The Bronx, NYNCT04412616Now EnrollingIRB Ready

Advanced EGFR Positive Solid Tumor Clinical Trial in The Bronx, NY

Access cutting-edge advanced egfr positive solid tumor treatment through this phase 1 clinical trial at a research site in The Bronx. Study-provided care at no cost to qualified participants.

Sponsored by Changchun Intellicrown Pharmaceutical Co. LTD

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Expert Care in The Bronx

Access advanced egfr positive solid tumor specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related advanced egfr positive solid tumor treatment provided free

Apply for This The Bronx Location

Check if you qualify for this advanced egfr positive solid tumor clinical trial in The Bronx, NY

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to The Bronx

    Convenient for NY residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit The Bronx site if eligible
  4. 4Begin participation

About This Advanced EGFR Positive Solid Tumor Study in The Bronx

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.

Sponsor: Changchun Intellicrown Pharmaceutical Co. LTD

Who Can Participate

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:
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 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:
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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in The Bronx?

Yes, this clinical trial (NCT04412616) has an active research site in The Bronx, NY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Advanced EGFR Positive Solid Tumor Treatment Options in The Bronx, NY

If you're searching for advanced egfr positive solid tumor treatment options in The Bronx, NY, this clinical trial (NCT04412616) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our The Bronx research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced advanced egfr positive solid tumor specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all advanced egfr positive solid tumor clinical trials near you to find additional studies recruiting in your area.

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