A Study of QLS31905 Combination Chemotherapy as First-Line Treatment in Patients With Advanced Solid Tumors
- Conditions
- Solid Tumor
- Interventions
- Registration Number
- NCT06041035
- Lead Sponsor
- Qilu Pharmaceutical Co., Ltd.
- Brief Summary
This study aims to evaluate the efficacy and safety of QLS31905 plus chemotherapy in patients with Claudin18.2-positive advanced solid tumors.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 115
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description QLS31905 + nab-paclitaxel + gemcitabine (Part A/B) Nab paclitaxel Pancreatic cancer participants will be treated with QLS31905 in combination with nab-paclitaxel and gemcitabine for part A of the study to establish the recommended dose of QLS31905 for part B. In part B, the participants will be treated with QLS31905 at a dose determined by the part A of the study in combination with nab-paclitaxel and gemcitabine. QLS31905 + nab-paclitaxel + gemcitabine (Part A/B) Gemcitabine Pancreatic cancer participants will be treated with QLS31905 in combination with nab-paclitaxel and gemcitabine for part A of the study to establish the recommended dose of QLS31905 for part B. In part B, the participants will be treated with QLS31905 at a dose determined by the part A of the study in combination with nab-paclitaxel and gemcitabine. QLS31905 + oxaliplatin + capecitabine (Part B) Oxaliplatin In part B, gastric/gastroesophageal junction cancer participants will be treated with QLS31905 at dose determined by part A of the study in combination with oxaliplatin and capecitabine. QLS31905 + nab-paclitaxel + gemcitabine (Part A/B) QLS31905 Pancreatic cancer participants will be treated with QLS31905 in combination with nab-paclitaxel and gemcitabine for part A of the study to establish the recommended dose of QLS31905 for part B. In part B, the participants will be treated with QLS31905 at a dose determined by the part A of the study in combination with nab-paclitaxel and gemcitabine. QLS31905 + oxaliplatin + capecitabine (Part B) QLS31905 In part B, gastric/gastroesophageal junction cancer participants will be treated with QLS31905 at dose determined by part A of the study in combination with oxaliplatin and capecitabine. QLS31905 + gemcitabine+cisplatin(Part B) QLS31905 In part B, other solid tumor participants including but not limited to biliary tract cancer will be treated with QLS31905 at dose determined by part A in combination with standard chemotherapy recommended by guidelines.QLS31905 plus gemcitabine+ cisplatin as the first-line treatment of advanced biliary tract cancer. QLS31905 + oxaliplatin + capecitabine (Part B) Capecitabine In part B, gastric/gastroesophageal junction cancer participants will be treated with QLS31905 at dose determined by part A of the study in combination with oxaliplatin and capecitabine. QLS31905 + gemcitabine+cisplatin(Part B) Gemcitabine In part B, other solid tumor participants including but not limited to biliary tract cancer will be treated with QLS31905 at dose determined by part A in combination with standard chemotherapy recommended by guidelines.QLS31905 plus gemcitabine+ cisplatin as the first-line treatment of advanced biliary tract cancer. QLS31905 + gemcitabine+cisplatin(Part B) Cisplatin In part B, other solid tumor participants including but not limited to biliary tract cancer will be treated with QLS31905 at dose determined by part A in combination with standard chemotherapy recommended by guidelines.QLS31905 plus gemcitabine+ cisplatin as the first-line treatment of advanced biliary tract cancer.
- Primary Outcome Measures
Name Time Method Phase 2 Recommended Dose（RP2D)(Part A) Approximately 12 months Monitor for MTD, and minimal efficacious dose by monitoring responses at different dose levels.
Maximum Tolerated Dose (MTD) (Part A) Approximately 12 months As measured by number of participants experiencing dose related toxicity (DLT) in each escalating cohort.
Objective response rate (ORR)(Part B) Approximately 12 months ORR is defined as the proportion of participants who have a best overall response of Complete Response (CR) or Partial Response (PR) as assessed by investigator evaluation per RECIST 1.1.
- Secondary Outcome Measures
Name Time Method Safety assessed by incidence of serious adverse events (SAE) Approximately 12 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.
PK of QLS31905: Time of the maximum concentration (Tmax) Approximately 12 months Tmax will be derived from the PK serum samples collected.
PK of QLS31905: Terminal elimination half-life (T1/2) Approximately 12 months T1/2 will be derived from the PK serum samples collected.
Progression Free Survival(PFS) Approximately 12 months PFS is defined as the duration from the subject's first dose of the investigational product to the first imaging confirmation of progressive disease per RECIST 1.1 by investigator evaluation or death due to any cause (whichever occurs first).
Safety assessed by Adverse Events (AEs) Approximately 12 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.
Overall Survival (OS) Approximately 12 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.
Number of participants with laboratory value abnormalities and/or adverse events (AEs) Approximately 12 months Number of participants with potentially clinically significant laboratory values.
Duration Of Response (DOR) Approximately 12 months DOR is defined as the time from the date of the first response (CR/PR) until the date of progressive disease as assessed by investigator evaluation per RECIST 1.1 or death due to any cause (whichever occurs first).
Pharmacokinetics(PK) of QLS31905: Maximum concentration (Cmax) Approximately 12 months Cmax will be derived from the PK serum samples collected.
Number of anti-drug antibody (ADA) Positive Participants Approximately 12 months Immunogenicity will be measured by the number of participants that are ADA positive.
PK of QLS31905: Clearance (CL) Approximately 12 months CL will be derived from the PK serum samples collected.
PK of QLS31905: Apparent volume of distribution during the terminal phase (Vz) Approximately 12 months Vz will be derived from the PK serum samples collected.
Trial Locations
- Locations (1)
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China