A Study to Evaluate the Safety and Tolerability of EP0089

NCT07030478 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: EP0089-101
• Study Type: interventional
• Target: 190
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a first-in-human (FIH), first-in-class, Phase I/IIa, open-label study designed to evaluate the safety and tolerability of EP0089 (study drug). Study drug will initially be given via intravenous (IV) infusion once every 2 weeks (Q2W), with one treatment cycle defined as 14 days. The study will enroll patients with advanced solid tumours for whom no standard therapy exists or for whom standard therapy has failed. An independent Safety Monitoring Committee (SMC) will review safety data at regular intervals to ensure participant safety and support dose escalation decisions.

Conditions

Solid Cancers; Solid Tumours

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability of EP0089

  The study's main goal is to find the highest safe dose of EP0089 and the best dose for future testing.

  126 weeks

Study Arms (1)

Dose Escalation

EXPERIMENTAL

3+3 design evaluating the safety and efficacy of EP0089

Drug: EP0089-101

Interventions

EP0089-101 DRUG

EP0089 will be initially administered by intravenous (IV) infusion once every 2 weeks (Q2W)

Dose Escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Applicable to all patients:
• Must be ≥18 years of age (≥19 in South Korea) with documented recurrent, metastatic or unresectable solid tumours for whom no standard therapy exists or standard therapy has failed
• ECOG performance status of 0 or 1 and life expectancy \>3 months at screening
• Ability to understand and provide written informed consent
• Must be willing to comply with necessary contraceptive methods as required
• Willing and able to comply with the scheduled study treatment plan, laboratory tests, and other study procedures.
• Adequate hepatic, haematological and renal function as assessed by protocol-defined criteria.
• Additional cohort/disease specific criteria apply
• Measurable disease per RECIST v1.1

You may not qualify if:

• Known active CNS metastases and/or leptomeningeal disease and/or carcinomatous meningitis.
• Recent major surgery
• Recent live or live-attenuated vaccine ≤ 30 days prior to the first dose
• Current active, or history of, autoimmune disease that requires or required systemic treatment (ie, with disease modifying agents, corticosteroids, or immunosuppressive drugs) within 2 years prior to starting study treatment.
• Prior severe hypersensitivity reaction to mAbs
• Previous \> Grade 2 peripheral neuropathy.
• Significant neurological condition eg stroke, transient ischaemic attack (in the last 12 months), epilepsy, head trauma, brain surgery or prior history of any significant psychiatric disorder
• \. Current active, or history of, autoimmune disease that requires or required continuous treatment within 2 years prior to starting study treatment
• \. Receiving chronic systemic steroid therapy (\> 10 mg /day of prednisone or equivalent) or any other form of immunosuppressive therapy ≤ 7 days prior the first dose of study drug. Topical or inhaled steroids are permitted.
• \. Any prior immune-mediated or immune-related adverse events related to treatment with immune-modulatory agents that caused permanent discontinuation of the agent, that were ≥ Grade 3 in severity or in the opinion of the Investigator would otherwise jeopardise patient safety in this study.
• \. One or more clinically significant (ie, active) cardiovascular diseases, myocardial infarction, or unstable angina (≤ 6 months prior to first administration of study drug)

Sponsors & Collaborators

• Ellipses Pharma: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: N/A - is an open label study
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The trial is open-label with dose-escalation, and dose optimisation/expansion components to evaluate the safety, tolerability, and preliminary anti-tumour activity of EP0089. The starting dose and schedule for the planned dose escalations have been carefully selected based on preclinical data, and in line with relevant regulatory standards, using a standard 3+3 dose escalation design for all dose levels with the exception of dose level 1 which will apply to a single patient only. Specific safety evaluations are included to evaluate potential toxicities identified in preclinical toxicity studies. The study also includes a thorough assessment of PK/PD and evaluation of the impact of biomarkers to evaluate potential patient selection strategies and establish proof of mechanism.

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: June 22, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share