A Phase Ib/II Trial to Evaluate the Safety and Efficacy of QL1706 in Patients With Advanced Hepatocellular Carcinoma

NCT05603039 | Unknown Phase 1

• 1 other identifier: QL1706-106
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase Ib/II trial to evaluate the safety, pharmacokinetics and preliminary efficacy of QL1706 or QL1604 combined with bevacizumab in patients with advanced hepatocellular carcinoma.

Conditions

Advanced Liver Cancer

Outcome Measures

Primary Outcomes (1)

• Objective remission rate (ORR)

  The ORR assessed according to RECIST v1.1

  up to 1year

Secondary Outcomes (1)

• Duration of remission (DOR) Duration of remission (DOR) Duration of remission (DOR) Duration of remission (DOR)

  Every 6 weeks up to 48 weeks during study, and every 12 weeks after the end of treatment up to 1year.

Other Outcomes (3)

• Disease Control Rate (DCR) Disease Control Rate (DCR) Disease Control Rate (DCR)

  Every 6 weeks up to 48 weeks during study, and every 12 weeks after the end of treatment up to 1year.

• Progression free survival (PFS)

  Every 6 weeks up to 48 weeks during study, and every 12 weeks after the end of treatment up to 1year.

• Overall survival (OS)

  From date of randomization until the date of death from any cause, , 12 months after the last use of the trial drug, or study completion/closure, whichever came first.

Study Arms (3)

QL1706(5mg/kg)

EXPERIMENTAL

QL1706(5mg/kg) Combined with Bevacizumab

Drug: QL1706; Drug: Bevacizumab

QL1604

EXPERIMENTAL

QL1604 Combined with Bevacizumab

Drug: QL1604; Drug: Bevacizumab

QL1706(7.5mg/kg)

EXPERIMENTAL

QL1706(7.5mg/kg) Combined with Bevacizumab

Drug: QL1706; Drug: Bevacizumab

Interventions

QL1706 DRUG

5 mg/kg#D1#Q3W IV or 7.5 mg/kg#D1#Q3W IV

QL1706(5mg/kg); QL1706(7.5mg/kg)

QL1604 DRUG

200mg#D1#Q3W IV

QL1604

Bevacizumab DRUG

15 mg/kg#D1#Q3W IV or 7.5 mg/kg#D1#Q3W IV

QL1604; QL1706(5mg/kg); QL1706(7.5mg/kg)

Eligibility Criteria

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

You may qualify if:

• Subjects participated voluntarily and signed an informed consent form.
• Age ≥ 18 years old at the time of signing the informed consent form, male or female.
• Advanced hepatocellular carcinoma diagnosed by histopathology or clinical diagnosis, with disease unsuitable for radical surgery and/or local treatment, or disease progression after surgery and/or local treatment.
• No prior systemic treatment for HCC.
• Child-Pugh liver function classification of grade A versus better grade B.
• Eastern Cooperative Oncology Group (ECOG) physical status score of 0-1.
• Expected survival ≥ 3 months.
• (9) Functional level of vital organs must be compliant prior to first administration of trial drug.
• (10) Subject agrees to use effective contraception for contraception from the time of signing the informed consent until 180 days after the last use of the trial drug. Females of childbearing age cannot be in pregnancy or breastfeeding.

You may not qualify if:

• Subjects with symptomatic CNS metastases were not allowed to be enrolled.
• Patients with a history of other malignancies within 5 years prior to signing informed consent.
• Active autoimmune disease that may have worsened during the course of receiving study drug therapy.
• Concomitant disease that interferes with the subject's ability to complete the study.
• History of allogeneic hematopoietic stem cell transplantation or organ transplantation.
• HIV-positive patients; HCV antibody-positive and HCV RNA-positive patients; patients with co-infection with HBV and HCV.
• Patients with a known history of psychotropic substance abuse, alcoholism, or drug use
• Those who have participated in other clinical studies and have used other clinical trial drugs within 4 weeks prior to the use of the trial drug
• Prior immunotherapy or prior targeted therapy.
• PCP treatment requires 2 weeks of elution before enrollment and is prohibited during the trial.
• Known previous hypersensitivity to macromolecular protein agents, or any component of the test drug.
• Live vaccination within 4 weeks prior to the first administration of the test drug.
• History of hemoptysis, or history of gastrointestinal bleeding, intestinal obstruction and/or previous clinical signs or symptoms of gastrointestinal obstruction.
• Abdominal or bronchoesophageal fistula, gastrointestinal perforation or intra-abdominal abscess, major vascular disease.
• Current or recent treatment with aspirin, clopidogrel, or current or recent treatment with dipyridamole, ticlopidine, and cilostazol; use of anticoagulation therapy for therapeutic purposes

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Interventions

Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Feng Professor Bi

CONTACT

028-85423203; bifenggcp@163.com

Study Design

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

Study Record Dates

• First Submitted: October 21, 2022
• First Posted: November 2, 2022
• Study Start: July 1, 2021
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: November 2, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)