Phase I/IIa Clinical Trial Evaluating the Safety and Efficacy of IMC001 in Patients With Advanced Epithelial Solid Tumors.

Study Summary

This is an open -label phase I /IIa study designed to evaluate the safety and efficacy of IMC001 in patients with advanced epithelial solid tumors. The study comprises two parts: a phase I dose-escalation phase and a phase IIa phase to further explore and validate efficacy .In the Phase I dose-escalation phase of this study, approximately 7-15 subjects with advanced epithelial solid tumors will be recruited to evaluate the safety and tolerability of autologous IMC001 treatment . In the expansion phase, at least two dose groups will be selected , each recruiting 5-10 subjects. Combined with the subjects from the escalation phase, each dose group will be expanded to approximately 10 subjects to determine the recommended RP2D dose for progression to Phase IIa . DLT ( digestive tract aging) assessment will be performed on subjects in each cohort within 28 days of IMC001 infusion . the RP2D is determined , approximately 6-20 subjects will be initially enrolled at this dose for each selected tumor type to further explore the efficacy and safety of autologous IMC001 for this indication. Subsequently, the protocol may be revised based on statistical hypotheses and regulatory requirements to continue enrolling subjects in the selected tumor types to further validate the efficacy and safety in specific tumor types.the date on which the last participant completes a two-year follow-up visit, is lost to follow up, withdraws informed consent, or dies (whichever occurs first) . It is important to note that for long-term follow-up programs such as ADA, RCL, and VIS (up to 15 years), which require protocol-based follow-up, these follow-ups will be conducted continuously according to protocol and regulatory requirements. However, the actual study participation time for each participant will vary depending on screening requirements, response to treatment, long-term follow-up arrangements, and survival status .

Interventions

Study Locations

Official Trial Information