Study of QLS31905 and/or QL1706 Combination With Chemotherapy in the Advanced Malignant Solid Tumors
Phase 2
Not yet recruiting
- Conditions
- Interventions
- Registration Number
- NCT06446388
- Lead Sponsor
- Qilu Pharmaceutical Co., Ltd.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 360
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.
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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.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description QLS31905 + oxaliplatin + capecitabine QLS31905 Gastric/gastroesophageal junction cancer participants will be treated with QLS31905 at doses determined by the phase I study in combination with oxaliplatin and capecitabine. QLS31905 + oxaliplatin + capecitabine Oxaliplatin Gastric/gastroesophageal junction cancer participants will be treated with QLS31905 at doses determined by the phase I study in combination with oxaliplatin and capecitabine. QLS31905 + oxaliplatin + capecitabine Capecitabine Gastric/gastroesophageal junction cancer participants will be treated with QLS31905 at doses determined by the phase I study in combination with oxaliplatin and capecitabine. QL1706 + oxaliplatin + capecitabine Oxaliplatin Gastric/gastroesophageal junction cancer participants will be treated with QL1706 in combination with oxaliplatin and capecitabine. QL1706 + oxaliplatin + capecitabine Capecitabine Gastric/gastroesophageal junction cancer participants will be treated with QL1706 in combination with oxaliplatin and capecitabine. QL1706 + oxaliplatin + capecitabine QL1706 Gastric/gastroesophageal junction cancer participants will be treated with QL1706 in combination with oxaliplatin and capecitabine. QLS31905 + oxaliplatin + capecitabine + QL1706 QLS31905 Gastric/gastroesophageal junction cancer participants will be treated with QLS31905 at doses determined by the phase I study in combination with oxaliplatin and capecitabine+ QL1706. QLS31905 + oxaliplatin + capecitabine + QL1706 Oxaliplatin Gastric/gastroesophageal junction cancer participants will be treated with QLS31905 at doses determined by the phase I study in combination with oxaliplatin and capecitabine+ QL1706. QLS31905 + oxaliplatin + capecitabine + QL1706 Capecitabine Gastric/gastroesophageal junction cancer participants will be treated with QLS31905 at doses determined by the phase I study in combination with oxaliplatin and capecitabine+ QL1706. QLS31905 + gemcitabine+cisplatin QLS31905 Biliary tract cancer will be treated with QLS31905 at doses determined by the phase I study in combination with gemcitabine and cisplatin. QL1706 + gemcitabine+cisplatin Cisplatin Biliary tract cancer will be treated with QL1706 in combination with gemcitabine and cisplatin. QL1706 + gemcitabine+cisplatin QL1706 Biliary tract cancer will be treated with QL1706 in combination with gemcitabine and cisplatin. QLS31905 + gemcitabine+cisplatin+ QL1706 QLS31905 Biliary tract cancer will be treated with QLS31905 at doses determined by the phase I study in combination with gemcitabine and cisplatin+ QL1706. QLS31905 + gemcitabine+cisplatin+ QL1706 Cisplatin Biliary tract cancer will be treated with QLS31905 at doses determined by the phase I study in combination with gemcitabine and cisplatin+ QL1706. QLS31905 + standard chemotherapy QLS31905 Other solid tumor participants will be treated with QLS31905 at doses determined by the phase I study in combination with standard chemotherapy recommended by guidelines. QLS31905 + standard chemotherapy Chemotherapy drug Other solid tumor participants will be treated with QLS31905 at doses determined by the phase I study in combination with standard chemotherapy recommended by guidelines. QL1706 + standard chemotherapy QL1706 Other solid tumor participants will be treated with QL1706 in combination with standard chemotherapy recommended by guidelines. QL1706 + standard chemotherapy Chemotherapy drug Other solid tumor participants will be treated with QL1706 in combination with standard chemotherapy recommended by guidelines. QLS31905 + standard chemotherapy + QL1706 QLS31905 Other solid tumor participants will be treated with QLS31905 at doses determined by the phase I study in combination with standard chemotherapy and QL1706. QLS31905 + standard chemotherapy + QL1706 QL1706 Other solid tumor participants will be treated with QLS31905 at doses determined by the phase I study in combination with standard chemotherapy and QL1706. QLS31905 + standard chemotherapy + QL1706 Chemotherapy drug Other solid tumor participants will be treated with QLS31905 at doses determined by the phase I study in combination with standard chemotherapy and QL1706. QLS31905 + oxaliplatin + capecitabine + QL1706 QL1706 Gastric/gastroesophageal junction cancer participants will be treated with QLS31905 at doses determined by the phase I study in combination with oxaliplatin and capecitabine+ QL1706. QLS31905 + gemcitabine+cisplatin Cisplatin Biliary tract cancer will be treated with QLS31905 at doses determined by the phase I study in combination with gemcitabine and cisplatin. QLS31905 + gemcitabine+cisplatin Gemcitabine Biliary tract cancer will be treated with QLS31905 at doses determined by the phase I study in combination with gemcitabine and cisplatin. QL1706 + gemcitabine+cisplatin Gemcitabine Biliary tract cancer will be treated with QL1706 in combination with gemcitabine and cisplatin. QLS31905 + gemcitabine+cisplatin+ QL1706 Gemcitabine Biliary tract cancer will be treated with QLS31905 at doses determined by the phase I study in combination with gemcitabine and cisplatin+ QL1706. QLS31905 + gemcitabine+cisplatin+ QL1706 QL1706 Biliary tract cancer will be treated with QLS31905 at doses determined by the phase I study in combination with gemcitabine and cisplatin+ QL1706.
- Primary Outcome Measures
Name Time Method Objective response rate (ORR) 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)
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) 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.
Duration of Response (DOR) 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) 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).
Maximum concentration (Cmax) Approximately 24 months Cmax will be derived from the PK serum samples collected.
Safety assessed by incidence of serious adverse events (SAE) 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.
Safety assessed by Adverse Events (AEs) 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 med...
Number of participants with laboratory value abnormalities Approximately 24 months Number of participants with potentially clinically significant laboratory values.
Time of the maximum concentration (Tmax) Approximately 24 months Tmax will be derived from the PK serum samples collected.
Terminal elimination half-life (T1/2) Approximately 24 months T1/2 will be derived from the PK serum samples collected.
Clearance (CL) Approximately 24 months CL will be derived from the PK serum samples collected.
Apparent volume of distribution during the terminal phase (Vz) Approximately 24 months Vz will be derived from the PK serum samples collected.
Number of anti-drug antibody (ADA) Positive Participants Approximately 24 months Immunogenicity will be measured by the number of participants that are ADA positive.
Trial Locations
- Locations (1)
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China