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 (CHANCES)
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|ClinicalTrials.gov Identifier: NCT05143970|
Recruitment Status : Recruiting
First Posted : December 3, 2021
Last Update Posted : February 24, 2022
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+ cancer patients, respectively 6 breast cancer patients and 6 gastric 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.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Cancer Metastatic Breast Cancer Metastatic Pancreatic Cancer Metastatic Gastric Cancer Metastatic Lung Cancer Metastatic Ovary Cancer Oesophageal Cancer Endometrial Cancer Advanced Solid Tumor||Drug: IPH5301 ALONE OR IN COMBINATION WITH CHEMOTHERAPY AND TRASTUZUMAB||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||January 26, 2022|
|Estimated Primary Completion Date :||July 2023|
|Estimated Study Completion Date :||July 2024|
Experimental: IPH5301 administration
Part I- Dose escalation:
Escalating dose levels of IPH5301 will be evaluated.
Part II-Cohort Expansion:
IPH5301 will be administrated in combination with trastuzumab and paclitaxel
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).
- Occurrence of dose limiting toxicity (DLT) of IPH5301 in monotherapy in the dose escalation and in combination with paclitaxel and trastuzumab in the expansion cohort [ Time Frame: 1 month ]DLTs would include any grade 3 toxicity or higher that occurs during the first 4 weeks from the first injection of IPH5301, with the some exceptions
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05143970
|Contact: DOMINIQUE GENREemail@example.com|
|Institut Paoli Calmettes||Recruiting|
|Contact: Anthony Gonçalves, MD PhD firstname.lastname@example.org|
|Principal Investigator:||Anthony GONCALVES, MD PhD||Institut Paoli-Calmettes|