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
N/A
Total Duration
On this page
Sponsors
I
Institut Paoli-Calmettes
Lead Sponsor
I
Innate Pharma
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the anti-CD73 drug IPH5301 in a first-in-human, Phase 1 study for adults with advanced or metastatic cancers, including breast, stomach, esophagus, pancreas, endometrium, ovary, and lung cancers. The study aims to find the highest dose of IPH5301 patients can tolerate alone, then explore its use combined with chemotherapy and trastuzumab in HER2-expressing breast cancer. This trial is designed to guide future treatments for advanced solid tumors. In the first part, patients receive increasing doses of IPH5301 every two weeks, up to 12 months, to determine the maximum tolerated dose and recommended dose for later studies. In the second part, 12 patients with HER2-positive breast cancer will receive IPH5301 combined with trastuzumab and paclitaxel every two weeks for up to six cycles. The dose used will not exceed the previously determined maximum tolerated dose. Participants will undergo regular monitoring for side effects and treatment response, including tumor measurements outside the brain. Those in the expansion phase must have adequate heart function and provide tumor biopsy samples. The main outcome is tracking dose-limiting toxicities within one month to assess safety. The study includes various assessments and follows participants until treatment discontinuation or unacceptable side effects occur, lasting up to 12 months or until cancer progression.
CONDITIONS
Brief 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
- Diagnosed with breast, stomach, esophagus, pancreas, endometrium, ovary, or lung carcinoma for dose escalation
- HER2-expressing breast cancer for cohort expansion, defined by local HER2 testing
- Prior treatment with at least one systemic therapy for advanced metastatic cancer
- ECOG performance status of 1 or less
- At least 18 years old
- Presence of at least one measurable lesion outside the central nervous system
- Adequate heart function with left ventricular ejection fraction of 55% or higher for cohort expansion
- Feasibility of tumor biopsy at study entry for cohort expansion
- All prior non-hematological side effects improved to Grade 1 or resolved except alopecia
You will not qualify if you...
- Prior treatment with other antibodies or small molecules targeting CD73 or adenosine pathway
- Known spinal cord compression
- Grade 2 or higher peripheral neuropathy
- Symptomatic, untreated, or progressing central nervous system metastases
- Allergic reactions to similar compounds
- Dyspnea at rest or history of pneumonitis/interstitial lung disease
- Serious medical conditions impairing treatment tolerance
- Concurrent enrollment in another interventional clinical trial
- Treatment with other anti-cancer agents during study
- Active autoimmune disease within past 2 years
- Grade 3 or higher immune-related adverse events from prior immunotherapy
- Major surgery within 28 days before study drug
- Cancer therapy within 28 days before study drug
- Live attenuated or SARS-CoV-2 vaccine within 30 days before first dose
- Primary immunodeficiency or history of allogeneic transplantation
- Current uncontrolled infection
- Hepatitis B, C, or HIV positive
- Other active invasive malignancies in past 3 years except certain low-risk cancers
- Pregnant or breastfeeding women
- Abnormal coagulation or recent thrombotic events
- Dementia or altered mental status preventing informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 12 months
Participants receive IPH5301 alone or in combination with chemotherapy and trastuzumab. In the dose escalation part, IPH5301 is given every 2 weeks until disease progression, unacceptable toxicity, or other reasons for discontinuation, for up to 12 months. In the expansion cohort, IPH5301 is given with trastuzumab and paclitaxel every 2 weeks for up to 6 cycles of paclitaxel.
Biweekly visits for treatment administration
Trial Site Locations
Total: 1 location
1
Institut Paoli Calmettes
Marseille, France
Actively Recruiting
Research Team
D
DOMINIQUE GENRE
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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