Clinical trial NCT06041035: A Study of QLS31905 Combination Chemotherapy as First-Line Treatment in Patients With Advanced Solid Tumors
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Solid Tumor
Keywords: CLDN18.2
QLS31905
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-09-18
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the efficacy and safety of QLS31905 plus chemotherapy in patients with Claudin18.2-positive advanced solid tumors.


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.

Primary outcomes:
measure: Maximum Tolerated Dose (MTD) (Part A)
timeFrame: Approximately 12 months
measure: Phase 2 Recommended Dose（RP2D)(Part A)
timeFrame: Approximately 12 months
measure: Objective response rate (ORR)(Part B)
timeFrame: Approximately 12 months
Secondary outcomes:
measure: Safety assessed by Adverse Events (AEs)
timeFrame: Approximately 12 months
measure: Safety assessed by incidence of serious adverse events (SAE)
timeFrame: Approximately 12 months
measure: Number of participants with laboratory value abnormalities and/or adverse events (AEs)
timeFrame: Approximately 12 months
measure: Progression Free Survival(PFS)
timeFrame: Approximately 12 months
measure: Duration Of Response (DOR)
timeFrame: Approximately 12 months
measure: Overall Survival (OS)
timeFrame: Approximately 12 months
measure: Pharmacokinetics(PK) of QLS31905: Maximum concentration (Cmax)
timeFrame: Approximately 12 months
measure: PK of QLS31905: Time of the maximum concentration (Tmax)
timeFrame: Approximately 12 months
measure: PK of QLS31905: Terminal elimination half-life (T1/2)
timeFrame: Approximately 12 months
measure: PK of QLS31905: Clearance (CL)
timeFrame: Approximately 12 months
measure: PK of QLS31905: Apparent volume of distribution during the terminal phase (Vz)
timeFrame: Approximately 12 months
measure: Number of anti-drug antibody (ADA) Positive Participants
timeFrame: Approximately 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
References: