Solid CancersPhase 1/2NCT07030478
A Study to Evaluate the Safety and Tolerability of EP0089
A Phase 1/2 study testing EP0089-101 in people with Solid Cancers and Solid Tumours, run by Ellipses Pharma.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Cancers, Solid Tumours
- What is being tested?
- EP0089-101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Jun 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Adequate hepatic, haematological and renal function as assessed by protocol-defined criteria.
- Additional cohort/disease specific criteria apply
- Measurable disease per RECIST v1.1
Who cannot join
- 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.
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- 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
- 9. Current active, or history of, autoimmune disease that requires or required continuous treatment within 2 years prior to starting study treatment
- 10. 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.
- 11. 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.
- 12. One or more clinically significant (ie, active) cardiovascular diseases, myocardial infarction, or unstable angina (≤ 6 months prior to first administration of study drug)
About this study
Official title: A Phase I/IIa Study to Evaluate the Safety and Tolerability of Monoclonal Antibody EP0089 in Patients With Advanced Solid Tumours
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
- Being tested
- EP0089-101
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EP0089-101Drug
EP0089 will be initially administered by intravenous (IV) infusion once every 2 weeks (Q2W)
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | 3+3 design evaluating the safety and efficacy of EP0089 Receives: Drug: EP0089-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 126 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study startSep 2025 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid CancersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ellipses Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07030478
- Sponsor's protocol ID
- EP0089-101
- Status last verified
- Jun 2025
- First submitted
- 30 May 2025
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa Study to Evaluate the Safety and Tolerability of Monoclonal Antibody EP0089 in Patients With Advanced Solid Tumours
- ClinicalTrials.gov ID
- NCT07030478
- Acronym / sponsor ID
- EP0089-101
- Conditions
- Solid Cancers, Solid Tumours
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Ellipses PharmaIndustry (pharma, biotech, devices)
- Study start
- Sep 2025 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 22 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Drug: EP0089-1013+3 design evaluating the safety and efficacy of EP0089 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EP0089-101EP0089 will be initially administered by intravenous (IV) infusion once every 2 weeks (Q2W) | Drug | Dose Escalation |
Primary outcome
Safety and Tolerability of EP0089
Time frame: 126 weeks
The study's main goal is to find the highest safe dose of EP0089 and the best dose for future testing.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing EP0089-101 in people with Solid Cancers and Solid Tumours, run by Ellipses Pharma.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability of EP0089 (time frame: 126 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2025.