4175847
Last Update Posted: 2025-01-27
Recruiting
All Genders accepted | 18 Years-70 Years |
200 Estimated Participants | No Expanded Access |
Interventional Study | Does not accept healthy volunteers |
A Phase I /IIa Study of RC88-ADC in Subjects with Advanced Malignant Solid Tumors
This was a multicenter, open, multi-cohort extended PHASE I/IIa study, consisting of 2 phases:Phase I (Phase I dose escalation) and Phase II (Phase IIa multi-cohort extension). The objective of this study was to evaluate safety, tolerability, pharmacokinetic characteristics, and initial efficacy in malignant pleural mesothelioma and MSLN in advanced malignant solid tumors.
Phase I dose escalation phase：This study predicted a total of 6 dose groups, 0.1, 0.5, 1.0, 1.5, 2.0 and 2.5 mg/kg.
Phase IIa efficacy exploration phase:This phase is the multi-cohort indication expansion phase. Based on the data obtained in phase I, chose an appropriate dose continue to explore multi-cohort indications, including confirmed malignancy Pleural mesothelioma and MSLN expression were determined.
Eligibility
Relevant conditions:
Solid Tumor
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the study if you think are close to fitting criteria.
locations
Contact Information
Overall Contact
Xiaohong Su, M.D.
xiaohong.su@remegen.cn
+0810-65391479
Data sourced from ClinicalTrials.gov