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

Launched by 3D MEDICINES (SICHUAN) CO., LTD. · Aug 22, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment combination of two drugs, Envafolimab and Lenvatinib, for patients with advanced solid tumors, including non-small cell lung cancer, kidney cancer, and liver cancer. The goal is to see if this combination is more effective than standard treatments. The trial is currently recruiting participants who are 18 years or older and have tumors that have either progressed after standard treatment or for whom traditional therapies are not appropriate.

To be eligible, participants must have measurable tumors and good overall health, with a life expectancy of at least 12 weeks. They should not have received certain treatments recently or have specific health issues that could complicate the study. Participants will be monitored closely throughout the trial, and they will provide consent before joining. This trial could lead to new treatment options for patients with difficult-to-treat cancers, so it’s an important opportunity for those who qualify.

Gender

ALL

Eligibility 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.