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

ConditionsSolid Tumors Non-small Cell Lung Cancer Renal Cell Carcinoma Hepatocellular Carcinoma

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

Lenvatinib + Envafolimab
Drug
Lenvatinib will be administered with water orally once a day (with or without food) continuously in 28-day treatment cycle. Envafolimab, 400 mg per dose, subcutaneous injection, dosed on D1 and then D15 of Treatment Cycle 1, and D1 of Treatment Cycle 2 and every subsequent cycles, with every 28 days as one treatment cycle.
Sunitinib
Drug
Sunitinib will be administered with water orally once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off (Schedule 4/2) in 42-day treatment cycle.

Treatment groups

170 Participants

are divided into 6 treatment groups

Treatment groups

See each treatment group below.

Group A: Phase Ib armExperimental treatment 1 intervention

Group B: Phase II cohort1-NSCLCExperimental treatment 1 intervention

Group C: II Phase cohort1-RCCExperimental treatment 1 intervention

Group D: Phase II cohort1-HCCExperimental treatment 1 intervention

Group E: Phase II cohor2-experiment groupExperimental treatment 1 intervention

Group F: Phase II cohort2-control groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

RP2D(Phase Ib)

Recommendation phase II dose

Time frame

first Cycle (28 Days)

Dose Limiting Toxicity (DLT) (Phase Ib)

Number of participants who experience DLT of the first Cycle（28days)

Time frame

first Cycle (28 Days)

objective response rate (ORR) （Phase II）

Defined as the percentage of participants in the analysis population who experienced a Complete Response or a Partial Response and was assessed using RECIST 1.1 based on investigator evaluation.

Time frame

Two years

Secondary outcomes

Objective response rate (ORR) （Phase Ib）

Defined as the percentage of participants in the analysis population who experienced a Complete Response or a Partial Response and was assessed using RECIST 1.1 based on investigator evaluation.

Time frame

Two years

Duration of response (DoR)

Defined as the time from response to documented disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) based on investigator evaluation.

Time frame

Two years

Progression Free Survival (PFS)

Defined as the time from experiment drug administration to documented disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) or death due to any cause, whichever occurred first and was based on investigato evaluation.

Time frame

Two years

Overall Survival (OS)

Defined as the time from experiment drug administration to death due to any cause

Time frame

Two years

Other outcomes

Disease control rate (DCR)

Defined as the percentage of participants in the analysis population who experienced a Complete Response or a Partial Response or stable disease and was assessed using RECIST 1.1 based on investigato evaluation

Time frame

Two years

Time to Response(TTR)

Defined as the time from experiment drug administration to the first date of response was objectively documented

Time frame

Two years

Locations23

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Sponsors and contacts

Click on the lead sponsor to view all of their trials.

3D Medicines (Sichuan) Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

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