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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: QL1604 injection

• Study Type: Interventional
• Enrollment (Anticipated): 61
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Cancer Hospital of The University of Chinese Academy of Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Related AEs	according to NCI CTCAE V5.0	up to 2 years
Maximum Concentration (Cmax) of QL1604 in Solid Tumor Participants	Maximum Concentration (Cmax)	up to 2 years
Time to Maximum Concentration (Tmax) of QL1604 in Solid Tumor Participants	Time to Maximum Concentration (Tmax)	up to 2 years
Terminal Half-Life (t ½) of QL1604 in Solid Tumor Participants	Terminal Half-Life (t ½)	up to 2 years
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
Objective Response Rate (ORR) According to RECIST 1.1	Objective Response Rate (ORR) According to RECIST 1.1	up to 2 years
Disease Control Rate (DCR) According to RECIST 1.1	Disease Control Rate (DCR) According to RECIST 1.1	up to 2 years

Collaborators and Investigators

• Sponsor: Qilu Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2019
• Primary Completion (Actual): July 10, 2020
• Study Completion (Anticipated): January 23, 2023

Study Registration Dates

• First Submitted: November 24, 2022
• First Submitted That Met QC Criteria: December 5, 2022
• First Posted (Estimate): December 14, 2022

Study Record Updates

• Last Update Posted (Estimate): December 14, 2022
• Last Update Submitted That Met QC Criteria: December 5, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: QL1604-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No