Actively Recruiting
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
Led by Institut Paoli-Calmettes · Updated on 2026-03-20
27
Participants Needed
1
Research Sites
266 weeks
Total Duration
On this page
Sponsors
I
Institut Paoli-Calmettes
Lead Sponsor
I
Innate Pharma
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with incurable advanced and/or metastatic cancer.
- Patients with carcinoma of the breast, stomach, esophagus, pancreas, endometrium, ovary, or lung for dose escalation.
- Patients with HER2-expressing breast cancer for the cohort expansion.
- Prior treatment with at least one systemic therapy in the advanced metastatic setting.
- For cohort expansion, patients must have received or be ineligible for all authorized standard treatments.
- Presence of at least one measurable lesion outside of the central nervous system.
- At least 18 years of age.
- ECOG performance status of 0 or 1.
- For cohort expansion, adequate heart function with left ventricular ejection fraction ≥55%.
- For cohort expansion, feasibility of obtaining a tumor biopsy at study entry.
- All non-hematological adverse events from prior therapy resolved or improved to Grade 1 (except alopecia).
You will not qualify if you...
- Prior treatment with monoclonal antibodies or small molecules targeting CD73 or the adenosine pathway.
- Known spinal cord compression.
- Grade 2 or higher peripheral neuropathy.
- Symptomatic, untreated, or actively progressing central nervous system metastases.
- Known allergies to similar compounds.
- Dyspnea at rest or history of pneumonitis/interstitial lung disease.
- Serious underlying medical conditions impairing treatment tolerance.
- Concurrent enrollment in another interventional clinical trial.
- Concurrent treatment with other anti-cancer agents.
- Active autoimmune disease within past 2 years.
- Grade 3 or higher immune-related adverse events or neurological/ocular immune events from prior immunotherapy.
- Major surgery within 28 days before study drug.
- Conventional or investigational anti-cancer therapy within 28 days before treatment.
- Live attenuated or SARS-CoV-2 vaccine within 30 days before first dose.
- Primary immunodeficiency or history of allogenic transplantation.
- Current uncontrolled infection.
- Hepatitis B, C, or HIV positive.
- Other active invasive malignancies within past 3 years except those with negligible metastasis risk.
- Pregnant or breastfeeding women.
- Abnormal coagulation or recent thrombotic events.
- Dementia or altered mental status preventing informed consent.
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Trial Site Locations
Total: 1 location
1
Institut Paoli Calmettes
Marseille, France
Actively Recruiting
Research Team
D
DOMINIQUE GENRE
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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