Study of QLS31905 and/or QL1706 Combination With Chemotherapy in the Advanced Malignant Solid Tumors
NCT ID: NCT06446388
Last Updated: 2024-06-06
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
PHASE2
360 participants
INTERVENTIONAL
2024-06-30
2027-12-01
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 + oxaliplatin + capecitabine
Gastric/gastroesophageal junction cancer participants will be treated with QLS31905 at doses determined by the phase I study in combination with oxaliplatin and capecitabine.
QLS31905
Administered as an intravenous infusion.
Oxaliplatin
130 mg/m2, intravenous infusion, D1, up to 8 cycles.
Capecitabine
1000 mg/m2, oral, bid, D1-D14
QL1706 + oxaliplatin + capecitabine
Gastric/gastroesophageal junction cancer participants will be treated with QL1706 in combination with oxaliplatin and capecitabine.
Oxaliplatin
130 mg/m2, intravenous infusion, D1, up to 8 cycles.
Capecitabine
1000 mg/m2, oral, bid, D1-D14
QL1706
5 mg/kg, intravenous infusion,D1
QLS31905 + oxaliplatin + capecitabine + QL1706
Gastric/gastroesophageal junction cancer participants will be treated with QLS31905 at doses determined by the phase I study in combination with oxaliplatin and capecitabine+ QL1706.
QLS31905
Administered as an intravenous infusion.
Oxaliplatin
130 mg/m2, intravenous infusion, D1, up to 8 cycles.
Capecitabine
1000 mg/m2, oral, bid, D1-D14
QL1706
5 mg/kg, intravenous infusion,D1
QLS31905 + gemcitabine+cisplatin
Biliary tract cancer will be treated with QLS31905 at doses determined by the phase I study in combination with gemcitabine and cisplatin.
QLS31905
Administered as an intravenous infusion.
Gemcitabine
1000 mg/m2 administered as IV infusion on D1/D8 of each cycle.
Cisplatin
25 mg/m2, intravenous infusion, D1/D8, up to 8 cycles.
QL1706 + gemcitabine+cisplatin
Biliary tract cancer will be treated with QL1706 in combination with gemcitabine and cisplatin.
Gemcitabine
1000 mg/m2 administered as IV infusion on D1/D8 of each cycle.
Cisplatin
25 mg/m2, intravenous infusion, D1/D8, up to 8 cycles.
QL1706
5 mg/kg, intravenous infusion,D1
QLS31905 + gemcitabine+cisplatin+ QL1706
Biliary tract cancer will be treated with QLS31905 at doses determined by the phase I study in combination with gemcitabine and cisplatin+ QL1706.
QLS31905
Administered as an intravenous infusion.
Gemcitabine
1000 mg/m2 administered as IV infusion on D1/D8 of each cycle.
Cisplatin
25 mg/m2, intravenous infusion, D1/D8, up to 8 cycles.
QL1706
5 mg/kg, intravenous infusion,D1
QLS31905 + standard chemotherapy
Other solid tumor participants will be treated with QLS31905 at doses determined by the phase I study in combination with standard chemotherapy recommended by guidelines.
QLS31905
Administered as an intravenous infusion.
Chemotherapy drug
Standard chemotherapy recommended by guidelines.
QL1706 + standard chemotherapy
Other solid tumor participants will be treated with QL1706 in combination with standard chemotherapy recommended by guidelines.
QL1706
5 mg/kg, intravenous infusion,D1
Chemotherapy drug
Standard chemotherapy recommended by guidelines.
QLS31905 + standard chemotherapy + QL1706
Other solid tumor participants will be treated with QLS31905 at doses determined by the phase I study in combination with standard chemotherapy and QL1706.
QLS31905
Administered as an intravenous infusion.
QL1706
5 mg/kg, intravenous infusion,D1
Chemotherapy drug
Standard chemotherapy recommended by guidelines.
Interventions
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QLS31905
Administered as an intravenous infusion.
Oxaliplatin
130 mg/m2, intravenous infusion, D1, up to 8 cycles.
Capecitabine
1000 mg/m2, oral, bid, D1-D14
Gemcitabine
1000 mg/m2 administered as IV infusion on D1/D8 of each cycle.
Cisplatin
25 mg/m2, intravenous infusion, D1/D8, up to 8 cycles.
QL1706
5 mg/kg, intravenous infusion,D1
Chemotherapy drug
Standard chemotherapy recommended by guidelines.
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 be positive for Claudin18.2 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
75 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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Facility Contacts
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Other Identifiers
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QLS31905-202
Identifier Type: -
Identifier Source: org_study_id
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