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

• ClinicalTrials.gov Identifier: NCT05649761
• Recruitment Status: Active, not recruiting
• First Posted: December 14, 2022
• Last Update Posted: December 14, 2022
• Sponsor: Qilu Pharmaceutical Co., Ltd.
• Information provided by (Responsible Party): Qilu Pharmaceutical Co., Ltd.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Advanced Solid Tumors	Drug: QL1604 injection	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 61 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: May 29, 2019
• Actual Primary Completion Date: July 10, 2020
• Estimated Study Completion Date: January 23, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Dose-limiting toxicity (DLT) [ Time Frame: Up to 21 days after the first dose ]
   Dose-limiting toxicity (DLT)
2. maximum tolerated dose(MTD) [ Time Frame: Up to 21 days after the first dose ]
   maximum tolerated dose(MTD)
3. recommended phase II dose (RP2D) [ Time Frame: up to 2 years ]
   recommended phase II dose (RP2D)

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

China, Zhejiang

Cancer Hospital of The University of Chinese Academy of Sciences

Hangzhou, Zhejiang, China, 310022

Sponsors and Collaborators

Qilu Pharmaceutical Co., Ltd.

More Information

• Responsible Party: Qilu Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT05649761
• Other Study ID Numbers: QL1604-001
• First Posted: December 14, 2022
• Last Update Posted: December 14, 2022
• Last Verified: November 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Neoplasms