Efficacy and Safety of QL1706 Plus Lenvatinib As 2nd Line Theapy in Patients with Metastatic Esophageal Carcinoma After Disease Progression on ICIs Therapy

NCT06746961 | Not Yet Recruiting Phase 1

• 1 other identifier: QLMA-EC-IIT-001
• Study Type: interventional
• Target: 49
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to assess the efficacy and safety of QL1706 plus lenvatinib in second-line therapy for patients with metastatic esophageal squamous cell carcinoma after progression on immune checkpoint inhibitor therapy

Conditions

Esophageal Squamous Cell Carcinoma (ESCC)

Keywords

QL1706; lenvatinib; immune checkpoint blockades; esophageal squamous cell carcinoma; ESCC

Outcome Measures

Primary Outcomes (2)

• Phase Ib：Dose Limiting Toxicities (DLTs) and recommended phase 2 dose (PR2D)

  Hematologic DLTs are defined as: 1. Grade 4 neutropenia lasting for ≥7 days 2. febrile neutropenia not associated with the underlying disease, 3. Grade 3 thrombocytopenia with bleeding, Grade ≥3 thrombocytopenia requiring platelet transfusion, Grade 4 thrombocytopenia, .

  up to ~21 days

• Phase II: Overall Survival (OS) in all participants

  OS is defined as the time from the first administration to death due to any cause.

  up to ~48 months

Secondary Outcomes (4)

• PFS

  up to ~42 months

• ORR

  up to ~42 months

• DOR

  up to ~42 months

• Number of Participants With AEs

  Up to ~53 months

Study Arms (1)

QL1706 plus Lenvatinib

EXPERIMENTAL

QL1706 will be administrated at a dose of 5 mg/kg intravenously (IV), every 3 weeks, until progressive disease or intolerable or other reasons according to the criteria for termination of treatment. QL1706 will be administrated up to 2 year. Lenvatinib will be administrated at a dose of 8 mg or 12mg orally (PO) once daily (QD)

Drug: QL1706 (bispecific antibody targeting PD-1 and CLTA-4); Drug: Lenvatinib

Interventions

QL1706 (bispecific antibody targeting PD-1 and CLTA-4) DRUG

5mg/kg , iv, q3w

QL1706 plus Lenvatinib

Lenvatinib DRUG

8 mg or 12 mg QD via oral capsule

Also known as: MK-7902, E7080, LENVIMA

QL1706 plus Lenvatinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects participate voluntarily and sign informed consent.
• years, male or female.
• Histologically or cytologically verified diagnosis of unresectable locally advanced or metastatic esophageal squamous cell carcinoma
• Patients who have disease progression verified by imaging on standard first-line immunotherapy with anti-PD-1/PD-L1 antibodies
• At least 1 measurable target lesion according to Response Evaluation in Solid Tumors (RECIST 1.1).
• ECOG PS 0-1

You may not qualify if:

• Presence of any active autoimmune disease or history of autoimmune disease (such as: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, nephritis, hyperthyroidism)
• Those who are taking immunosuppressants or systemic hormonal therapy for immunosuppressive purposes (dose\> 10 mg/day prednisone or other equivalent cortiremonial hormones) and are taking within 2 weeks before recruitment
• Severe allergic reaction to other monoclonal antibodies
• Those who terminated treatment due to related toxicity during anti-PD-1/PD-L1 antibody treatment
• Prior treatment with bispecific anti-PD-1/CTLA-4 checkpoint blockades or VEGFR inhibitors

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University: lead

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

lenvatinib

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Central Study Contacts

Professor Wang

CONTACT

+86-0371-66913114; zzuwangfeng@zzu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: December 24, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: December 24, 2024

Record last verified: 2024-11