RecruitingPhase 1Phase 2NCT06911827

A Study of QLP2117 in Combination With QL2107 in Advanced Solid Tumor Patients

A Phase Ib/II Open-Label, Dose-Escalation and Dose-expansion Clinical Study to Evaluate the Safety, Pharmacokinetics, Immunogenicity and Efficacy of QLP2117 in Combination With QL2107 in Advanced Solid Tumor Patients

Sponsor

Qilu Pharmaceutical Co., Ltd.

Enrollment

149 participants

Start Date

May 9, 2025

Study Type

INTERVENTIONAL

Conditions

Advanced Solid Tumor

Summary

The goal of this clinical trial is to evaluate the safety and efficacy of QLP2117 in combination with QL2107 in Advanced Solid Tumor Patients.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

Histological or cytological confirmation of recurrent or refractory advanced solid tumours, and have progressed on standard therapy, or are intolerable for available standard therapy, or there is no available standard therapy.
At least one measurable disease for expansion cohorts per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1(phase Iba dose escalation only requires at least one assessable lesion)
Eastern Cooperative Oncology Group Performance Status of 0 or 1
Agree to provide archived tumor tissue samples of primary or metastatic lesions.
Have adequate organ function as described in the protocol.

Exclusion Criteria7

Women who are pregnant or breastfeeding
HBsAg/HBcAb positive and HBV-DNA>1000 copy/mL;HCV-Ab positive and detection of HCV-RNA suggested viral replication
Is currently participating and receiving study medication in another study within 4 week prior to the first dose of study treatment
Has an active autoimmune disease that has required systemic treatment in past 2 years.
Has an active infection requiring systemic therapy
Has received a live vaccine wihtin 30 days of planned start of study treatment
Known history of, or any evidence of interstitial lung disease