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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.

Phase 1RecruitingInstitut Paoli-CalmettesNCT05143970Data as of May 2026

Treatment: IPH5301 ALONE OR IN COMBINATION WITH CHEMOTHERAPY AND TRASTUZUMABCHANCES-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.

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Extracted 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

Min 1 prior line

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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