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.
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
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma (ESCC)
- What is being tested?
- QL1706 (bispecific antibody targeting PD-1 and CLTA-4) and Lenvatinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- 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
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.
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 group | Role | What they receive |
|---|---|---|
| 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) 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.
Phase Ib：Dose Limiting Toxicities (DLTs) and recommended phase 2 dose (PR2D)
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, .
Measured: 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.
Measured: up to ~48 months
Secondary outcomes (4)
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
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
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
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.
- First posted24 Dec 2024
- Study startJan 2025 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell Carcinoma (ESCC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng Wang, The First Affiliated Hospital of Zhengzhou University
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