OncoMatch/Clinical Trials/NCT05143970
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
Is NCT05143970 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies IPH5301 ALONE OR IN COMBINATION WITH CHEMOTHERAPY AND TRASTUZUMAB for metastatic cancer.
Treatment: IPH5301 ALONE OR IN COMBINATION WITH CHEMOTHERAPY AND TRASTUZUMAB — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Breast Carcinoma
Pancreatic Cancer
Gastric Cancer
Non-Small Cell Lung Carcinoma
Esophageal Carcinoma
Endometrial Cancer
Biomarker criteria
Required: HER2 (ERBB2) amplification (IHC 3+ or gene amplification by in situ hybridization)
HER2-positive is defined by IHC 3+ or gene amplification by in situ hybridization
Required: HER2 (ERBB2) low expression (IHC 1+ or 2+ and no gene amplification by in situ hybridization)
HER2-low is defined by IHC 1+ or 2+ and no gene amplification by in situ hybridization
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic therapy — advanced/metastatic
Prior treatment with at least one prior systemic therapy in the advanced metastatic setting
Cannot have received: monoclonal antibodies or small molecules targeting CD73 or the adenosine pathway
Prior treatment with other monoclonal antibodies or small molecules targeting CD73 or the adenosine pathway
Lab requirements
Cardiac function
adequate echocardiogram, with a left ventricular ejection fraction ≥55%. patients with a history of lvef decline (< 50%) on anti-her2 treatment will not be allowed to participate.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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