Study of QLS31905 and/or QL1706 Combination With Chemotherapy in the Advanced Malignant Solid Tumors

Advanced Solid Tumor Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06446388
• Other study ID #: QLS31905-202
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 30, 2024
• Est. completion date: December 1, 2027

Study information

• Verified date: May 2024
• Source: Qilu Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 360
• Est. completion date: December 1, 2027
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

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.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Drug:
• QLS31905
Administered as an intravenous infusion.
• Oxaliplatin
130 mg/m2, intravenous infusion, D1, up to 8 cycles.
• Capecitabine
1000 mg/m2, oral, bid, D1-D14
• Gemcitabine
1000 mg/m2 administered as IV infusion on D1/D8 of each cycle.
• Cisplatin
25 mg/m2, intravenous infusion, D1/D8, up to 8 cycles.
• QL1706
5 mg/kg, intravenous infusion,D1
• Chemotherapy drug
Standard chemotherapy recommended by guidelines.

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (ORR)	ORR is defined as the proportion of participants who have a best overall response of Complete Response (CR) or Partial Response (PR)	Approximately 24 months
Secondary	Safety assessed by Adverse Events (AEs)	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.	Approximately 24 months
Secondary	Safety assessed by incidence of serious adverse events (SAE)	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.	Approximately 24 months
Secondary	Number of participants with laboratory value abnormalities	Number of participants with potentially clinically significant laboratory values.	Approximately 24 months
Secondary	Duration of Response (DOR)	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).	Approximately 24 months
Secondary	Progression Free Survival(PFS)	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).	Approximately 24 months
Secondary	Overall Survival (OS)	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.	Approximately 24 months
Secondary	Maximum concentration (Cmax)	Cmax will be derived from the PK serum samples collected.	Approximately 24 months
Secondary	Time of the maximum concentration (Tmax)	Tmax will be derived from the PK serum samples collected.	Approximately 24 months
Secondary	Terminal elimination half-life (T1/2)	T1/2 will be derived from the PK serum samples collected.	Approximately 24 months
Secondary	Clearance (CL)	CL will be derived from the PK serum samples collected.	Approximately 24 months
Secondary	Apparent volume of distribution during the terminal phase (Vz)	Vz will be derived from the PK serum samples collected.	Approximately 24 months
Secondary	Number of anti-drug antibody (ADA) Positive Participants	Immunogenicity will be measured by the number of participants that are ADA positive.	Approximately 24 months