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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QL1706 (bispecific antibody targeting PD-1 and CLTA-4) | Drug | 5mg/kg , iv, q3w |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Phase Ib:Dose Limiting Toxicities (DLTs) and recommended phase 2 dose (PR2D) | Hematologic DLTs are defined as:
| 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. | up to ~48 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to ~42 months |
| ORR |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Professor Wang | Contact | +86-0371-66913114 | zzuwangfeng@zzu.edu.cn |
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| Lenvatinib |
| Drug |
8 mg or 12 mg QD via oral capsule |
|
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ORR is defined as the percentage of participants with Complete Response or Partial Response per RECIST 1.1 assessed by the investigators.
| 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. | 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. | Up to ~53 months |
| ID | Term |
|---|---|
| D000077277 | Esophageal Squamous Cell Carcinoma |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D004938 | Esophageal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| C531958 | lenvatinib |
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