A Study of QLS31905 Combination Chemotherapy as First-Line Treatment in Patients With Advanced Solid Tumors

Solid Tumor Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06041035
• Other study ID #: QLS31905-201
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: October 2023
• Est. completion date: October 2025

Study information

• Verified date: September 2023
• Source: Qilu Pharmaceutical Co., Ltd.
• Contact: Lin Shen, M.D
• Phone: 010-881965671
• Email: linshenpku[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 115
• Est. completion date: October 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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 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.

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

Drug:
• QLS31905
Administered as an intravenous infusion.
• Nab paclitaxel
125 mg/m2 administered as IV infusion on D1/D8/D15 of each cycle.
• Gemcitabine
1000 mg/m2 administered as IV infusion on D1/D8/D15 of each cycle.
• Oxaliplatin
85 mg/m2, intravenous infusion, D1/D15, up to 6 cycles.
• Capecitabine
1000 mg/m2, oral, bid, D1-D7,D15-D21, up to 6 cycles.
• Cisplatin
25 mg/m2, intravenous infusion, D1/D15, up to 6 cycles.

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	Maximum Tolerated Dose (MTD) (Part A)	As measured by number of participants experiencing dose related toxicity (DLT) in each escalating cohort.	Approximately 12 months
Primary	Phase 2 Recommended Dose(RP2D)(Part A)	Monitor for MTD, and minimal efficacious dose by monitoring responses at different dose levels.	Approximately 12 months
Primary	Objective response rate (ORR)(Part B)	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.	Approximately 12 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 12 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 12 months
Secondary	Number of participants with laboratory value abnormalities and/or adverse events (AEs)	Number of participants with potentially clinically significant laboratory values.	Approximately 12 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 progressive disease per RECIST 1.1 by investigator evaluation or death due to any cause (whichever occurs first).	Approximately 12 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 progressive disease as assessed by investigator evaluation per RECIST 1.1 or death due to any cause (whichever occurs first).	Approximately 12 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 12 months
Secondary	Pharmacokinetics(PK) of QLS31905: Maximum concentration (Cmax)	Cmax will be derived from the PK serum samples collected.	Approximately 12 months
Secondary	PK of QLS31905: Time of the maximum concentration (Tmax)	Tmax will be derived from the PK serum samples collected.	Approximately 12 months
Secondary	PK of QLS31905: Terminal elimination half-life (T1/2)	T1/2 will be derived from the PK serum samples collected.	Approximately 12 months
Secondary	PK of QLS31905: Clearance (CL)	CL will be derived from the PK serum samples collected.	Approximately 12 months
Secondary	PK of QLS31905: Apparent volume of distribution during the terminal phase (Vz)	Vz will be derived from the PK serum samples collected.	Approximately 12 months
Secondary	Number of anti-drug antibody (ADA) Positive Participants	Immunogenicity will be measured by the number of participants that are ADA positive.	Approximately 12 months