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RecruitingLast updated: 29 November 2023

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 cancerAn 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.

Clinical summary

Summary

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.

Conditions

This trial is treating patients with ErbB-1(EGFR), ErbB-2(HER2), or ERbB-4(HER4) positive advanced or metastatic cancer

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I/II

More information

Trial Identifiers

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Trial sponsor

Senz Oncology

Scientific Title

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.

Eligibility

Inclusion

• Male or female >= 18 years of age participants with confirmed diagnosis of metastatic or advanced stage ErbB-1 (EGFR), ErbB-2 (HER2) and/or ERbB-4 (HER4) positive cancer who have relapsed after treatment with approved therapies and are unsuitable for further treatment with approved therapies or declined further treatment with approved therapies.
• Participants must sign informed consent.
• Participants must have measurable disease, defined as at least 1 unidimensional measurable lesion on an imaging scan as defined by RECIST 1.1.
• Life expectancy of greater than 3 months.
• Acceptable organ function, as evidenced by the following laboratory data during screening period:
• Adequate hepatic function as defined by bilirubin less than or equal to 1.5 x the upper limit of normal (ULN) and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 2.5 x ULN. Serum bilirubin must be less than or equal to 2.5 mg/dL when increase is clearly documented as due to Gilbert’s syndrome.
• Adequate renal function, with serum creatinine less than or equal to 1.5 x ULN or MDRD greater than or equal to 60 mL/min (CKD EPI Creatinine Equation).
o CNS metastases that have been treated by complete resection and/or radiotherapy demonstrating stability or improvement may be enrolled provided they are stable as shown by CT/MRI scan at least 4 weeks before screening without evidence of cerebral oedema.
o Patients with CNS metastases requiring corticosteroids or anticonvulsants must be on a stable or declining dose for a minimum of 10 days prior to cycle 1 day 1
o Patients with leptomeningeal disease may be allowed in the study in agreement with sponsor and medical monitor.

Exclusion

• Active infection requiring systemic treatment, defined as requiring antimicrobial, antifungal, or antiviral agents.
• Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol.
• Untreated or symptomatic brain metastases. Participants with treated or untreated brain metastases are NOT eligible if there has been a change in brain disease status in the 8 weeks prior to screening. This includes evidence of radiological progression, clinical decline and increasing steroid dose.
• Current or recent (within 10 days of Cycle 1 Day 1) use of full dose oral or parenteral anticoagulants or other thrombolytic agents for therapeutic (as opposed to prophylactic) purposes, clinically serious non-healing wounds, or incompletely healed bone fracture.
• Participants on > 2mg dexamethasone (or steroid equivalent).
• Ventriculoperitoneal (VP) shunts.
• Renal compromised or renal failure.
• Hepatic compromised or hepatic failure.
• Bullous and exfoliative skin disorders.
• Interstitial lung disease (ILD)
• Participants with adequate cardiac function ( less than or equal to NYHA class II) or normal cardiac function with left ventricular ejection fraction (LVEF) less than or equal to 50% at screening.
• Anticancer therapy within 4 weeks, or a minimum of 5 half-lives whichever is longer.
• Pregnancy or breast-feeding.
• Inability to swallow oral medications or having malabsorption syndrome.
• Unresolved adverse reactions to prior treatments NCI CTCAEv5 > Grade 1.
• Any serious medical or psychiatric conditions which the Investigator feels may interfere with the patient’s ability to give informed consent or participate in the procedures or evaluations of the study.
• Abnormal coagulation not corrected by plasma infusion (APTT > ULN or INR> 1.2).
• Participants of childbearing potential who do not agree to use at least 2 effective contraceptive methods throughout the study and for 6 months following completion of treatment.
• Female participants who are pregnant or lactating.
• Unstable angina or acute myocardial infarction less than or equal to 6 months prior to starting study treatment.
• Baseline QTc greater than or equal to 470 msec
• Cardiomyopathy.
• Other severe, acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.

Inclusion

  • 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.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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