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

November 1, 2022 updated by: Qilu Pharmaceutical Co., Ltd.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is an open, multicenter phase Ib/II trial of QL1706 or QL1604 combined with bevacizumabin patients with advanced hepatocellular carcinoma to evaluate the safety, PK characteristics and preliminary efficacy. This trial is divided into three cohorts, Cohort A, Cohort B and Cohort C.

Cohort A was the dose exploration phase of the study, with 2 dose groups designed, QL1706 5mg/kg q3w + bevacizumab 7.5mg/kg q3w group and QL1706 5mg/kg q3w + bevacizumab 15mg/kg q3w group, to explore the safe dose of bevacizumab.

After approximately 20 cases are enrolled in the bevacizumab safety dose group identified in Cohort A, enrollment will be initiated in Cohort B. Cohort B will be QL1604 200 mg fixed dose q3w + bevacizumab safety dose, and random enrollment will be used for both Cohort A and Cohort B.

The decision to initiate a cohort C study will be based on the preliminary results of the efficacy analysis of cohort A and cohort B. If a Cohort C study is initiated, the Cohort C dosing regimen will be QL1706 7.5 mg/kg q3w + bevacizumab safe dose q3w.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Hospital, Sichuan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subjects participated voluntarily and signed an informed consent form.
  2. Age ≥ 18 years old at the time of signing the informed consent form, male or female.
  3. 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.
  4. No prior systemic treatment for HCC.
  5. Child-Pugh liver function classification of grade A versus better grade B.
  6. Eastern Cooperative Oncology Group (ECOG) physical status score of 0-1.
  7. 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.

Exclusion Criteria:

  1. Subjects with symptomatic CNS metastases were not allowed to be enrolled.
  2. Patients with a history of other malignancies within 5 years prior to signing informed consent.
  3. Active autoimmune disease that may have worsened during the course of receiving study drug therapy.
  4. Concomitant disease that interferes with the subject's ability to complete the study.
  5. History of allogeneic hematopoietic stem cell transplantation or organ transplantation.
  6. HIV-positive patients; HCV antibody-positive and HCV RNA-positive patients; patients with co-infection with HBV and HCV.
  7. Patients with a known history of psychotropic substance abuse, alcoholism, or drug use
  8. 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
  9. Prior immunotherapy or prior targeted therapy.
  10. PCP treatment requires 2 weeks of elution before enrollment and is prohibited during the trial.
  11. Known previous hypersensitivity to macromolecular protein agents, or any component of the test drug.
  12. Live vaccination within 4 weeks prior to the first administration of the test drug.
  13. History of hemoptysis, or history of gastrointestinal bleeding, intestinal obstruction and/or previous clinical signs or symptoms of gastrointestinal obstruction.
  14. Abdominal or bronchoesophageal fistula, gastrointestinal perforation or intra-abdominal abscess, major vascular disease.
  15. Current or recent treatment with aspirin, clopidogrel, or current or recent treatment with dipyridamole, ticlopidine, and cilostazol; use of anticoagulation therapy for therapeutic purposes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: QL1706(5mg/kg)
QL1706(5mg/kg) Combined with Bevacizumab
Drug: QL1706
5 mg/kg#D1#Q3W IV or 7.5 mg/kg#D1#Q3W IV
Drug: Bevacizumab
15 mg/kg#D1#Q3W IV or 7.5 mg/kg#D1#Q3W IV
Experimental: QL1604
QL1604 Combined with Bevacizumab
Drug: Bevacizumab
15 mg/kg#D1#Q3W IV or 7.5 mg/kg#D1#Q3W IV
Drug: QL1604
200mg#D1#Q3W IV
Experimental: QL1706(7.5mg/kg)
QL1706(7.5mg/kg) Combined with Bevacizumab
Drug: QL1706
5 mg/kg#D1#Q3W IV or 7.5 mg/kg#D1#Q3W IV
Drug: Bevacizumab
15 mg/kg#D1#Q3W IV or 7.5 mg/kg#D1#Q3W IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective remission rate (ORR)
Time Frame: up to 1year
The ORR assessed according to RECIST v1.1
up to 1year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of remission (DOR) Duration of remission (DOR) Duration of remission (DOR) Duration of remission (DOR)
Time Frame: Every 6 weeks up to 48 weeks during study, and every 12 weeks after the end of treatment up to 1year.
The DOR assessed according to RECIST v1.1
Every 6 weeks up to 48 weeks during study, and every 12 weeks after the end of treatment up to 1year.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Control Rate (DCR) Disease Control Rate (DCR) Disease Control Rate (DCR)
Time Frame: Every 6 weeks up to 48 weeks during study, and every 12 weeks after the end of treatment up to 1year.
The DCR assessed according to RECIST v1.1
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)
Time Frame: Every 6 weeks up to 48 weeks during study, and every 12 weeks after the end of treatment up to 1year.
The PFS and progression-free survival at 6 and 12 months (PFS6/12)
Every 6 weeks up to 48 weeks during study, and every 12 weeks after the end of treatment up to 1year.
Overall survival (OS)
Time Frame: 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.
The Overall survival and 1-year OS rate Overall survival Overall survival
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Anticipated)

December 30, 2023

Study Completion (Anticipated)

December 30, 2023

Study Registration Dates

First Submitted

October 21, 2022

First Submitted That Met QC Criteria

November 1, 2022

First Posted (Actual)

November 2, 2022

Study Record Updates

Last Update Posted (Actual)

November 2, 2022

Last Update Submitted That Met QC Criteria

November 1, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QL1706-106

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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