A first-in-human, two-part, open-label, clinical study to assess the safety, tolerability, and activity of intravenous doses of ICT01 as monotherapy and in combination with an immune checkpoint inhibitor, in patients with advanced-stage, relapsed/refractory cancer (EVICTION Study)

Conditions

Advanced-stage, relapsed/refractory cancer

Brief summary

Part 1: • Incidence, severity (according to National Cancer Institute [NCI]- Common Terminology Criteria for Adverse Events [CTCAE] Version 5), and relationship to study treatment of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and TEAEs leading to discontinuation of study treatment or treatment modifications; • Incidence and severity of clinical laboratory abnormalities; • Clinically significant findings on vital signs, ECGs, and physical examinations., Part 2: • DCR according to RECIST Version 1.1 for solid tumors (complete response [CR] + partial response [PR] + stable disease [SD]); • Complete remission rate (CRR) according to the European LeukemiaNet (ELN) 2022 criteria for AML (complete remission [CR] + CR with partial hematological recovery [CRh] + CR with incomplete hematological recovery [CRi] + morphologic leukemia-free state [MLFS]).

Detailed description

Incidence of dose-limiting toxicities (DLTs), other safety measures, and biomarker data. • PK parameters of ICT01 • Disease control rate (DCR) and objective response rate (ORR) according to Response Evaluation Criteria In Solid Tumors, immunotherapy RECIST, Response Evaluation Criteria In Lymphoma, or as per disease-specific standards

Related papers

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Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Part 1: • Incidence, severity (according to National Cancer Institute [NCI]- Common Terminology Criteria for Adverse Events [CTCAE] Version 5), and relationship to study treatment of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and TEAEs leading to discontinuation of study treatment or treatment modifications; • Incidence and severity of clinical laboratory abnormalities; • Clinically significant findings on vital signs, ECGs, and physical examinations., Part 2: • DCR according to RECIST Version 1.1 for solid tumors (complete response [CR] + partial response [PR] + stable disease [SD]); • Complete remission rate (CRR) according to the European LeukemiaNet (ELN) 2022 criteria for AML (complete remission [CR] + CR with partial hematological recovery [CRh] + CR with incomplete hematological recovery [CRi] + morphologic leukemia-free state [MLFS]).	—

Measure

Time frame

Part 1: • Incidence, severity (according to National Cancer Institute [NCI]- Common Terminology Criteria for Adverse Events [CTCAE] Version 5), and relationship to study treatment of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and TEAEs leading to discontinuation of study treatment or treatment modifications; • Incidence and severity of clinical laboratory abnormalities; • Clinically significant findings on vital signs, ECGs, and physical examinations., Part 2: • DCR according to RECIST Version 1.1 for solid tumors (complete response [CR] + partial response [PR] + stable disease [SD]); • Complete remission rate (CRR) according to the European LeukemiaNet (ELN) 2022 criteria for AML (complete remission [CR] + CR with partial hematological recovery [CRh] + CR with incomplete hematological recovery [CRi] + morphologic leukemia-free state [MLFS]).

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Secondary

Measure	Time frame
Incidence of dose-limiting toxicities (DLTs), other safety measures, and biomarker data. • PK parameters of ICT01 • Disease control rate (DCR) and objective response rate (ORR) according to Response Evaluation Criteria In Solid Tumors, immunotherapy RECIST, Response Evaluation Criteria In Lymphoma, or as per disease-specific standards	—

Countries

Belgium, France, Germany, Spain

Outcome results

None listed