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Esophageal Squamous Cell Carcinoma (ESCC)Phase 1/2NCT06746961

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

A Phase 1/2 study testing QL1706 (bispecific antibody targeting PD-1 and CLTA-4) and Lenvatinib in people with Esophageal Squamous Cell Carcinoma (ESCC), run by The First Affiliated Hospital of Zhengzhou University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
QL1706 (bispecific antibody targeting PD-1 and CLTA-4) and Lenvatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
No sites listed yet
Study dates
Jan 2025to Aug 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Professor Wang contact

+86-0371-66913114

zzuwangfeng@zzu.edu.cn

About this study

Official 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

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

Being tested
QL1706 (bispecific antibody targeting PD-1 and CLTA-4), Lenvatinib
Keywords
QL1706, lenvatinib, immune checkpoint blockades, esophageal squamous cell carcinoma, ESCC
Medical subject headings
Esophageal Squamous Cell Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    5mg/kg , iv, q3w

  • LenvatinibDrug

    Also called MK-7902, E7080, LENVIMA

    8 mg or 12 mg QD via oral capsule

Study groups in NCT06746961
Study groupRoleWhat they receive
QL1706 plus LenvatinibExperimentalQL1706 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)
Receives: Drug: QL1706 (bispecific antibody targeting PD-1 and CLTA-4); Drug: Lenvatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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, .

    Measured: up to ~21 days

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

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

    Measured: up to ~48 months

Secondary outcomes (4)

  1. PFS

    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.

    Measured: up to ~42 months

  2. ORR

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

    Measured: up to ~42 months

  3. DOR

    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.

    Measured: up to ~42 months

  4. Number of Participants With AEs

    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.

    Measured: Up to ~53 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2024
  2. Study startJan 2025 (estimated)
  3. Primary completionJul 2026 (estimated)
  4. Study completionAug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
49 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06746961
Sponsor's protocol ID
QLMA-EC-IIT-001
Status last verified
Nov 2024
First submitted
19 Dec 2024
Last updated
24 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing QL1706 (bispecific antibody targeting PD-1 and CLTA-4) and Lenvatinib in people with Esophageal Squamous Cell Carcinoma (ESCC), run by The First Affiliated Hospital of Zhengzhou University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Professor Wang (+86-0371-66913114, zzuwangfeng@zzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase Ib：Dose Limiting Toxicities (DLTs) and recommended phase 2 dose (PR2D) (time frame: up to ~21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06746961.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024.

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