A Phase I Study of QLP2117 in Subjects With Advanced Solid Tumors
A Study Evaluates the Safety, Pharmacokinetics, Immunogenicity and Efficacy of QLP2117 in Advanced Solid Tumor Patients
1 other identifier
interventional
180
1 country
1
Brief Summary
This is the first in human study of QLP2117. To evaluate the Safety, Pharmacokinetics, Immunogenicity and Efficacy of QLP2117 in patients with advanced solid tumors.
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 2023
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
April 4, 2023
CompletedFirst Posted
Study publicly available on registry
April 26, 2023
CompletedStudy Start
First participant enrolled
May 19, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedJune 27, 2024
June 1, 2024
2 years
April 4, 2023
June 25, 2024
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 1b
up to 96 weeks
Study Arms (2)
Ia： QLP2117 Dose escalation and PK expansion
EXPERIMENTALIb：QLP2117 Dose expansion
EXPERIMENTALInterventions
Specified dose on specified days
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 Ia 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
- Has know 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, China
Study Officials
- PRINCIPAL INVESTIGATOR
Xu Ruihua, PhD
Sun Yat-sen University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2023
First Posted
April 26, 2023
Study Start
May 19, 2023
Primary Completion
April 30, 2025
Study Completion
December 31, 2025
Last Updated
June 27, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share