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The study aims to evaluate the efficacy and safety of the QL1706 combination with paclitaxel and bevacizumab in patients with gastric adenocarcinoma and gastroesophageal junction adenocarcinoma who have failed first-line standard therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QL1706 combined with paclitaxel and bevacizumab | Experimental | QL1706 7.5 or 5 mgmg/kg combined with paclitaxel 150 mg/m2 and bevacizumab 7.5mg/kg, d1, Q3W |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QL1706 combined with paclitaxel and bevacizumab | Drug | Phase 1: Plan to enroll 6 subjects to receive QL1706 7.5 mg/kg, paclitaxel 150 mg/m², and bevacizumab 7.5 mg/kg, d1, Q3W. Subjects will undergo a 3-week Dose-Limiting Toxicity (DLT) evaluation period. If ≥2 DLTs occur among the 6 subjects, QL1706 5 mg/kg will be selected as the Recommended Phase 2 Dose (RP2D) for Phase 2. Otherwise, QL1706 7.5 mg/kg will be the RP2D for Phase 2. Phase 2: Plan to enroll 54-60 subjects. Starting from Cycle 1, QL1706 will be administered intravenously at the RP2D determined in Phase 1. Subjects will receive: QL1706 (RP2D) Paclitaxel 150 mg/m² Bevacizumab 7.5 mg/kg All agents administered on day 1 of each Q3W cycle. Treatment Duration for All Subjects: Continues until disease progression, intolerable toxicity, withdrawal of informed consent, death, or initiation of new antitumor therapy-whichever occurs first. |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | The time from the initiation of the first dose to the occurrence of disease progression or death, whichever comes first. | up to 7 months |
| Dose-limiting toxicity | Within Cycle 1 (21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| OS | The time interval between the start date of study drug and the date of death (any cause) | up to 13 months |
| DoR | monitor the length of time patients experience a reduction in tumor size or stabilization of disease following the treatment |
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Inclusion Criteria:
Signed written informed consent and voluntarily enrolled in the study.
Aged 18-75 years, regardless of gender.
Histologically or cytologically confirmed unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.
Documented failure after ≥3 cycles of prior first-line PD-(L)1 inhibitor combined with fluorouracil-based or platinum-based chemotherapy.
*Note: Disease recurrence/progression ≤6 months after completing (neo)adjuvant systemic therapy qualifies as first-line treatment.*
HER2-negative status (IHC 0/1+ or IHC 2+/FISH-negative).
ECOG Performance Status 0-1.
≥1 measurable lesion per RECIST v1.1. Previously irradiated lesions cannot be target lesions unless: the irradiated lesion is the sole measurable lesion and documented progression in the irradiated lesion by imaging
Life expectancy ≥3 months.
Adequate organ function:
Hematology (no blood products/growth factors within 14 days prior):
Biochemistry:
Coagulation:
Reproductive requirements:
Willingness to comply with protocol-specified follow-up procedures.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jia wei | Contact | 0086-025-83304616 | jiawei99@nju.edu.cn |
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|
| up to 6 months |
| ORR | the proportion of subjects achieving complete response (CR) or partial response (PR) | up to 7 months |
| AE | Number and percentage of participants with Adverse Events(any grade) | the first dose until 90 days after the last dose of QL1706 or 30 days after the last dose of other study drugs, whichever comes later. |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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