Phase Ib/II Trial of Envafolimab Plus Lenvatinib for Subjects With Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
Sponsor3D Medicines (Sichuan) Co., Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
Eighteen years and older;
phase Ib:Histological or cytological diagnosis of Locally advanced or metastatic solid tumors (excluding hepatocellular carcinoma and thyroid carcinoma) that have progressed after standard treatment or are intolerant or have no effective treatment;
phase II cohort 1:Histological or cytological diagnosis of NSCLC，RCC, HCC, resistance to previous treatment with PD-(L)1 inhibitor; previous system treatment lines≤2;
phase II cohort 2：Unresectable locally advanced or metastatic or recurrent RCC;
Disqualifiers
Prior anticancer treatment within 4 weeks prior to the first dose of study drugs;
Toxicity from prior anticancer therapy prior to the first dose of study drugs not recovered to ≤ grade1;
Hypertension did not satisfactory controlled after antihypertensive medication
Phase Ib/II: Subjects who were previously treated with Lenvatinib or who participated in a clinical trial of a generic version of Lenvatinib
Trial design
Treatments tested in this trial
- Lenvatinib + Envafolimab
- Sunitinib
Treatment groups
170 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov