Clinical trial NCT05649761: A Phase I Study of QL1604 in Subjects With Advanced Solid Tumors
Official title: A Phase I, Open-label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of QL1604, a Humanized Anti-PD-1 Monoclonal Antibody, in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-12-14
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a first-in-human (FIH), dose-escalation, PK expansion, monotherapy efficacy expansion, and open-label phase I clinical study assessing the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary efficacy of QL1604 injection （a humanized anti-PD-1 monoclonal antibody）in patients with advanced solid tumors.


Eligibility criteria: Inclusion Criteria:

1. Volunteer to participate in this clinical study; completely understand and know this study as well as sign the informed consent form (ICF);
2. Age ≥ 18 years and ≤ 70 years when ICF is signed;
3. Pts with histologically or cytologically confirmed advanced solid tumors;
4. At least one target lesion as defined per RECIST Version (v) 1.1;
5. Subjects who have disease progression or intolerable reactions after the currently available standard anti-cancer treatment previously received or refused prior cancer therapy regimen(s) ;
6. Eastern Cooperative Oncology Group performance status of 0 or 1;
7. Life expectancy of greater than 12 weeks;
8. Adequate hematologic and organ function;
9. Female subjects who are not pregnant or breastfeeding
10. Male and female subjects able to have children must agree to use highly effective method of contraception throughout the study and for at least 120 days after last dose;

Exclusion Criteria:

1. Known hypersensitivity to any monoclonal antibody, QL1604 and/or any of its excipients;
2. Active autoimmune disease that has required systemic treatment, replacement therapy is acceptable;
3. Subjects with major cardiovascular and cerebrovascular diseases;
4. Any condition that required systemic treatment with either corticosteroids (\> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before the first dose of study drug;
5. Subjects who have received surgery, radiotherapy, chemotherapy, targeted therapy, other anti-tumor treatments, or participating in other clinical studies is less than 4 weeks before the first administration of investigational product;
6. Received a live vaccine;
7. Infection with human immunodeficiency virus (HIV);
8. Known psychiatric or substance abuse disorders that would interfere with the requirements of the study;
9. History or current evidence of any condition, therapy, or laboratory abnormality, that might confound the results of the trial, or interfere with the participant's participation for the full duration of the study, or investigators/sponsor consider the subjects are not suitable for this trial.

Primary outcomes:
measure: Dose-limiting toxicity (DLT)
timeFrame: Up to 21 days after the first dose
measure: maximum tolerated dose(MTD)
timeFrame: Up to 21 days after the first dose
measure: recommended phase II dose (RP2D)
timeFrame: up to 2 years
Secondary outcomes:
measure: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Related AEs
timeFrame: up to 2 years
measure: Maximum Concentration (Cmax) of QL1604 in Solid Tumor Participants
timeFrame: up to 2 years
measure: Time to Maximum Concentration (Tmax) of QL1604 in Solid Tumor Participants
timeFrame: up to 2 years
measure: Terminal Half-Life (t ½) of QL1604 in Solid Tumor Participants
timeFrame: up to 2 years
measure: Area Under the Concentration-Time Curve of QL1604 From Time 0 to Day 28 (AUC 0-22) in Solid Tumor Participants
timeFrame: up to 22 days
measure: Objective Response Rate (ORR) According to RECIST 1.1
timeFrame: up to 2 years
measure: Disease Control Rate (DCR) According to RECIST 1.1
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Cancer Hospital of The University of Chinese Academy of Sciences
state: Zhejiang
Study officials:
References: