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

Sponsor
Qilu Pharmaceutical Co., Ltd.
Study ID
NCT06394713
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Advanced Malignant Neoplasm

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Jun 15, 2024
Status verified
Apr 2024
Primary completion
Jun 15, 2025
Completion
Dec 15, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: QLF31907 in combination with Irinotecan
  • Experimental: QLF31907 in combination with Docetaxel

Primary Outcome Measure

phase Ib: Dose-limiting toxicity(DLT) [ Time Frame: 28 days ]

Central Contacts

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