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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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 Criteria:
* 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
Primary outcome measure(s)
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
Trial sites (1)
Facility
City
Region
Status
Sun Yat-sen University Cancer Center
Guangzhou
Guangdong
Recruiting
More Qilu Pharmaceutical Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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