A Phase 1/2 interventional study of QL1706 (bispecific antibody targeting PD-1 and CLTA-4) and Lenvatinib in Esophageal Squamous Cell Carcinoma (ESCC), sponsored by The First Affiliated Hospital of Zhengzhou University. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-12-24.
Sponsored by The First Affiliated Hospital of Zhengzhou University · Phase 1/2, Interventional, and Treatment
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
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's planned enrollment of 49 is close to the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →The First Affiliated Hospital of Zhengzhou University is the lead sponsor of 123 studies on the registry; 72 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
5mg/kg , iv, q3w
8 mg or 12 mg QD via oral capsule
Also known as: MK-7902, E7080, LENVIMA
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, .
Time frame: 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.
Time frame: up to ~48 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to ~53 months
No study locations are listed for this record.
This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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The First Affiliated Hospital of Zhengzhou University