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

Advanced Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05649761
• Other study ID #: QL1604-001
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: May 29, 2019
• Est. completion date: January 23, 2023

Study information

• Verified date: November 2022
• Source: Qilu Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 61
• Est. completion date: January 23, 2023
• Est. primary completion date: July 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Cancer Hospital of The University of Chinese Academy of Sciences	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-limiting toxicity (DLT)	Dose-limiting toxicity (DLT)	Up to 21 days after the first dose
Primary	maximum tolerated dose(MTD)	maximum tolerated dose(MTD)	Up to 21 days after the first dose
Primary	recommended phase II dose (RP2D)	recommended phase II dose (RP2D)	up to 2 years
Secondary	Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Related AEs	according to NCI CTCAE V5.0	up to 2 years
Secondary	Maximum Concentration (Cmax) of QL1604 in Solid Tumor Participants	Maximum Concentration (Cmax)	up to 2 years
Secondary	Time to Maximum Concentration (Tmax) of QL1604 in Solid Tumor Participants	Time to Maximum Concentration (Tmax)	up to 2 years
Secondary	Terminal Half-Life (t ½) of QL1604 in Solid Tumor Participants	Terminal Half-Life (t ½)	up to 2 years
Secondary	Area Under the Concentration-Time Curve of QL1604 From Time 0 to Day 28 (AUC 0-22) in Solid Tumor Participants	Area Under the Concentration-Time Curve	up to 22 days
Secondary	Objective Response Rate (ORR) According to RECIST 1.1	Objective Response Rate (ORR) According to RECIST 1.1	up to 2 years
Secondary	Disease Control Rate (DCR) According to RECIST 1.1	Disease Control Rate (DCR) According to RECIST 1.1	up to 2 years