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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
49
5mg/kg , iv, q3w
8 mg or 12 mg QD via oral capsule
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
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