A Phase 1, Open-label, Multi-center Study of the Safety, Tolerability, and Efficacy of IPH4502 as a Single Agent in Advanced Solid Tumors
Innate Pharma
Summary
This is a first-in-human, open-label, multicenter, Phase 1 study to evaluate the safety, tolerability and preliminary efficacy of IPH4502 and to determine the recommended Phase 2 dose (RP2D) in advanced solid tumors that are known to express Nectin-4
Description
This is a first-in-human, open-label, multicenter, single-arm Phase 1 study, with a part 1 dose escalation guided by a Bayesian optimal interval design with backfilling (BOIN-BF), followed by a part 2 dose optimization in up to 2 selected indications. This study is to measure the safety, tolerability, pharmacokinetics, and preliminary efficacy of escalating doses of IPH4502 in patients with advanced solid tumors that are known to express Nectin-4.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Main Inclusion Criteria: * Histologically confirmed, unresectable, locally advanced or metastatic solid tumors that are known to express Nectin-4 * Prior systemic treatment for locally advanced or metastatic disease, yet no therapy with demonstrated clinical benefit for the tumor type is available. * Measurable disease according to RECIST 1.1. * Archival tumor tissue obtained within 4 months of screening and since the last anticancer therapy prior to the study or agree to undergo a tumor biopsy at baseline. * Adequate organ function and hematological function. Main Exclusion Criteria: * Kno…
Interventions
- DrugIPH4502
Part 1 (dose escalation) and Part 2 (dose optimization)
Locations (7)
- Massachusetts General Hospital - BostonBoston, Massachusetts
- John Theurer Cancer CenterHackensack, New Jersey
- Mount Sinai Tisch Cancer CenterNew York, New York
- NEXT Oncology - DallasDallas, Texas
- NEXT Oncology - VirginiaFairfax, Virginia
- Centre Léon BérardLyon