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Clinical Trial Summary

This is a 1:1 randomized, open label, multi-center phase I/II trial to evaluate the safety, dosing, efficacy, and biological activity of adding IMNN-001 to chemotherapy + BEV compared to chemotherapy + BEV alone.


Clinical Trial Description

This is a 1:1 randomized, open label, multi-center phase I/II trial to evaluate the safety, dosing, efficacy, and biological activity of adding IMNN-001 to chemotherapy + BEV compared to chemotherapy + BEV alone. The chemotherapy (NACT & adjuvant) will be a standard regimen of carboplatin + paclitaxel administered every three weeks for a total of 7-9 cycles. The protocol requires at least 4 cycles of NACT and allows up to 2 additional cycles of neoadjuvant therapy at the Investigator's discretion based on response and other clinical considerations. ICS will take place 3-4 weeks from last dose of NACT. Following at least a 4-week recovery from ICS, 3 additional adjuvant cycles of study treatments will be administered. The minimum time interval between surgery and BEV administration will be 4 weeks for safety. BEV will be included at Cycles 2, 3, 6, and 7. BEV may be substituted by an FDA approved biosimilar. The experimental arm will add IMNN-001 weekly to each cycle of chemotherapy + BEV beginning with cycle 1 day 15 and continue weekly through the last cycle of adjuvant therapy. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05739981
Study type Interventional
Source Imunon
Contact Sebastien Hazard, MD
Phone 609.896.9100
Email shazard@imunon.com
Status Recruiting
Phase Phase 1/Phase 2
Start date February 10, 2023
Completion date January 30, 2028

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