Trials / Recruiting
RecruitingNCT05143970
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
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 27 (estimated)
- Sponsor
- Institut Paoli-Calmettes · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Metastatic Cancer
- Metastatic Breast Cancer
- Metastatic Pancreatic Cancer
- Metastatic Gastric Cancer
- Metastatic Lung Cancer
- Metastatic Ovary Cancer
- Oesophageal Cancer
- Endometrial Cancer
- Advanced Solid Tumor
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | IPH5301 ALONE OR IN COMBINATION WITH CHEMOTHERAPY AND TRASTUZUMAB | 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). |
Timeline
- Start date
- 2022-01-21
- Primary completion
- 2027-03-01
- Completion
- 2027-03-01
- First posted
- 2021-12-03
- Last updated
- 2026-03-20
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT05143970. Inclusion in this directory is not an endorsement.