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

NCT ID: NCT06394713

Last Updated: 2024-05-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-15
• Study Completion Date: 2026-12-15

Brief Summary

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

Conditions

Advanced Malignant Neoplasm

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

QLF31907 in combination with Irinotecan

Group Type: EXPERIMENTAL

QLF31907

Intervention Type: DRUG

intravenous administration, once every 3 weeks

Irinotecan

Intervention Type: DRUG

intravenous administration, 125 mg/m2, d1 and d8, every 3 weeks

QLF31907 in combination with Docetaxel

Group Type: EXPERIMENTAL

QLF31907

Intervention Type: DRUG

intravenous administration, once every 3 weeks

Docetaxel

Intervention Type: DRUG

intravenous administration, 75mg/m2, d1, every 3 weeks

Interventions

QLF31907

intravenous administration, once every 3 weeks

Intervention Type: DRUG

Irinotecan

intravenous administration, 125 mg/m2, d1 and d8, every 3 weeks

Intervention Type: DRUG

Docetaxel

intravenous administration, 75mg/m2, d1, every 3 weeks

Intervention Type: DRUG

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qilu Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Lin Shen

Role: CONTACT

doctorshenlin@sina.cn

010-88196561

Other Identifiers

QLF31907-202

Identifier Type: -

Identifier Source: org_study_id