This phase I/II study is trying to determine the best dose level, safety and tolerability of an oral targeted therapy (EO1001) in people with advanced EGFR, HER2 or HER4 positive cancer.
This trial is treating patients with ErbB-1(EGFR), ErbB-2(HER2), or ERbB-4(HER4) positive advanced or metastatic cancer.
This is a systemic therapy trial.
You may be able to join this trial if:
- You are able to swallow medication by mouth.
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- You have had treatment, but your cancer has come back.
- Your cancer has not spread to other parts of the body.
- Your cancer has spread to other parts of the body.
You may be excluded from this trial if:
- You have a certain disease or psychological condition.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.
Clinical Summary Read More
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An ascending single and multiple dose study of the safety, tolerability, pharmacokinetics and anti-tumour activity of once-daily oral treatment with EO1001 in patients with advanced cancer.
This trial has two tiers or phases. Tier 1A and 1B is aiming to determine the appropriate dose level of EO1001. Cycle 1: Patients will receive a single dose of oral EO1001 on day 1 and single dose pharmacokinetics will be performed at nominated time points for 7 days. Beginning on day 8, oral EO1001 will be administered once daily for 21 days. Multi-dose pharmacokinetics will be performed at the nominated time points. Cycles 2-6: Oral EO1001 will be administered once daily in continuous 28-day cycles for up to 20 weeks. Multi-dose pharmacokinetics will be performed at the nominated time points. Following Cycle 6, participants without DLT or disease progression may be offered continued treatment in an extension protocol upon recommendation of the principal investigator. Tier 2 (MTD Expansion) will begin when the Safety Review Committee states that a Maximum Tolerated Dose (MTD) has been reached. At that stage, additional participants will be recruited to the MTD dose.
Recruiting Hospitals Read More