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Status:

RECRUITING

ZZ06 in Adult Patients With Advanced Solid Tumor Malignancies

Lead Sponsor:

Changchun Intellicrown Pharmaceutical Co. LTD

Collaborating Sponsors:

Covance

Conditions:

Advanced EGFR Positive Solid Tumor

Eligibility:

All Genders

18+ years

Phase:

PHASE1

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 Mal...

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-emerg...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

  • 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.

Key Trial Info

Start Date :

September 1 2020

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

July 6 2026

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT04412616

Start Date

September 1 2020

End Date

July 6 2026

Last Update

June 10 2025

Active Locations (5)

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Page 1 of 2 (5 locations)

1

Cedars Sinai Medical Center

Los Angeles, California, United States, 90048-1804

2

Kansas University Cancer Center

Fairway, Kansas, United States, 66205-2528

3

Montefiore Medical Center

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

4

Jilin Cancer Hospital

Changchun, Jilin, China, 130000