Advanced Solid Tumor (Phase 1)Phase 1NCT07163325
EP102 Safety and Efficacy in METTL3 Modulation in Advanced Solid Tumors
A Phase 1 study testing EP102 in people with Advanced Solid Tumor (Phase 1), run by Epics Therapeutics at 11 sites in 4 countries.
Trial summary
This the first-in-human (FIH) study for the Investigational Medicinal Product (IMP) EP102, is designed to explore the maximum tolerated dose (MTD), the overall safety profile, its pharmacokinetic (PK) / pharmacodynamic (PD) profile, and an exploratory evaluation of antitumor activity in participants with advanced… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor (Phase 1)
- What is being tested?
- EP102
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 11 sitesin 4 countries
- Study dates
- 24 Jul 2025to Nov 2028
- Phase
- Phase 1
- 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
- Participants must have a histological diagnosis of locally advanced or metastatic malignant solid tumors of one of the following cancer types:
- ovarian cancer
- cervical cancer
- endometrial cancer
- testicular cancer
- cholangiocarcinoma
Show all 24Show fewer
- thyroid cancer
- parathyroid cancer
- adrenal cancer
- pancreatic cancer
- non-small-cell lung cancer (NSCLC)
- head-and neck cancer
- renal cell cancer
- urethral cancer
- bladder cancer
- colorectal cancer
- gastric cancer
- esophageal cancer
- triple-negative breast cancer
- thymoma
- soft tissue sarcoma
- Participants must have failed (i.e. progressed on, or been intolerant to standard treatment), or no standard treatment must exist, or they must have refused standard treatment. All participants must have received at least one prior line of systemic therapy.
- Participants must have at least one measurable lesion per RECIST v1.1.
- Participant must have a life expectancy of at least 12 weeks.
Who cannot join
- Participants with an active severe infection or unexplained fever > 38.5°C during screening or on the first day of study drug administration are excluded. However, at the Investigator's discretion, participants with tumor-related fever may be enrolled.
- Participants with known human immunodeficiency virus (HIV) infection, active hepatitis B virus (HBV) infection (hepatitis B surface antigen (HBsAg) positive in serum), or active hepatitis C virus (HCV) infection (HCV RNA positive in serum).
- Participants with known dysphagia, short-bowel syndrome, gastroparesis, or any condition that may impair the ingestion or gastrointestinal absorption of orally administered drugs.
- Pregnant or breastfeeding participants.
- Participants who have received IMP or devices in other clinical trials within four weeks before the first dose.
- Participants with prior exposure to selective METTL3 inhibitor therapy.
Trial locations and contacts
11 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
11 sites in 4 countries
Belgium4 sites, 4 recruiting
- Recruiting
Institut Jules Bordet
Brussels, 1070
Principal investigator, +32 2 541 31 11, info@epicstx.com
- Recruiting
Cliniques universitaires Saint-Luc
Brussels, 1200
Principal investigator, +32 2 764 11 11, info@epicstx.com
- Recruiting
Universitair Ziekenhuis Gent (UZ Gent) - Drug Research Unit Gent (DRUG)
Ghent, 9000
Principal investigator, + 32 9 332 00 00, info@epicstx.com
- Recruiting
Leuven Cancer Institute (LKI)
Leuven, 3000
Principal investigator, + 32 16 34 13 68, info@epicstx.com
Spain3 sites, 3 recruiting
- Recruiting
Hospital Universitari Vall d'Hebron - Vall d'Hebron Institute of Oncology
Barcelona, 8035
Principal Investigator, +34 932 54 34 50, info@epicstx.com
- Recruiting
START Madrid - CIOCC
Madrid, 28050
Principal Investigator, +34 91 756 78 25, info@epicstx.com
- Recruiting
Hospital Universitario de Santiago de Compostela
Santiago de Compostela, 15706
Principal investigator, +34 981 95 00 00, info@epicstx.com
Czechia2 sites, 2 recruiting
- Recruiting
Masaryk Memorial Cancer Institute
Brno, 656 53
Principal Investigator, +420 543 131 111, info@epicstx.com
- Recruiting
Olomouc University Hospital
Olomouc, 77900
Principal Investigator, +420 585 851 111, info@epicstx.com
Netherlands2 sites, 2 recruiting
- Recruiting
Netherlands Cancer Institute (NKI)
Amsterdam, 1066 CX
Principal investigator, +31 20 512 9111, info@epicstx.com
- Recruiting
University Medical Center Groningen, University of Groningen Department of Medical Oncology
Groningen, 9713 GZ
Principal Investigator, +31 50 361 28 21, info@epicstx.com
About this study
Official title: A Phase 1 Multicenter, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered EP102 Monotherapy in Participants With Advanced Solid Tumors
This the first-in-human (FIH) study for the Investigational Medicinal Product (IMP) EP102, is designed to explore the maximum tolerated dose (MTD), the overall safety profile, its pharmacokinetic (PK) / pharmacodynamic (PD) profile, and an exploratory evaluation of antitumor activity in participants with advanced solid tumors, who have no available standard therapy or who have failed standard therapies.
