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

Qilu Pharmaceutical

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Advanced Malignant Neoplasm

Treatments: Drug: Irinotecan; Drug: Docetaxel; Drug: QLF31907

Study type: Interventional

Funder types: Industry

Identifiers

NCT06394713

QLF31907-202

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

QLF31907 in combination with Irinotecan

Experimental group

Treatment:

Drug: Irinotecan

Drug: QLF31907

QLF31907 in combination with Docetaxel

Experimental group

Treatment:

Drug: Docetaxel

Drug: QLF31907