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

Status

Not yet recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06394713

Enrollment

Registered

2024-05-01

Start date

2024-06-15

Completion date

2026-12-15

Last updated

2024-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Malignant Neoplasm

Brief summary

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

Interventions

DRUGQLF31907

intravenous administration, once every 3 weeks

DRUGIrinotecan

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

DRUGDocetaxel

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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;

Design outcomes

Primary

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

Secondary

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

Contacts

Primary ContactLin Shen

doctorshenlin@sina.cn010-88196561

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026