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A Study of EP0031-101 in Patients With Advanced RET-altered Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05443126
Recruitment Status : Not yet recruiting
First Posted : July 5, 2022
Last Update Posted : July 5, 2022
Sponsor:
Information provided by (Responsible Party):
Ellipses Pharma

Brief Summary:
The aim of this study is to assess the safety, side effects and effectiveness of EP0031 in patients with advanced RET-altered malignancies

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Drug: EP0031 Phase 1 Phase 2

Detailed Description:
EP0031 is being investigated in this modular, interventional Phase I/II dose escalation and dose expansion study to investigate the optimal dose in adult patients with advanced RET-altered malignancies. Currently there are no approved RET-targeted treatments for patients who progress on first-generation SRIs. However, it is proposed that EP0031 can overcome resistance mechanisms to first generation SRIs, as EP0031 is a potent and selective RET inhibitor with broad activity against common RET fusions and mutations.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 265 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Modular, Open-label, Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of EP0031 in Patients With Advanced RET-altered Malignancies
Estimated Study Start Date : September 2022
Estimated Primary Completion Date : December 2026
Estimated Study Completion Date : June 2027

Arm Intervention/treatment
Experimental: RET fusion-positive NSCLC
EP0031 capsules at the recommended phII dose, taken once daily until progressive disease (PD), unacceptable toxicity or patient withdrawal
Drug: EP0031
EP0031 is a potent next-generation selective RET-inhibitor (SRI)

Experimental: RET mutation-positive MTC
EP0031 capsules at the recommended phII dose, taken once daily until progressive disease (PD), unacceptable toxicity or patient withdrawal
Drug: EP0031
EP0031 is a potent next-generation selective RET-inhibitor (SRI)

Experimental: Other RET-altered solid tumours
EP0031 capsules at the recommended phII dose, taken once daily until progressive disease (PD), unacceptable toxicity or patient withdrawal
Drug: EP0031
EP0031 is a potent next-generation selective RET-inhibitor (SRI)

Experimental: RET fusion-positive NSCLC (no prior SRI therapy)
EP0031 capsules at the recommended phII dose, taken once daily until progressive disease (PD), unacceptable toxicity or patient withdrawal
Drug: EP0031
EP0031 is a potent next-generation selective RET-inhibitor (SRI)

Experimental: RET mutation-positive MTC (no prior SRI therapy)
EP0031 capsules at the recommended phII dose, taken once daily until progressive disease (PD), unacceptable toxicity or patient withdrawal
Drug: EP0031
EP0031 is a potent next-generation selective RET-inhibitor (SRI)

Experimental: Other RET-altered solid tumours (no prior SRI therapy)
EP0031 capsules at the recommended phII dose, taken once daily until progressive disease (PD), unacceptable toxicity or patient withdrawal
Drug: EP0031
EP0031 is a potent next-generation selective RET-inhibitor (SRI)




Primary Outcome Measures :
  1. Module A: Incidence of Dose-limiting Toxicity (DLTs ) during the first 28 days of EP0031 treatment [ Time Frame: First 28 days of treatment ]
  2. Modules B and C: Overall Response Rate (ORR) as measured using RECIST v1.1 [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Area under the plasma concentration versus time curve (AUC) [ Time Frame: First 48 hours after drug administered ]
    To characterise the pharmacokinetics (PK) of EP0031

  2. Maximum Plasma Concentration (Cmax) [ Time Frame: First 24 hours after drug administered ]
    To characterise the pharmacokinetics (PK) of EP0031

  3. Time taken for drug concentration to fall from half its original value (Half-life) [ Time Frame: First 72 hours after drug administered ]
    To characterise the pharmacokinetics (PK) of EP0031



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Applicable to all patients:

  1. Must be ≥18 years of age at the time of informed consent, with documented RET-altered malignancy
  2. Patients should be well informed and consented about alternative treatment options including approved RET-targeted therapies
  3. ECOG performance status of 0 or 1 at screening
  4. Ability to understand and provide written informed consent and able to participate in all required evaluations and procedures

Exclusion Criteria:

Patients with any of the following will not be included in the study:

  1. Any known major driver gene alterations other than RET.
  2. Spinal cord compression or brain metastases. Patients with stable brain metastases can be enrolled.
  3. Active infection requiring systemic antibiotic, antifungal, or antiviral medication
  4. Severe or uncontrolled medical condition or psychiatric condition
  5. Chronic glomerulonephritis or renal transplant
  6. Patients with active hepatitis B infection or active hepatitis C
  7. Patients with active HIV infection. Patients living with HIV may be eligible if they have adequate CD4+ T-cell count and no history of AIDS-defining opportunistic infections in the past 12 months
  8. Receipt of any strong inhibitor or inducer of CYP3A4
  9. Impaired hepatic or renal function, inadequate bone marrow reserve or organ function
  10. Any clinically important abnormalities in rhythm, conduction, or morphology on resting ECG or any factor that increases the risk of QTc prolongation or of arrhythmic events , or congestive heart failure Grade II-IV according to the New York Heart Association, myocardial infarction, or unstable angina within the previous 6 months
  11. Uncontrolled hypertension
  12. Corneal ulceration at screening

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05443126


Contacts
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Contact: Liz Clark +44 (0)20 3743 0992 Liz@ellipses.life

Locations
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United States, California
David Geffen School of Medicine at UCLA
Los Angeles, California, United States, 90095
Contact: Andrew Gianoukakis       agianoukakis@lundquist.org   
Sponsors and Collaborators
Ellipses Pharma
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Responsible Party: Ellipses Pharma
ClinicalTrials.gov Identifier: NCT05443126    
Other Study ID Numbers: EP0031-101
First Posted: July 5, 2022    Key Record Dates
Last Update Posted: July 5, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ellipses Pharma:
selective RET-inhibitor
Additional relevant MeSH terms:
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Neoplasms