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New treatment option for Solid Tumors
Official title Phase Ib/II Trial of Envafolimab Plus Lenvatinib for Subjects With Solid Tumors
ClinicalTrials.gov ID: NCT05024214
What this study is testing
What is Lenvatinib + Envafolimab?
Lenvatinib + Envafolimab is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Eighteen years and older;
- phase Ib:Histological or cytological diagnosis of Locally advanced or metastatic solid tumors (excluding hepatocellular carcinoma and thyroid...
- 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;
- Tumor tissue samples or biopsies from FFPE archived or fresh biopsies with locally advanced/metastatic disease must be provided, and if biopsies are...
You likely can't join if
- 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: people who were previously treated with Lenvatinib or who participated in a clinical trial of a generic version of Lenvatinib
- Phase II cohort 1, intolerance to treatment with A PD-(L)1 inhibitor; History of severe digestive disease that can affect the oral absorption of...
- Uncontrollable or significant cardiovascular or cerebrovascular disease;
See the full eligibility criteria
- 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...
- 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;
- Tumor tissue samples or biopsies from FFPE archived or fresh biopsies with locally advanced/metastatic disease must be provided, and if biopsies are not available, samples obtained prior to receiving...
- phase Ib and phase II cohort 1: Eastern Cooperative Oncology Group(ECOG) Performance Status of 0 or 1; Phase II cohort 2: Karnofsky physical status (KPS) assessment ≥70；
- Life expectancy of at least 12 weeks;
- At least one measurable lesion per RECIST 1.1;
- Adequate organ function;
- Signed informed consent.
- 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: people who were previously treated with Lenvatinib or who participated in a clinical trial of a generic version of Lenvatinib
- Phase II cohort 1, intolerance to treatment with A PD-(L)1 inhibitor; History of severe digestive disease that can affect the oral absorption of Lenvatinib/Sunitinib;
- Uncontrollable or significant cardiovascular or cerebrovascular disease;
- Active, known history or suspected autoimmune disease;
- Have used or require treatment with \>10 mg/day of prednisone or an equivalent dose of systemic corticosteroids within 14 days prior to the first dose of study drugs;
- have received live attenuated vaccine within 28 days prior to the first study drug treatment or are scheduled to receive it during the study period;
- people with known or suspected interstitial pneumonia;
- Any serious active infection requiring systemic antibacterial, antifungal or antiviral therapy at screening, including active tuberculosis; Known history of human immunodeficiency virus (HIV) infection or acquired...
- Active hepatitis B or hepatitis C;
- Known history of severe gastrointestinal bleeding or active hemoptysis or other severe bleeding within 6 months prior to first study drug therapy;
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage ;
- Known active or symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis;
- Have other primary malignancies within 5 years;
- Known history of contraindications or hypersensitivity reactions to any investigational drug component or any known excipients
- Women who are pregnant or breastfeeding.
- Radiographic evidence of major blood vessel invasion/infiltration may be considered for enrollment if the investigator assesses that the risk is manageable.
The study team makes the final eligibility decision.
Where it's taking place
- Bengbu, Anhui, China
- Beijing, Beijing Municipality, China
- Fuzhou, Fujian, China
- Xiamen, Fujian, China
- Dongguan, Guangdong, China
- Guangzhou, Guangdong, China
- Zhuhai, Guangdong, China
- Haerbin, Heilongjiang, China
- Zhengzhou, Henan, China
- Nanchang, Jiangxi, China
- Changchun, Jilin, China
- Dalian, Liaoning, China
- Shenyang, Liaoning, China
- Jinan, Shandong, China
- Taiyuan, Shanxi, China
- Tianjin, Tianjin Municipality, China
- Ürümqi, Xinjiang, China
- Kunming, Yunnan, China
- Hangzhou, Zhejiang, China
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bengbu, Anhui, China; Beijing, Beijing Municipality, China; Fuzhou, Fujian, China; Xiamen, Fujian, China; Dongguan, Guangdong, China; Guangzhou, Guangdong, China and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.