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Not yet recruitingNCT07030478Updated Jun 22, 2025

A Study to Evaluate the Safety and Tolerability of EP0089

A Phase 1/2 interventional study of EP0089-101 in Solid Cancers and Solid Tumours, sponsored by Ellipses Pharma. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-22.

Sponsored by Ellipses Pharma · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
190
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Solid Cancers
  • Solid Tumours
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In context

Lead sponsor

Ellipses Pharma is the lead sponsor of 6 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Applicable to all patients:

  1. 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
  2. ECOG performance status of 0 or 1 and life expectancy >3 months at screening
  3. Ability to understand and provide written informed consent
  4. Must be willing to comply with necessary contraceptive methods as required
  5. Willing and able to comply with the scheduled study treatment plan, laboratory tests, and other study procedures.
  6. Adequate hepatic, haematological and renal function as assessed by protocol-defined criteria.
  7. Additional cohort/disease specific criteria apply
  8. Measurable disease per RECIST v1.1

Exclusion criteria

Exclusion Criteria:

  1. Known active CNS metastases and/or leptomeningeal disease and/or carcinomatous meningitis.
  2. Recent major surgery
  3. Recent live or live-attenuated vaccine ≤ 30 days prior to the first dose
  4. 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.
  5. Prior severe hypersensitivity reaction to mAbs
  6. Previous > Grade 2 peripheral neuropathy.
  7. 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
  1. Current active, or history of, autoimmune disease that requires or required continuous treatment within 2 years prior to starting study treatment
  1. 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.
  1. 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.
  1. One or more clinically significant (ie, active) cardiovascular diseases, myocardial infarction, or unstable angina (≤ 6 months prior to first administration of study drug)
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
190 participants (estimated)

Study arms

  • Experimental
    Dose Escalation

    3+3 design evaluating the safety and efficacy of EP0089

    Drug: EP0089-101

Interventions

  • DrugEP0089-101

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

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What researchers measure

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.

    Time frame: 126 weeks

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07030478
Lead sponsor
Ellipses Pharma
Responsible party
Sponsor
First posted
Jun 22, 2025
Start date
Sep 2025 (estimated)
Primary completion
Mar 2028 (estimated)
Completion
Jun 2029 (estimated)
Last update
Jun 22, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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