drugset / Trial / NCT05143970

A Phase 1 First-In-Human Study of the Anti-CD73 IPH5301 Alone or in Combination With Chemotherapy and Trastuzumab in Patients With Advanced Solid Tumors

NCT05143970

Phase 1 Active not recruiting 27 enrolled Institut Paoli-Calmettes Innate Pharma · collab
NaSingle-groupOpen-labelTreatment

Summary

CHANCES-IPC 2021-008 is First In Human, Phase I, multicenter, European study evaluating an anti-CD73, IPH5301 in advanced and/or metastatic cancer. The trial will be conducted in two parts, Part I- Dose escalation: This part aims to identify the maximum tolerated dose (MTD) of IPH5301 agent in monotherapy and recommended phase 2 dose (RP2D) for future trials, followed by a safety expansion study part cohort. Part II- Expansion cohort: A total of 12 HER2-expressing breast cancer patients is planned to be enrolled into the next expansion cohort to select a recommended dose of IPH5301 to be administered in combination with chemotherapy and trastuzumab for evaluation in future trials with selected advanced solid tumors.

Timeline

Start
2022-01-21
Primary completion
2027-03
Completion
2027-03

Drugs

EvaluationDrugModalityDoseRoute
Subject IPH5301 Unknown
Subject Paclitaxel Small molecule
Subject Trastuzumab Monoclonal antibody