Clinical trial
A Phase IB/II Clinical Study to Assess the Efficacy and Safety of QLS31905 in Combination With Chemotherapy as First-line Treatment in Patients With Claudin 18.2 (CLDN18.2) Positive Advanced Malignant Solid Tumors
Name
QLS31905-201
Description
This study aims to evaluate the efficacy and safety of QLS31905 plus chemotherapy in patients with Claudin18.2-positive advanced solid tumors.
Trial arms
Trial start
2023-10-01
Estimated PCD
2024-10-01
Trial end
2025-10-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
QLS31905
Administered as an intravenous infusion.
Arms:
QLS31905 + gemcitabine+cisplatin(Part B), QLS31905 + nab-paclitaxel + gemcitabine (Part A/B), QLS31905 + oxaliplatin + capecitabine (Part B)
Nab paclitaxel
125 mg/m2 administered as IV infusion on D1/D8/D15 of each cycle.
Arms:
QLS31905 + nab-paclitaxel + gemcitabine (Part A/B)
Gemcitabine
1000 mg/m2 administered as IV infusion on D1/D8/D15 of each cycle.
Arms:
QLS31905 + gemcitabine+cisplatin(Part B), QLS31905 + nab-paclitaxel + gemcitabine (Part A/B)
Oxaliplatin
85 mg/m2, intravenous infusion, D1/D15, up to 6 cycles.
Arms:
QLS31905 + oxaliplatin + capecitabine (Part B)
Capecitabine
1000 mg/m2, oral, bid, D1-D7,D15-D21, up to 6 cycles.
Arms:
QLS31905 + oxaliplatin + capecitabine (Part B)
Cisplatin
25 mg/m2, intravenous infusion, D1/D15, up to 6 cycles.
Arms:
QLS31905 + gemcitabine+cisplatin(Part B)
Size
115
Primary endpoint
Maximum Tolerated Dose (MTD) (Part A)
Approximately 12 months
Phase 2 Recommended Dose（RP2D)(Part A)
Approximately 12 months
Objective response rate (ORR)(Part B)
Approximately 12 months
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 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:
* 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 115, 'type': 'ESTIMATED'}}
Updated at
2023-09-18
1 organization
6 products
1 indication
Organization
Qilu PharmaceuticalProduct
Nab paclitaxelIndication
Solid TumorProduct
OxaliplatinProduct
CisplatinProduct
QLS31905Product
GemcitabineProduct
Capecitabine