CI

At a glance

ClinicalIndex Comparison Record
Phase 1Active· 27 target
Drug / intervention
IPH5301 ALONE OR IN COMBINATION WITH CHEMOTHERAPY AND TRASTUZUMABdrug
Likely dose
Not stated in record
Key inclusion· 10
  • ✓Incurable advanced and/or metastatic cancer
  • ✓Specific cancer types: breast, stomach, esophagus, pancreas, endometrium, ovary, lung
  • ✓HER2-positive or HER2-low breast cancer in cohort expansion
  • ✓At least one prior systemic therapy in advanced/metastatic setting
Key exclusion· 20
  • ✕Prior treatment with CD73 or adenosine pathway inhibitors
  • ✕Known spinal cord compression
  • ✕Grade 2 or higher peripheral neuropathy
  • ✕Symptomatic, untreated, or actively progressing CNS metastases

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05143970
NCT05143970Phase 1ActiveOn Track
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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

Institut Paoli-Calmettes·interventional·Posted Dec 3, 2021·Updated Jun 22, 2026

In Brief

A Phase 1 clinical trial evaluating IPH5301 ALONE OR IN COMBINATION WITH CHEMOTHERAPY AND TRASTUZUMAB for Metastatic Cancer and 8 related conditions. Active but no longer recruiting, targeting 27 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Cancer, Metastatic Breast Cancer, Metastatic Pancreatic Cancer, Metastatic Gastric Cancer, Metastatic Lung Cancer, Metastatic Ovary Cancer, Oesophageal Cancer, Endometrial Cancer, Advanced Solid Tumor
CountriesFrance
CollaboratorsInnate Pharma

Timeline

Phase 1Active
202220232024202520262027
First PostedDec 3, 2021
Enrollment StartJan 21, 2022
Primary CompletionMar 1, 2027
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 4.6 years agoPrimary completion in 8 months

Interventions

IPH5301 ALONE OR IN COMBINATION WITH CHEMOTHERAPY AND TRASTUZUMABdrug

Part I-Dose escalation Patients will receive IPH5301 alone on day 1 (Week 1). Treatment will be administered every 2 weeks until progression or unacceptable toxicity or other reasons requiring treatment discon-tinuation, for a maximum duration of 12 months. Part II- Expansion cohort Patients will receive IPH5301 at a recommended dose (RP2D) or a next lower dose (RP2D-1)in combination with trastuzumab and paclitaxel, at day 1 and every 2 weeks up to 6 cycles of paclitaxel. The RP2D dose will not exceed the designated maximum tolerated dose (MTD).