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Trial Title:
Study of QLS31905 and/or QL1706 Combination With Chemotherapy in the Advanced Malignant Solid Tumors
NCT ID:
NCT06446388
Condition:
Advanced Solid Tumor
Conditions: Official terms:
Neoplasms
Gemcitabine
Capecitabine
Oxaliplatin
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
QLS31905
Description:
Administered as an intravenous infusion.
Arm group label:
QLS31905 + gemcitabine+cisplatin
Arm group label:
QLS31905 + gemcitabine+cisplatin+ QL1706
Arm group label:
QLS31905 + oxaliplatin + capecitabine
Arm group label:
QLS31905 + oxaliplatin + capecitabine + QL1706
Arm group label:
QLS31905 + standard chemotherapy
Arm group label:
QLS31905 + standard chemotherapy + QL1706
Intervention type:
Drug
Intervention name:
Oxaliplatin
Description:
130 mg/m2, intravenous infusion, D1, up to 8 cycles.
Arm group label:
QL1706 + oxaliplatin + capecitabine
Arm group label:
QLS31905 + oxaliplatin + capecitabine
Arm group label:
QLS31905 + oxaliplatin + capecitabine + QL1706
Intervention type:
Drug
Intervention name:
Capecitabine
Description:
1000 mg/m2, oral, bid, D1-D14
Arm group label:
QL1706 + oxaliplatin + capecitabine
Arm group label:
QLS31905 + oxaliplatin + capecitabine
Arm group label:
QLS31905 + oxaliplatin + capecitabine + QL1706
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
1000 mg/m2 administered as IV infusion on D1/D8 of each cycle.
Arm group label:
QL1706 + gemcitabine+cisplatin
Arm group label:
QLS31905 + gemcitabine+cisplatin
Arm group label:
QLS31905 + gemcitabine+cisplatin+ QL1706
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
25 mg/m2, intravenous infusion, D1/D8, up to 8 cycles.
Arm group label:
QL1706 + gemcitabine+cisplatin
Arm group label:
QLS31905 + gemcitabine+cisplatin
Arm group label:
QLS31905 + gemcitabine+cisplatin+ QL1706
Intervention type:
Drug
Intervention name:
QL1706
Description:
5 mg/kg, intravenous infusion,D1
Arm group label:
QL1706 + gemcitabine+cisplatin
Arm group label:
QL1706 + oxaliplatin + capecitabine
Arm group label:
QL1706 + standard chemotherapy
Arm group label:
QLS31905 + gemcitabine+cisplatin+ QL1706
Arm group label:
QLS31905 + oxaliplatin + capecitabine + QL1706
Arm group label:
QLS31905 + standard chemotherapy + QL1706
Intervention type:
Drug
Intervention name:
Chemotherapy drug
Description:
Standard chemotherapy recommended by guidelines.
Arm group label:
QL1706 + standard chemotherapy
Arm group label:
QLS31905 + standard chemotherapy
Arm group label:
QLS31905 + standard chemotherapy + QL1706
Summary:
This study aims to evaluate the efficacy and safety of QLS31905 and/or QL1706 plus
chemotherapy in patients with Claudin18.2-positive advanced solid tumors.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Subjects voluntarily participate in the study and sign the informed consent form;
- 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:
- History of malignancies other than the target cancer within 5 years prior to the
first dose of the investigational product ;
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Contact:
Last name:
Lin Shen, M.D
Phone:
010-881965671
Email:
linshenpku@163.com
Start date:
June 30, 2024
Completion date:
December 1, 2027
Lead sponsor:
Agency:
Qilu Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Qilu Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06446388
