A Study of QLS31905 Combination Chemotherapy as First-Line Treatment in Patients With Advanced Solid Tumors
NCT ID: NCT06041035
Last Updated: 2023-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1/PHASE2
115 participants
INTERVENTIONAL
2023-10-31
2025-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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QLS31905 + nab-paclitaxel + gemcitabine (Part A/B)
Pancreatic cancer participants will be treated with QLS31905 in combination with nab-paclitaxel and gemcitabine for part A of the study to establish the recommended dose of QLS31905 for part B. In part B, the participants will be treated with QLS31905 at a dose determined by the part A of the study in combination with nab-paclitaxel and gemcitabine.
QLS31905
Administered as an intravenous infusion.
Nab paclitaxel
125 mg/m2 administered as IV infusion on D1/D8/D15 of each cycle.
Gemcitabine
1000 mg/m2 administered as IV infusion on D1/D8/D15 of each cycle.
QLS31905 + oxaliplatin + capecitabine (Part B)
In part B, gastric/gastroesophageal junction cancer participants will be treated with QLS31905 at dose determined by part A of the study in combination with oxaliplatin and capecitabine.
QLS31905
Administered as an intravenous infusion.
Oxaliplatin
85 mg/m2, intravenous infusion, D1/D15, up to 6 cycles.
Capecitabine
1000 mg/m2, oral, bid, D1-D7,D15-D21, up to 6 cycles.
QLS31905 + gemcitabine+cisplatin(Part B)
In part B, other solid tumor participants including but not limited to biliary tract cancer will be treated with QLS31905 at dose determined by part A in combination with standard chemotherapy recommended by guidelines.QLS31905 plus gemcitabine+ cisplatin as the first-line treatment of advanced biliary tract cancer.
QLS31905
Administered as an intravenous infusion.
Gemcitabine
1000 mg/m2 administered as IV infusion on D1/D8/D15 of each cycle.
Cisplatin
25 mg/m2, intravenous infusion, D1/D15, up to 6 cycles.
Interventions
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QLS31905
Administered as an intravenous infusion.
Nab paclitaxel
125 mg/m2 administered as IV infusion on D1/D8/D15 of each cycle.
Gemcitabine
1000 mg/m2 administered as IV infusion on D1/D8/D15 of each cycle.
Oxaliplatin
85 mg/m2, intravenous infusion, D1/D15, up to 6 cycles.
Capecitabine
1000 mg/m2, oral, bid, D1-D7,D15-D21, up to 6 cycles.
Cisplatin
25 mg/m2, intravenous infusion, D1/D15, up to 6 cycles.
Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
* Expected survival time ≥ 3 months;
* Histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumors;
* No prior systemic anti-tumor treatment for locally advanced unresectable or metastatic disease;
* Tumor tissue samples determined to have moderate-to-high Claudin18.2 expression by immunohistochemistry (IHC);
* At least one measurable lesion per RECIST v1.1;
* Patients with adequate cardiac, liver, renal function, etc.
Exclusion Criteria
* Underwent major organ surgery (excluding needle biopsy) or had significant trauma within 28 days prior to enrollment, or requires elective surgery during the study;
* Known central nervous system metastases;
* Patients with hepatitis B; patients with hepatitis C; patients who test positive for syphilis, or patients with a known history of HIV or positive HIV screening test;
* Patients with a known history of psychoactive drug abuse, alcohol abuse, or substance abuse;
* Patients with added risks associated with the study or may interfere with the interpretation of study results as determined by the investigator, or deemed unsuitable by the investigator and/or sponsor.
18 Years
ALL
No
Sponsors
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Qilu Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Other Identifiers
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QLS31905-201
Identifier Type: -
Identifier Source: org_study_id
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