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OncoMatch/Clinical Trials/NCT05024214

Phase Ib/II Trial of Envafolimab Plus Lenvatinib for Subjects With Solid Tumors

Is NCT05024214 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Lenvatinib + Envafolimab and Sunitinib for solid tumors.

Phase 1/2Recruiting3D Medicines (Sichuan) Co., Ltd.NCT05024214Data as of May 2026

Treatment: Lenvatinib + Envafolimab · SunitinibThis is an open-label, multi-center study of Phase Ib/II study to assess the efficacy and safety of Envafolimab combinded with Lenvatinib in the treatment of subjects with advanced solid tumors. The primary hypothesis of this study is that subjects will have a better objective response rate (ORR) when treated with Envafolimab plus Lenvatinib than SOC.

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Extracted eligibility criteria

Cancer type

Tumor Agnostic

Non-Small Cell Lung Carcinoma

Renal Cell Carcinoma

Hepatocellular Carcinoma

Disease stage

Required: Stage III, IV

Metastatic disease required

Locally advanced or metastatic solid tumors; Unresectable locally advanced or metastatic or recurrent RCC; At least one measurable lesion per RECIST 1.1

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Max 2 prior lines

Must have received: PD-(L)1 inhibitor

resistance to previous treatment with PD-(L)1 inhibitor

Cannot have received: Lenvatinib (Lenvatinib)

Subjects who were previously treated with Lenvatinib or who participated in a clinical trial of a generic version of Lenvatinib

Lab requirements

Blood counts

Adequate organ function

Kidney function

Adequate organ function

Liver function

Adequate organ function

Adequate organ function

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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