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

This 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.

Trial Details

NCT ID

NCT05024214

Phase

PHASE1 / PHASE2

Sponsor

3D Medicines (Sichuan) Co., Ltd.

Status

RECRUITING

Cancer Type

Kidney Cancer

Interventions

Lenvatinib + Envafolimab
Sunitinib

Locations (sample)

Bengbu, Anhui, China|32.94083,117.36083
Beijing, Beijing Municipality, China|39.9075,116.39723
Beijing, Beijing Municipality, China|39.9075,116.39723
Fuzhou, Fujian, China|26.06139,119.30611
Xiamen, Fujian, China|24.47979,118.08187

Key Eligibility Criteria

Eighteen years and older;
phase Ib:Histological or cytological diagnosis of Locally advanced or metastatic solid tumors (excluding hepatocellular carcinoma and thyroid carci…
phase II cohort 1:Histological or cytological diagnosis of NSCLC，RCC, HCC, resistance to previous treatment with PD-(L)1 inhibitor; previous system…
phase II cohort 2：Unresectable locally advanced or metastatic or recurrent RCC;

For full eligibility, visit ClinicalTrials.gov.

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