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NCT Number: NCT06746961

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

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

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects participate voluntarily and sign informed consent.
  • 18-75 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

Exclusion criteria

  • 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

Treatment and study plan

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

Drug

5mg/kg , iv, q3w

Lenvatinib

Drug

8 mg or 12 mg QD via oral capsule

Other names: MK-7902, E7080, LENVIMA

Primary outcomes

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

    Time frame: up to ~21 days

    Hematologic DLTs are defined as:

    • Grade 4 neutropenia lasting for ≥7 days
    • febrile neutropenia not associated with the underlying disease,
    • Grade 3 thrombocytopenia with bleeding, Grade ≥3 thrombocytopenia requiring platelet transfusion, Grade 4 thrombocytopenia, .

  2. Phase II: Overall Survival (OS) in all participants

    Time frame: up to ~48 months

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

Secondary outcomes

  1. PFS

    Time frame: up to ~42 months

    PFS is defined as the time from the first administration to the first documented progressive disease (PD) per RECIST 1.1 by investigators or death due to any cause, whichever occurs first.

  2. ORR

    Time frame: up to ~42 months

    ORR is defined as the percentage of participants with Complete Response or Partial Response per RECIST 1.1 assessed by the investigators.

  3. DOR

    Time frame: up to ~42 months

    For participants who demonstrate a confirmed CR or PR, per RECIST 1.1 by the investigators, DOR is defined as the time from first documented evidence of CR or PR until PD or death.

  4. Number of Participants With AEs

    Time frame: Up to ~53 months

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Study contacts

Contact information is provided by the study sponsor or research team.

Professor Wang

CONTACT

[email protected]

+86-0371-66913114

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Zhengzhou University

Other

Registry information

Official study title

A Single-arm, Open-label, Multicenter Phase Ⅰb/Ⅱ Clinical Study of QL1706 (bispecific Antibody Targeting PD-1 and CLTA-4) in Combination with Lenvatinib in Second-line Therapy for Advanced Esophageal Squamous Cell Carcinoma After Disease Progression on Immune Checkpoint Blockades Therapy

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Dec 24, 2024
Registry last updated
Dec 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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