A Phase I Study of QL1604 in Subjects With Advanced Solid Tumors

Phase 1

Active, not recruiting

• Conditions: Advanced Solid Tumors
• Interventions: Drug: QL1604 injection

• Registration Number: NCT05649761
• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-29
• Primary Completion: 2020-07-10
• Status Verified: 2022-11
• Study First Submitted: 2022-11-24
• Study First Submitted QC: 2022-12-05
• Last Update Submitted: 2022-12-05
• Study First Posted: 2022-12-14
• Last Update Posted: 2022-12-14
• Study Completion: 2023-01-23

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 61

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
QL1604 injection	QL1604 injection	Participants will receive QL1604 injection 0.3 mg/kg,1mg/kg, 3mg/kg,10mg/kg, or 200mg intravenous every 2 weeks or every 3 weeks and will be continued until disease progression or unacceptable toxicity.

Primary Outcome Measures

Name	Time	Method
Dose-limiting toxicity (DLT)	Up to 21 days after the first dose	Dose-limiting toxicity (DLT)
maximum tolerated dose(MTD)	Up to 21 days after the first dose	maximum tolerated dose(MTD)
recommended phase II dose (RP2D)	up to 2 years	recommended phase II dose (RP2D)

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Related AEs	up to 2 years	according to NCI CTCAE V5.0
Maximum Concentration (Cmax) of QL1604 in Solid Tumor Participants	up to 2 years	Maximum Concentration (Cmax)
Time to Maximum Concentration (Tmax) of QL1604 in Solid Tumor Participants	up to 2 years	Time to Maximum Concentration (Tmax)
Terminal Half-Life (t ½) of QL1604 in Solid Tumor Participants	up to 2 years	Terminal Half-Life (t ½)
Area Under the Concentration-Time Curve of QL1604 From Time 0 to Day 28 (AUC 0-22) in Solid Tumor Participants	up to 22 days	Area Under the Concentration-Time Curve
Objective Response Rate (ORR) According to RECIST 1.1	up to 2 years	Objective Response Rate (ORR) According to RECIST 1.1
Disease Control Rate (DCR) According to RECIST 1.1	up to 2 years	Disease Control Rate (DCR) According to RECIST 1.1

Trial Locations

Locations (1)

Cancer Hospital of The University of Chinese Academy of Sciences; 🇨🇳 Hangzhou, Zhejiang, China