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

NCT05649761 | Unknown Phase 1

• 1 other identifier: QL1604-001
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Related AEs

  up to 2 years

• Maximum Concentration (Cmax) of QL1604 in Solid Tumor Participants

  up to 2 years

• Time to Maximum Concentration (Tmax) of QL1604 in Solid Tumor Participants

  up to 2 years

• Terminal Half-Life (t ½) of QL1604 in Solid Tumor Participants

  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

  up to 22 days

Study Arms (1)

QL1604 injection

EXPERIMENTAL

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

Interventions

QL1604 injection DRUG

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.

QL1604 injection

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteer to participate in this clinical study; completely understand and know this study as well as sign the informed consent form (ICF);
• Age ≥ 18 years and ≤ 70 years when ICF is signed;
• Pts with histologically or cytologically confirmed advanced solid tumors;
• At least one target lesion as defined per RECIST Version (v) 1.1;
• 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) ;
• Eastern Cooperative Oncology Group performance status of 0 or 1;
• Life expectancy of greater than 12 weeks;
• Adequate hematologic and organ function;
• Female subjects who are not pregnant or breastfeeding
• 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;

You may not qualify if:

• Known hypersensitivity to any monoclonal antibody, QL1604 and/or any of its excipients;
• Active autoimmune disease that has required systemic treatment, replacement therapy is acceptable;
• Subjects with major cardiovascular and cerebrovascular diseases;
• 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;
• 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;
• Received a live vaccine;
• Infection with human immunodeficiency virus (HIV);
• Known psychiatric or substance abuse disorders that would interfere with the requirements of the study;
• 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.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Cancer Hospital of The University of Chinese Academy of Sciences

Hangzhou, Zhejiang, 310022, China

Location

Related Publications (1)

• Huang Z, Xu Y, Hong W, Gong L, Chen K, Qin J, Xie F, Wang F, Tian X, Meng X, Feng W, Li L, Zhang B, Kang X, Fan Y. A first-in-human, open-label, dose-escalation and dose-expansion phase I study to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics, and antitumor activity of QL1604, a humanized anti-PD-1 mAb, in patients with advanced or metastatic solid tumors. Front Immunol. 2023 Oct 23;14:1258573. doi: 10.3389/fimmu.2023.1258573. eCollection 2023.

  PMID: 37936687 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2022
• First Posted: December 14, 2022
• Study Start: May 29, 2019
• Primary Completion: July 10, 2020
• Study Completion: January 23, 2023
• Last Updated: December 14, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)