This study will inform on recommended doses for further studies, e.g. dose optimization studies and / or efficacy and safety studies.
- Conditions
- Advanced Solid Tumor (Phase 1)
- Being tested
- EP102
- Keywords
- Advanced Solid Tumors, EP102
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EP102Drug
EP102 will be administered orally
| Study group | Role | What they receive |
|---|---|---|
| EP102 Dose level 1 | Experimental | Not described Receives: Drug: EP102 |
| EP102 Dose level 2 | Experimental | Not described Receives: Drug: EP102 |
| EP102 Dose level 3 | Experimental | Not described Receives: Drug: EP102 |
| EP102 Dose level 4 | Experimental | Not described Receives: Drug: EP102 |
| EP102 Dose level 5 | Experimental | Not described Receives: Drug: EP102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety and tolerability of EP102 monotherapy
The incidence of adverse drug reactions (ADRs) and serious adverse drug reactions (SARs) during study period
Measured: Up to 21 Days after first administration
To assess the safety and tolerability of EP102 monotherapy
The incidence of all treatment-emergent AEs and treatment-emergent serious adverse events (SAEs) during study period
Measured: Up to 21 Days after first administration
Explore the maximum tolerated dose (MTD) and recommended doses of EP102 monotherapy for subsequent studie
Incidence of Dose Limiting Toxicities (DLT)
Measured: Up to 21 Days after first administration
Secondary outcomes (6)
To characterize the pharmacokinetic (PK) profile of EP102
Peak Plasma Concentration (Cmax)
Measured: Up to 21 days after first administration
To characterize the pharmacokinetic (PK) profile of EP102
Area under the plasma concentration versus time curve (AUC)
Measured: Up to 21 Days after first administration
To characterize the pharmacokinetic (PK) profile of EP102
EP102 Halflife (t1/2)
Measured: Up to 21 Days after first administration
To characterize the pharmacokinetic (PK) profile of EP102
Clearance (Cl)
Measured: Up to 21 Days after first administration
To characterize the pharmacokinetic (PK) profile of EP102
Volume of Distribution (Vd)
Measured: Up to 21 Days after first administration
To preliminarily evaluate the anti-tumor activity pharmacodynamic (PD) of EP102 monotherapy
Efficacy evaluations for confirmed and unconfirmed tumor responses: determined according to RECIST v1.1 criteria
Measured: Up to 21 days after administration and up until study end
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start24 Jul 2025
- Primary completionNov 2027 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid Tumor (Phase 1)Studies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- The study will follow a Bayesian optimal interval (BOIN) design.
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Epics Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07163325
- Sponsor's protocol ID
- EP102-101
- Status last verified
- Jun 2026
- First submitted
- 5 Aug 2025
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The sponsor will establish which IPD will be shared after the analysis of the study results
Publications
Dutheuil G, Oukoloff K, Korac J, Lenoir F, El Bousmaqui M, Probst N, Lapin A, Nakhabina G, Sorlet C, Parmentier N, Karila D, Ghavtadze N, Casault P, Claridge S, Sapmaz S, Slater MJ, Fraser GL. Discovery, Optimization, and Preclinical Pharmacology of EP652, a METTL3 Inhibitor with Efficacy in Liquid and Solid Tumor Models. J Med Chem. 2025 Feb 13;68(3):2981-3003. doi: 10.1021/acs.jmedchem.4c02225. Epub 2025 Jan 30.
