Actively Recruiting
Phase Ib/II Trial of Envafolimab Plus Lenvatinib for Subjects With Solid Tumors
Led by 3D Medicines (Sichuan) Co., Ltd. · Updated on 2026-03-25
170
Participants Needed
23
Research Sites
263 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase Ib/II Trial of Envafolimab Plus Lenvatinib for Subjects With Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 with resistance to previous PD-(L)1 inhibitor treatment; no more than 2 prior systemic treatment lines
- Phase II cohort 2: Unresectable locally advanced, metastatic, or recurrent RCC
- Tumor tissue samples or biopsies from archived or fresh biopsies with locally advanced/metastatic disease must be provided; samples prior to adjuvant/neoadjuvant chemotherapy allowed if biopsies unavailable
- Phase Ib and phase II cohort 1: ECOG Performance Status of 0 or 1; Phase II cohort 2: Karnofsky physical status (KPS) score 70
- Life expectancy of at least 12 weeks
- At least one measurable lesion per RECIST 1.1
- Adequate organ function
- Signed informed consent
You will not qualify if you...
- Prior anticancer treatment within 4 weeks before first dose of study drugs
- Toxicity from prior anticancer therapy not recovered to grade 1 or less
- Hypertension not satisfactorily controlled after antihypertensive medication
- Prior treatment with Lenvatinib or participation in clinical trial of generic Lenvatinib
- Phase II cohort 1: Intolerance to PD-(L)1 inhibitor; history of severe digestive disease affecting oral absorption of Lenvatinib/Sunitinib
- Uncontrollable or significant cardiovascular or cerebrovascular disease
- Active, known history, or suspected autoimmune disease
- Use or requirement of >10 mg/day prednisone or equivalent corticosteroids within 14 days before first dose
- Receipt of live attenuated vaccine within 28 days before first dose or planned during study
- Known or suspected interstitial pneumonia
- Serious active infection requiring systemic therapy, including active tuberculosis; known HIV/AIDS
- Active hepatitis B or C
- History of severe gastrointestinal bleeding, active hemoptysis, or severe bleeding within 6 months prior to first study drug
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage
- Active or symptomatic CNS metastases or carcinomatous meningitis
- Other primary malignancies within 5 years
- Known contraindications or hypersensitivity to investigational drug components or excipients
- Women who are pregnant or breastfeeding
- Radiographic evidence of major blood vessel invasion/infiltration unless investigator assesses manageable risk
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 23 locations
1
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China, 233004
Actively Recruiting
2
The Seventh Medical Center of the PLA General Hospital
Beijing, Beijing Municipality, China, 100700
Actively Recruiting
3
Beijing Hospital
Beijing, Beijing Municipality, China, 100730
Not Yet Recruiting
4
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
Not Yet Recruiting
5
Zhongshan Hospital,Fudan University(Xiamen Branch)
Xiamen, Fujian, China, 361015
Not Yet Recruiting
6
Dongguan People's Hospital
Dongguan, Guangdong, China, 523059
Actively Recruiting
7
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510280
Actively Recruiting
8
The Fifth Affiliated Hospital Sun Yat-Sen University
Zhuhai, Guangdong, China, 519000
Actively Recruiting
9
Harbin Medical University Cancer Hospital
Haerbin, Heilongjiang, China, 150081
Not Yet Recruiting
10
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Actively Recruiting
11
The Second Affiliater Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Not Yet Recruiting
12
THE First Hospital of Jilin University
Changchun, Jilin, China, 130012
Not Yet Recruiting
13
Jilin Cancer Hospital
Changchun, Jilin, China, 130028
Not Yet Recruiting
14
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China, 116011
Actively Recruiting
15
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China, 110001
Actively Recruiting
16
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, China, 110011
Actively Recruiting
17
The 960th Hospital of the PLA Joint Logistics Support Force
Jinan, Shandong, China, 250031
Actively Recruiting
18
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China, 030001
Actively Recruiting
19
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
20
The Cancer Affiliated Hospital of Xinjiang Medical College
Ürümqi, Xinjiang, China, 830011
Actively Recruiting
21
Yunnan Cancer Hospital
Kunming, Yunnan, China, 650118
Actively Recruiting
22
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310020
Actively Recruiting
23
Fudan University
Shanghai, China
Actively Recruiting
Research Team
S
siying xu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
6
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