Phase II Study of QL1706 Combined With Paclitaxel and Bevacizumab for Second-Line Immune Rechallenge in Gastric Cancer

NCT07045805 | Not Yet Recruiting Phase 2

• 1 other identifier: QL-GasC-QIBA-1002
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Gastric Cancer (GC)

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (4)

• OS

  up to 13 months

• DoR

  up to 6 months

• ORR

  up to 7 months

• AE

  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.

Study Arms (1)

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

Drug: QL1706 combined with paclitaxel and bevacizumab

Interventions

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.

QL1706 combined with paclitaxel and bevacizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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):
• Absolute neutrophil count ≥1.0×10⁹/L
• Platelets ≥75×10⁹/L
• Hemoglobin ≥90 g/L
• Biochemistry:

You may not qualify if:

• Histopathological or cytological examination confirms the presence of other pathological components, such as squamous cell carcinoma, undifferentiated carcinoma, neuroendocrine carcinoma, etc.
• Previous systemic treatment targeting VEGF or the anti-VEGFR signaling pathway.
• Previous treatment with PD-1/CTLA-4 dual immunotherapy.
• Previous systemic or local treatment with paclitaxel-based drugs.
• Received the last anti-tumor therapy within 5 half-lives (whichever is shorter) prior to the first dose, including chemotherapy, immunotherapy, targeted therapy (within 2 weeks prior to the first dose for small molecule targeted therapy), biological therapy, etc.; Palliative local therapy for non-target lesions within 2 weeks prior to the first dose; Received systemic non-specific immunomodulatory therapy (e.g., interleukin, interferon, thymosin) within 2 weeks prior to the first dose.
• History of Grade 3 or higher irAEs (excluding endocrine system-related irAEs) caused by PD-1/PD-L1 inhibitors.
• Permanent discontinuation of previous treatment due to irAEs.
• Has not adequately recovered (i.e., ≤ Grade 1 or returned to baseline, excluding fatigue or alopecia) from toxicities and/or complications caused by any prior intervention prior to starting treatment.
• Presence of clinically symptomatic pleural effusion, pericardial effusion, or ascites requiring frequent drainage (≥1 time/month).
• Known active or untreated brain metastases, leptomeningeal metastases, spinal cord compression, or leptomeningeal disease. However, subjects with measurable disease outside the central nervous system who meet the following criteria may be enrolled: asymptomatic after treatment, radiologically stable for at least 4 weeks prior to initiation of study treatment (e.g., no new or enlarging brain metastases), and off systemic glucocorticoids and anticonvulsants for at least 2 weeks.
• History of gastrointestinal perforation, gastrointestinal fistula, or intra-abdominal abscess within 6 months prior to the first dose.
• History of bowel obstruction and/or clinical signs or symptoms of gastrointestinal obstruction within 6 months prior to the first dose, including incomplete obstruction related to the underlying disease or requiring routine parenteral hydration, parenteral nutrition, or tube feeding.
• Significant clinically significant bleeding symptoms or definite bleeding tendency within 6 months prior to the first dose, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, or vasculitis, etc., excluding asymptomatic occult blood-positive stool.
• Tumor invasion of major blood vessels, or investigator judgment based on imaging that tumor invasion of major blood vessels is highly likely during the future study period, potentially leading to fatal hemorrhage.
• Arterial or venous thromboembolic events within 6 months prior to the first dose, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism, etc. (superficial venous thrombosis is allowed).

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Paclitaxel; Bevacizumab

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Jia wei

CONTACT

0086-025-83304616; jiawei99@nju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 1, 2025
• Study Start: July 25, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share