Study of QLS31905 and/or QL1706 Combination With Chemotherapy in the Advanced Malignant Solid Tumors
- 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.
- Short title
- Study of QLS31905 and/or QL1706 Combination With Chemotherapy in the Advanced Malignant Solid Tumors
- Official title
- A Phase II Clinical Study to Evaluate the Efficacy and Safety of QLS31905 and/or QL1706 Combination Chemotherapy for the Treatment of CLDN18.2-Positive Advanced Malignant Solid Tumors
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Not yet recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2027-12-01
- First posted
- 2024-06-06
- Registry last updated
- 2024-06-06
- Primary completion date
- 2026-06-30
- Start date
- 2024-06-30
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Registry sponsor category
- Industry
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06446388
- ClinicalTrials.gov ID
- NCT06446388
- Registry record
- Open registry record
- Allocation
- Not randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- No masking
Objective response rate (ORR)
Timeframe: Approximately 24 months
ORR is defined as the proportion of participants who have a best overall response of Complete Response (CR) or Partial Response (PR)
Safety assessed by Adverse Events (AEs)
Timeframe: Approximately 24 months
An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom,or disease (new or exacerbated) temporally associated with the use of a medicinal product.
Safety assessed by incidence of serious adverse events (SAE)
Timeframe: Approximately 24 months
Adverse Event (AE) is considered "serious" if the investigator or sponsor view any of the following outcomes: Death, life-threatening, persistent or significant disability/incapacity, congenital anomaly or birth defect,hospitalization, or medically important event.
Number of participants with laboratory value abnormalities
Timeframe: Approximately 24 months
Number of participants with potentially clinically significant laboratory values.
Duration of Response (DOR)
Timeframe: Approximately 24 months
DOR is defined as the time from the date of the first response (CR/PR) until the date of radiological progressive disease or death due to any cause (whichever occurs first).
Progression Free Survival(PFS)
Timeframe: Approximately 24 months
PFS is defined as the duration from the subject's first dose of the investigational product to the first imaging confirmation of radiological progressive disease or death due to any cause (whichever occurs first).
Overall Survival (OS)
Timeframe: Approximately 24 months
OS is defined as the duration from the first dose of the investigational product to the time point when death occurs due to any cause.
Maximum concentration (Cmax)
Timeframe: Approximately 24 months
Cmax will be derived from the PK serum samples collected.
Time of the maximum concentration (Tmax)
Timeframe: Approximately 24 months
Tmax will be derived from the PK serum samples collected.
Terminal elimination half-life (T1/2)
Timeframe: Approximately 24 months
T1/2 will be derived from the PK serum samples collected.
Clearance (CL)
Timeframe: Approximately 24 months
CL will be derived from the PK serum samples collected.
Apparent volume of distribution during the terminal phase (Vz)
Timeframe: Approximately 24 months
Vz will be derived from the PK serum samples collected.
Number of anti-drug antibody (ADA) Positive Participants
Timeframe: Approximately 24 months
Immunogenicity will be measured by the number of participants that are ADA positive.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Healthy volunteers
- No
- 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.
- 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.
- Beijing Cancer HospitalBeijing, China