Clinical Trials /

ZZ06 in Adult Patients With Advanced EGFR Positive Solid Tumor Malignancies

NCT04412616

Description:

This is a Phase 1, Multicenter, Open-label study to assess the safety, tolerability and preliminary efficacy of ZZ06 in participants with all Adult Patients with Advanced EGFR-positive Solid Tumor Malignancies who are not able to have current standard anti-tumor therapies. The purpose of this study is to determine the maximum tolerated dose (MTD) , to characterise the safety, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activity of ZZ06 as a single agent in adult participants with advanced solid tumors.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

URL:

https://clinicaltrials.gov/show/NCT04412616

Trial Eligibility

Document

Title

  • Brief Title: ZZ06 in Adult Patients With Advanced EGFR Positive Solid Tumor Malignancies
  • Official Title: A Phase 1, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Evidence of Antitumor Activity of ZZ06 in Adult Patients With Advanced EGFR Positive Solid Tumor Malignancies

Clinical Trial IDs

  • ORG STUDY ID: ZZ06-2020A
  • NCT ID: NCT04412616

Conditions

  • Advanced EGFR Positive Solid Tumor

Interventions

DrugSynonymsArms
ZZ06ZZ06 0.03 mg/kg dose group

Purpose

This is a Phase 1, Multicenter, Open-label study to assess the safety, tolerability and preliminary efficacy of ZZ06 in participants with all Adult Patients with Advanced EGFR-positive Solid Tumor Malignancies who are not able to have current standard anti-tumor therapies. The purpose of this study is to determine the maximum tolerated dose (MTD) , to characterise the safety, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activity of ZZ06 as a single agent in adult participants with advanced solid tumors.

Detailed Description

      The study will start with an accelerated-titration dose escalation scheme, enrolling 1
      patient per cohort for the first 2 cohorts with expansion to 3 patients in the event of Grade
      ≥ 2 treatment-emergent adverse event (TEAE) or dose limiting toxicity (DLT) possibly,
      probably, or definitely related to the study drug. After the first 2 cohorts, the study will
      then proceed to a 3+3 design, with enrollment of 3 patients per cohort and expansion to 6
      patients in the event of a DLT.

Trial Arms

NameTypeDescriptionInterventions
ZZ06 0.03 mg/kg dose groupExperimentalZZ06 0.03 mg/kg will be administered twice weekly.A cycle is defined as continuous treatment for 28 days, and the initial treatment course is 2 cycles. Patients can receive up to 6 additional cycles unless disease progression, unacceptable toxicity, or other protocol specified stopping criteria occur. After 6 cycles, additional cycles may be given upon request by the Investigator and approval by the Medical Monitor.
  • ZZ06
ZZ06 0.06 mg/kg dose groupExperimentalZZ06 0.06 mg/kg will be administered twice weekly.A cycle is defined as continuous treatment for 28 days, and the initial treatment course is 2 cycles. Patients can receive up to 6 additional cycles unless disease progression, unacceptable toxicity, or other protocol specified stopping criteria occur. After 6 cycles, additional cycles may be given upon request by the Investigator and approval by the Medical Monitor.
  • ZZ06
ZZ06 0.12 mg/kg dose groupExperimentalZZ06 0.12 mg/kg will be administered twice weekly.A cycle is defined as continuous treatment for 28 days, and the initial treatment course is 2 cycles. Patients can receive up to 6 additional cycles unless disease progression, unacceptable toxicity, or other protocol specified stopping criteria occur. After 6 cycles, additional cycles may be given upon request by the Investigator and approval by the Medical Monitor.
  • ZZ06
ZZ06 0.22 mg/kg dose groupExperimentalZZ06 0.22 mg/kg will be administered twice weekly.A cycle is defined as continuous treatment for 28 days, and the initial treatment course is 2 cycles. Patients can receive up to 6 additional cycles unless disease progression, unacceptable toxicity, or other protocol specified stopping criteria occur. After 6 cycles, additional cycles may be given upon request by the Investigator and approval by the Medical Monitor.
  • ZZ06
ZZ06 0.39 mg/kg dose groupExperimentalZZ06 0.39 mg/kg will be administered twice weekly.A cycle is defined as continuous treatment for 28 days, and the initial treatment course is 2 cycles. Patients can receive up to 6 additional cycles unless disease progression, unacceptable toxicity, or other protocol specified stopping criteria occur. After 6 cycles, additional cycles may be given upon request by the Investigator and approval by the Medical Monitor.
  • ZZ06
ZZ06 0.70 mg/kg dose groupExperimentalZZ06 0.70 mg/kg will be administered twice weekly.A cycle is defined as continuous treatment for 28 days, and the initial treatment course is 2 cycles. Patients can receive up to 6 additional cycles unless disease progression, unacceptable toxicity, or other protocol specified stopping criteria occur. After 6 cycles, additional cycles may be given upon request by the Investigator and approval by the Medical Monitor.
  • ZZ06
ZZ06 1.00 mg/kg dose groupExperimentalZZ06 1.00 mg/kg will be administered twice weekly.A cycle is defined as continuous treatment for 28 days, and the initial treatment course is 2 cycles. Patients can receive up to 6 additional cycles unless disease progression, unacceptable toxicity, or other protocol specified stopping criteria occur. After 6 cycles, additional cycles may be given upon request by the Investigator and approval by the Medical Monitor.
  • ZZ06

Eligibility Criteria

        Inclusion Criteria:

          -  Patients with histologically or cytologically confirmed advanced solid tumor that is
             positive for EGFR and has progressed despite standard therapy or for whom no standard
             therapy exists.

