Actively Recruiting
A Phase I Study of QLP2117 in Subjects With Advanced Solid Tumors
Led by Qilu Pharmaceutical Co., Ltd. · Updated on 2024-06-27
180
Participants Needed
1
Research Sites
136 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase I Study of QLP2117 in Subjects With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histological or cytological confirmation of recurrent or refractory advanced solid tumors that have progressed on standard therapy, are intolerable for available standard therapy, or have no available standard therapy
- At least one measurable disease for expansion cohorts per RECIST v1.1 (phase Ia dose escalation requires at least one assessable lesion)
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Agreement to provide archived tumor tissue samples of primary or metastatic lesions
- Adequate organ function as described in the protocol
You will not qualify if you...
- Women who are pregnant or breastfeeding
- Positive for HBsAg/HBcAb with HBV-DNA >1000 copy/mL; positive for HCV-Ab with detection of HCV-RNA indicating viral replication
- Currently participating and receiving study medication in another study within 4 weeks prior to first dose of study treatment
- Active autoimmune disease requiring systemic treatment in past 2 years
- Active infection requiring systemic therapy
- Received a live vaccine within 30 days before planned start of study treatment
- Known history of, or any evidence of interstitial lung disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, China
Actively Recruiting
Research Team
Z
Zhang Meijiang, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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