Status:
NOT_YET_RECRUITING
A Study of QLP2117 in Combination With QL2107 in Advanced Solid Tumor Patients
Lead Sponsor:
Qilu Pharmaceutical Co., Ltd.
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06911827
Start Date
April 1 2025
End Date
December 1 2028
Last Update
April 9 2025
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