A Study to Evaluate the Efficacy and Safety of QLF31907 Combination Therapy in Patients With Advanced Malignant Tumors

A Phase 1b/2 Trial to Evaluate the Efficacy and Safety of QLF31907 (PD-L1/4-1BB Bi-specific Antibody) Combination Therapy in Patients With Advanced Malignant Tumors

This study is designed to evaluate the safety and efficacy of QLF31907 combination therapy in advanced malignant tumors.

Study Overview

• Status: Not yet recruiting
• Conditions: Advanced Malignant Neoplasm
• Intervention / Treatment: Drug: QLF31907; Drug: Irinotecan; Drug: Docetaxel

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Lin Shen; Phone Number: 010-88196561; Email: doctorshenlin@sina.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. subjects voluntarily participated and signed a written informed consent form;
2. age ≥18 years, male or female;
3. ECOG PS 0-1;
4. histopathologically diagnosed advanced malignant tumors;
5. at least 1 measurable lesion according to RECIST v1.1 criteria or Lugano (2014) criteria;
6. adequate organ function;

Exclusion Criteria:

1. previous treatment with 4-1BB agonist or 4-1BB recombinant fusion protein;
2. received anti-tumor therapy within 4 weeks prior to the first study treatment;
3. history of autoimmune disease;
4. history of other active malignancies within 3 years prior to the first treatment;
5. history of serous cardiovascular events;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: QLF31907 in combination with Irinotecan	Drug: QLF31907; intravenous administration, once every 3 weeks; Drug: Irinotecan; intravenous administration, 125 mg/m2, d1 and d8, every 3 weeks
Experimental: QLF31907 in combination with Docetaxel	Drug: QLF31907; intravenous administration, once every 3 weeks; Drug: Docetaxel; intravenous administration, 75mg/m2, d1, every 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
phase Ib: Dose-limiting toxicity(DLT)	The DLT of QLF31907 combination therapy will be determined	28 days
phase2: objective response rate(ORR)	the ORR of QLF31907 combinaton therapy will be determined	up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
adverse events (AEs) of QLF31907 combination therapy	to evaluate the severity, incidence and causality of adverse events (AEs)	up to 2 years
area under the concentration-time curve (AUC) of QLF31907	the area under the concentration-time curve (AUC) of QLF31907 will be determined	up to 2 years
Immunogenicity of QLF31907	the anti-drug antibody(ADA) against QLF31907 will be determined	up to 2 years
overall survival(OS)	the OS of QLF31907 combination therapy will be determined	up to 2 years
maximum plasma concentration (Cmax) of QLF31907	the maximum plasma concentration (Cmax) of QLF31907 will be determined	up to 2 years

Collaborators and Investigators

• Sponsor: Qilu Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2024
• Primary Completion (Estimated): June 15, 2025
• Study Completion (Estimated): December 15, 2026

Study Registration Dates

• First Submitted: April 22, 2024
• First Submitted That Met QC Criteria: April 29, 2024
• First Posted (Actual): May 1, 2024

Study Record Updates

• Last Update Posted (Actual): May 1, 2024
• Last Update Submitted That Met QC Criteria: April 29, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Topoisomerase Inhibitors; Topoisomerase I Inhibitors; Docetaxel; Irinotecan
• Other Study ID Numbers: QLF31907-202

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No