          -  Patients are required to have archival tumor tissue available for assessment of EGFR
             status via FDA-approved EGFR assay .

          -  Age ≥ 18 years.

          -  Patients must have at least 1 measurable lesion as defined by RECIST v1.1.

          -  Eastern Cooperative Oncology Group performance status of 0 or 1.

          -  Life expectancy ≥ 12 weeks.

          -  Baseline organ function and laboratory data meet the following criteria:

               1. Bone marrow： ANC ≥ 1500 cells/mm3； Platelet count ≥ 75 000 cells/mm3； Hemoglobin
                  ≥ 8.0 g/dL.

               2. Coagulation： Prothrombin time ≤ 1.5× ULN； Activated partial thromboplastin time ≤
                  1.5× ULN；

               3. Renal function： Serum creatinine ≤ 1.5× ULN ； estimated glomerular filtration
                  rate≥ 60 mL/min (Cockcroft-Gault formula).

               4. Hepatic function： Serum total bilirubin ≤ 1.5 mg/dL； AST and ALT ≤ 3.0× ULN (if
                  metastases are present, ≤ 5.0× ULN).

          -  Females will not be pregnant or lactating, and females of childbearing potential and
             males will agree to use contraception.Patients must provide written informed consent
             prior to any study procedures.

        Exclusion Criteria:

          -  History of another primary cancer ≤ 3 years, with the exception of completely resected
             nonmelanoma skin cancer or carcinoma in situ of uterine cervix.

          -  Active or symptomatic CNS metastases. Patients with treated CNS metastases that have
             been stable for ≥ 4 weeks and do not require treatment with steroids or
             anticonvulsants may be enrolled at the discretion of the Investigator.

          -  Tests positive for hepatitis C virus, hepatitis B virus, or human immunodeficiency
             virus infection.

          -  Active, clinically significant infections.

          -  Clinically significant cardiovascular disease, including any of the following:

               1. Congestive heart failure (New York Heart Association Class > 2).

               2. Serious cardiac arrhythmia.

               3. Myocardial infarction ≤ 6 months.

               4. Unstable angina.

          -  Prior clinically significant allergic reaction to chimerized or murine monoclonal
             antibody therapy.

          -  Prior treatment ≤ 6 months with cetuximab, panitumomab, gefitinb, erlotinib, or other
             therapy that specifically and directly targets the EGF pathway.

          -  Anticancer therapy or investigational agents for nonmalignant disease ≤ 4 weeks or 5
             half-lives, whichever is shorter, prior to Cycle 1 Day 1, with the exception of
             tamoxifen for patients with a history of operated breast cancer > 3 years and no
             evidence of disease after surgery.

          -  Major surgery ≤ 4 weeks.

          -  Clinically significant psychiatric illness, other comorbidity, or laboratory
             abnormality that, in the opinion of the Investigator, makes it unsafe for the patient
             to participate in the study or may interfere with study compliance or study results.

          -  Other unspecified reasons that, in the opinion of the Investigator, make the patient
             unsuitable for enrollment.
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:ZZ06 AEs
Time Frame:up to 36 weeks
Safety Issue:
Description:Adverse events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events v5.0

Secondary Outcome Measures

Measure:PK parameters: Area under curve (AUC)
Time Frame:up to 28 weeks
Safety Issue:
Description:According to the test schedule, the blood volume of each subject's PK was analyzed and PK analysis was performed.
Measure:PK parameters: Cmax
Time Frame:up to 28 weeks
Safety Issue:
Description:According to the test schedule, the blood volume of each subject's PK was analyzed and PK analysis was performed.
Measure:PK parameters: Clearance rate (CL)
Time Frame:up to 28 weeks
Safety Issue:
Description:According to the test schedule, the blood volume of each subject's PK was analyzed and PK analysis was performed.
Measure:PK parameters: t1/2
Time Frame:up to 28 weeks
Safety Issue:
Description:According to the test schedule, the blood volume of each subject's PK was analyzed and PK analysis was performed.
Measure:PK parameters: Vz
Time Frame:up to 28 weeks
Safety Issue:
Description:According to the test schedule, the blood volume of each subject's PK was analyzed and PK analysis was performed.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Changchun Intellicrown Pharmaceutical Co. LTD

Trial Keywords

  • treatment-emergent adverse event (TEAE)
  • dose limiting toxicity (DLT)
  • pharmacokinetic (PK)
  • antidrug antibodies (ADA)

Last Updated

April 14, 2021