ZZ06 in Adult Patients With Advanced Solid Tumor Malignancies

NCT04412616 | Recruiting Phase 1 FDA Drug

• 1 other identifier: ZZ06-2020A
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 5

Brief Summary

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.

Conditions

Advanced EGFR Positive Solid Tumor

Keywords

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

Outcome Measures

Primary Outcomes (3)

• ZZ06 AEs

  Adverse events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events v5.0

  up to 36 weeks

• Incidence of abnormal laboratory test results

  The data of the clinical laboratory evaluation is collected and analyzed according to the time point of the test flow chart

  up to 36 weeks

• Incidence of abnormal physical exam findings

  The data of the physical examinations is collected and analyzed according to the time point of the test flow chart

  up to 36 weeks

Secondary Outcomes (5)

• PK parameters: Area under curve (AUC)

  up to 28 weeks

• PK parameters: Cmax

  up to 28 weeks

• PK parameters: Clearance rate (CL)

  up to 28 weeks

• PK parameters: t1/2

  up to 28 weeks

• PK parameters: Vz

  up to 28 weeks

Study Arms (7)

ZZ06 0.03 mg/kg dose group

EXPERIMENTAL

ZZ06 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.

Biological: ZZ06

ZZ06 0.06 mg/kg dose group

EXPERIMENTAL

ZZ06 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.

Biological: ZZ06

ZZ06 0.12 mg/kg dose group

EXPERIMENTAL

ZZ06 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.

Biological: ZZ06

ZZ06 0.22 mg/kg dose group

EXPERIMENTAL

ZZ06 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.

Biological: ZZ06

ZZ06 0.39 mg/kg dose group

EXPERIMENTAL

ZZ06 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.

Biological: ZZ06

ZZ06 0.70 mg/kg dose group

EXPERIMENTAL

ZZ06 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.

Biological: ZZ06

ZZ06 1.00 mg/kg dose group

EXPERIMENTAL

ZZ06 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.

Biological: ZZ06

Interventions

ZZ06 BIOLOGICAL

The phase I "3 + 3" study design was used in dose escalation from low dose to high dose to determine the MTD.Sequential assignment of Patient cohorts to one of five dose levels of ZZ06 : 0.03mg/kg,0.06mg/kg,0.12mg/kg,0.22mg/kg,0.39mg/kg,0.70mg/kg,1 mg/kg.

ZZ06 0.03 mg/kg dose group; ZZ06 0.06 mg/kg dose group; ZZ06 0.12 mg/kg dose group; ZZ06 0.22 mg/kg dose group; ZZ06 0.39 mg/kg dose group; ZZ06 0.70 mg/kg dose group; ZZ06 1.00 mg/kg dose group

Eligibility Criteria

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

You may qualify if:

• 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:
• Bone marrow： ANC ≥ 1500 cells/mm3； Platelet count ≥ 75 000 cells/mm3； Hemoglobin ≥ 8.0 g/dL.
• Coagulation： Prothrombin time ≤ 1.5× ULN； Activated partial thromboplastin time ≤ 1.5× ULN；
• Renal function： Serum creatinine ≤ 1.5× ULN ； estimated glomerular filtration rate≥ 60 mL/min (Cockcroft-Gault formula).
• 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.

You may not qualify if:

• 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:
• Congestive heart failure (New York Heart Association Class \> 2).
• Serious cardiac arrhythmia.
• Myocardial infarction ≤ 6 months.
• 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.

Sponsors & Collaborators

• Changchun Intellicrown Pharmaceutical Co. LTD: lead
• Covance: collaborator

Study Sites (5)

Cedars Sinai Medical Center

Los Angeles, California, 90048-1804, United States

RECRUITING

Kansas University Cancer Center

Fairway, Kansas, 66205-2528, United States

RECRUITING

Montefiore Medical Center

The Bronx, New York, 90048-1804, United States

RECRUITING

Jilin Cancer Hospital

Changchun, Jilin, 130000, China

NOT YET RECRUITING

The first Bethune hospital of Jilin University

Changchun, Jilin, 130021, China

RECRUITING

Study Officials

• Sanjay Goel, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shiqi Bai

CONTACT

18943642700; baishiqi@intelli-crown.com

Study Design

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

Study Record Dates

• First Submitted: May 14, 2020
• First Posted: June 2, 2020
• Study Start: September 1, 2020
• Primary Completion: December 1, 2025
• Study Completion (Estimated): July 6, 2026
• Last Updated: June 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2); US (3)