5739981
Last Update Posted: 2025-05-04
Recruiting
Females accepted | 18 Years + |
50 Estimated Participants | No Expanded Access |
Interventional Study | Does not accept healthy volunteers |
Phase II IMNN-001 (Also Known as GEN-1) on SLL With BEV and NACT, Newly Diagnosed Advanced Ovarian, Fallopian Tube or Primary Peritoneal Cancer
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.
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.
Eligibility
Relevant conditions:
Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Cancer
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 trial if you think are close to fitting criteria.
Inclusion criteria
Exclusion criteria
locations
Data sourced from ClinicalTrials.gov