A Study of EP0031 in Patients With Advanced RET-altered Malignancies
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ClinicalTrials.gov Identifier: NCT05443126 |
Recruitment Status :
Recruiting
First Posted : July 5, 2022
Last Update Posted : April 19, 2024
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Advanced Solid Tumor | Drug: EP0031 | Phase 1 Phase 2 |
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 |
Actual Study Start Date : | September 30, 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) |
- Module A: Incidence of Dose-limiting Toxicity (DLTs ) during the first 28 days of EP0031 treatment [ Time Frame: First 28 days of treatment ]
- Modules B and C: Overall Response Rate (ORR) as measured using RECIST v1.1 [ Time Frame: 12 months ]
- Area under the plasma concentration versus time curve (AUC) [ Time Frame: First 48 hours after drug administered ]To characterise the pharmacokinetics (PK) of EP0031
- Maximum Plasma Concentration (Cmax) [ Time Frame: First 24 hours after drug administered ]To characterise the pharmacokinetics (PK) of EP0031
- 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
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Applicable to all patients:
- Must be ≥18 years of age at the time of informed consent, with documented RET-altered malignancy
- Patients should be well informed and consented about alternative treatment options including approved RET-targeted therapies
- ECOG performance status of 0 or 1 at screening
- 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:
- Any known major driver gene alterations other than RET.
- Spinal cord compression or brain metastases. Patients with stable brain metastases can be enrolled.
- Active infection requiring systemic antibiotic, antifungal, or antiviral medication
- Severe or uncontrolled medical condition or psychiatric condition
- Chronic glomerulonephritis or renal transplant
- Patients with active hepatitis B infection or active hepatitis C
- 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
- Receipt of any strong inhibitor or inducer of CYP3A4
- Impaired hepatic or renal function, inadequate bone marrow reserve or organ function
- 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
- Uncontrolled hypertension
- Corneal ulceration at screening
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
Contact: Sonia Serrano | +44 (0)20 3743 0992 | sonia@ellipses.life | |
Contact: Liz Clark | +44 (0)20 3743 0992 | Liz@ellipses.life |
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: | April 19, 2024 |
Last Verified: | April 2024 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
selective RET-inhibitor |
Neoplasms |