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Combining Envafolimab and Lenvatinib for treating advanced solid tumors

Envafolimab(KN035) in Combination With Lenvatinib in the Treatment of Advanced Solid Tumors: a Multicenter, Open-label, Phase Ib/II Study

Phase1; Phase2 Interventional 3D Medicines · NCT05024214

This study is testing if combining two drugs, Envafolimab and Lenvatinib, can help people with advanced solid tumors feel better when other treatments haven't worked.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment170 (estimated)
Ages18 Years and up
SexAll
Sponsor3D Medicines Industry-sponsored
Drugs / interventionsLenvatinib, Sunitinib, chemotherapy, prednisone, Envafolimab
Locations23 sites (Bengbu, Anhui and 22 other locations)
Trial IDNCT05024214 on ClinicalTrials.gov

What this trial studies

This open-label, multi-center Phase Ib/II trial evaluates the safety and efficacy of combining Envafolimab with Lenvatinib in patients with advanced solid tumors, including non-small cell lung cancer, renal cell carcinoma, and hepatocellular carcinoma. The study aims to determine if this combination can achieve a better objective response rate compared to standard of care treatments. Eligible participants must have progressed after standard treatments or have no effective options available. The trial includes both a Phase Ib and a Phase II cohort with specific inclusion criteria for each.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with advanced solid tumors that have progressed after standard treatments or are intolerant to them.

Not a fit: Patients with solid tumors that are not locally advanced or metastatic, or those who have not progressed after standard treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment combination could provide a new effective option for patients with advanced solid tumors who have limited treatment alternatives.

How similar studies have performed: Other studies have explored similar combinations of immunotherapy and targeted therapy, showing promising results, but this specific combination is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Eighteen years and older;
2. 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;
3. 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;
4. phase II cohort 2：Unresectable locally advanced or metastatic or recurrent RCC;
5. 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 adjuvant/neoadjuvant chemotherapy are allowed;
6. 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；
7. Life expectancy of at least 12 weeks;
8. At least one measurable lesion per RECIST 1.1;
9. Adequate organ function;
10. Signed informed consent.

Exclusion Criteria:

1. Prior anticancer treatment within 4 weeks prior to the first dose of study drugs;
2. Toxicity from prior anticancer therapy prior to the first dose of study drugs not recovered to ≤ grade1;
3. Hypertension did not satisfactory controlled after antihypertensive medication
4. Phase Ib/II: Subjects who were previously treated with Lenvatinib or who participated in a clinical trial of a generic version of Lenvatinib
5. 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;
6. Uncontrollable or significant cardiovascular or cerebrovascular disease;
7. Active, known history or suspected autoimmune disease;
8. 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;
9. 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;
10. Subjects with known or suspected interstitial pneumonia;
11. 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 immunodeficiency syndrome (AIDS)
12. Active hepatitis B or hepatitis C;
13. Known history of severe gastrointestinal bleeding or active hemoptysis or other severe bleeding within 6 months prior to first study drug therapy;
14. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage ;
15. Known active or symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis;
16. Have other primary malignancies within 5 years;
17. Known history of contraindications or hypersensitivity reactions to any investigational drug component or any known excipients
18. Women who are pregnant or breastfeeding.
19. Radiographic evidence of major blood vessel invasion/infiltration may be considered for enrollment if the investigator assesses that the risk is manageable.

Where this trial is running

Bengbu, Anhui and 22 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Solid TumorsNon-small Cell Lung CancerRenal Cell CarcinomaHepatocellular Carcinoma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.