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

Advanced Malignant Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06394713
• Other study ID #: QLF31907-202
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: June 15, 2024
• Est. completion date: December 15, 2026

Study information

• Verified date: April 2024
• Source: Qilu Pharmaceutical Co., Ltd.
• Contact: Lin Shen
• Phone: 010-88196561
• Email: doctorshenlin[@]sina.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 15, 2026
• Est. primary completion date: June 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Advanced Malignant Neoplasm
• Neoplasms

Intervention

Drug:
• QLF31907
intravenous administration, once every 3 weeks
• Irinotecan
intravenous administration, 125 mg/m2, d1 and d8, every 3 weeks
• Docetaxel
intravenous administration, 75mg/m2, d1, every 3 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Pharmaceutical Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	phase Ib: Dose-limiting toxicity(DLT)	The DLT of QLF31907 combination therapy will be determined	28 days
Primary	phase2: objective response rate(ORR)	the ORR of QLF31907 combinaton therapy will be determined	up to 2 years
Secondary	adverse events (AEs) of QLF31907 combination therapy	to evaluate the severity, incidence and causality of adverse events (AEs)	up to 2 years
Secondary	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
Secondary	Immunogenicity of QLF31907	the anti-drug antibody(ADA) against QLF31907 will be determined	up to 2 years
Secondary	overall survival(OS)	the OS of QLF31907 combination therapy will be determined	up to 2 years
Secondary	maximum plasma concentration (Cmax) of QLF31907	the maximum plasma concentration (Cmax) of QLF31907 will be determined	up to 2 years