 participantsStarted 2026-04-30
Plain-language 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;
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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.
What they're measuring
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