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A Study to Evaluate the Safety of KAND567, in Combination With Carboplatin Therapy, in Women With Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer — KANDOVA  

Fallopian Tube Cancer Clinical Trial

Official title:
KANDOVA - A Two-Part Phase Ib/IIa Study to Evaluate the Safety and Tolerability of KAND567, in Combination With Carboplatin Therapy, and to Determine the Recommended Phase II Dose (RPIID) of KAND567: An Open-Label, Multicenter Dose Escalation Study With an Expansion Cohort in Women With Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Clinical Trial Summary

The study is a multicenter, Phase Ib/IIa, open-label, dose-escalation study to evaluate the safety and tolerability of orally administered KAND567 in combination with carboplatin therapy, and to determine the Recommended Phase II Dose (RPIID) of KAND567 in combination with carboplatin in subjects with recurrent platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. In Part 1, dose escalation will be based on the recommendation of the Safety Review Committee (SRC) after review of the emerging safety and tolerability information. Once the RPIID has been identified in Part 1, the SRC may recommend to the Sponsor to start Part 2. An expansion cohort will be enrolled in Part 2 of the study to further evaluate the RPIID (approximately 20 subjects; may range from 6 to 24 subjects, depending on Part 1). If the number of subjects with confirmed CX3CR1 expression in tumor cells is below 50%, an additional 15 subjects may be included in Part 2 of the study.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06087289
Study type Interventional
Source Kancera AB
Contact Thomas Olin, PhD
Phone +46 (0) 850 12 60 80
Email thomas.olin@kancera.com
Status Recruiting
Phase Phase 1/Phase 2
Start date April 20, 2023
Completion date June 30, 2024
View Details
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