A Study of QLP2117 in Combination With QL2107 in Advanced Solid Tumor Patients
ConditionAdvanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorQilu Pharmaceutical Co., Ltd.
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
QLP2117
DrugSpecified dose on specified days
QL2107
DrugSpecified dose on specified days
Treatment groups
149 Participants
are divided into 1 treatment groupGroup A: Ib/IIExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Dose-limiting toxicity(DLT)
Time frame
21days2
Percentage of Participants Experiencing Adverse Events (AEs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Time frame
up to 96 weeks3
Objective Response Rate for phase II
Time frame
up to 96 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov