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
1 other identifier
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2025
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 28, 2025
CompletedFirst Posted
Study publicly available on registry
April 4, 2025
CompletedStudy Start
First participant enrolled
May 9, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
February 25, 2026
February 1, 2026
2.6 years
March 28, 2025
February 24, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Dose-limiting toxicity(DLT)
21days
Percentage of Participants Experiencing Adverse Events (AEs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
up to 96 weeks
Objective Response Rate for phase II
up to 96 weeks
Study Arms (1)
Ib/II
EXPERIMENTAL* Experimental: Ib： QLP2117 in combination with QL2107 Dose escalation and PK expansion * Experimental: II： QLP2117 in combination with QL2107 Dose expansion
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2025
First Posted
April 4, 2025
Study Start
May 9, 2025
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2028
Last Updated
February 25, 2026
Record last verified: 2026-02