PubMed 39883878Abbad L, Chatziantoniou C. Discovering New Therapies for Kidney Fibrosis: The Promise of Epigenetic and Epitranscriptomic Modulation. J Am Soc Nephrol. 2026 Jul 1;37(7):1367-1369. doi: 10.1681/ASN.0000001136. Epub 2026 May 28. No abstract available.
PubMed 42210870
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Multicenter, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered EP102 Monotherapy in Participants With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07163325
- Acronym / sponsor ID
- EP102-101
- Conditions
- Advanced Solid Tumor (Phase 1)
- Keywords
- Advanced Solid Tumors, EP102
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Epics TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 24 Jul 2025 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 9 Sep 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 the first-in-human (FIH) study for the Investigational Medicinal Product (IMP) EP102, is designed to explore the maximum tolerated dose (MTD), the overall safety profile, its pharmacokinetic (PK) / pharmacodynamic (PD) profile, and an exploratory evaluation of antitumor activity in participants with advanced solid tumors, who have no available standard therapy or who have failed standard therapies.
This study will inform on recommended doses for further studies, e.g. dose optimization studies and / or efficacy and safety studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- The study will follow a Bayesian optimal interval (BOIN) design.
| Arm | Type | Receives |
|---|---|---|
| EP102 Dose level 1 | Experimental | Drug: EP102 |
| EP102 Dose level 2 | Experimental | Drug: EP102 |
| EP102 Dose level 3 | Experimental | Drug: EP102 |
| EP102 Dose level 4 | Experimental | Drug: EP102 |
| EP102 Dose level 5 | Experimental | Drug: EP102 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Participants must have a histological diagnosis of locally advanced or metastatic malignant solid tumors of one of the following cancer types:
- Participants must have failed (i.e. progressed on, or been intolerant to standard treatment), or no standard treatment must exist, or they must have refused standard treatment. All participants must have received at least one prior line of systemic therapy.
- Participants must have at least one measurable lesion per RECIST v1.1.
- Participant must have a life expectancy of at least 12 weeks.
Key exclusion criteria (6 listed)
- Participants with an active severe infection or unexplained fever > 38.5°C during screening or on the first day of study drug administration are excluded. However, at the Investigator's discretion, participants with tumor-related fever may be enrolled.
- Participants with known human immunodeficiency virus (HIV) infection, active hepatitis B virus (HBV) infection (hepatitis B surface antigen (HBsAg) positive in serum), or active hepatitis C virus (HCV) infection (HCV RNA positive in serum).
- Participants with known dysphagia, short-bowel syndrome, gastroparesis, or any condition that may impair the ingestion or gastrointestinal absorption of orally administered drugs.
- Pregnant or breastfeeding participants.
- Participants who have received IMP or devices in other clinical trials within four weeks before the first dose.
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 |
|---|---|---|
| EP102EP102 will be administered orally | Drug | EP102 Dose level 1, EP102 Dose level 2, EP102 Dose level 3, EP102 Dose level 4, EP102 Dose level 5 |
Primary outcome
To assess the safety and tolerability of EP102 monotherapy
Time frame: Up to 21 Days after first administration
The incidence of adverse drug reactions (ADRs) and serious adverse drug reactions (SARs) during study period
To assess the safety and tolerability of EP102 monotherapy
Time frame: Up to 21 Days after first administration
The incidence of all treatment-emergent AEs and treatment-emergent serious adverse events (SAEs) during study period
Explore the maximum tolerated dose (MTD) and recommended doses of EP102 monotherapy for subsequent studie
Time frame: Up to 21 Days after first administration
Incidence of Dose Limiting Toxicities (DLT)
6 secondary outcomes
To characterize the pharmacokinetic (PK) profile of EP102
Time frame: Up to 21 days after first administration
To characterize the pharmacokinetic (PK) profile of EP102
Time frame: Up to 21 Days after first administration
To characterize the pharmacokinetic (PK) profile of EP102
Time frame: Up to 21 Days after first administration
To characterize the pharmacokinetic (PK) profile of EP102
Time frame: Up to 21 Days after first administration
To characterize the pharmacokinetic (PK) profile of EP102
Time frame: Up to 21 Days after first administration
To preliminarily evaluate the anti-tumor activity pharmacodynamic (PD) of EP102 monotherapy
Time frame: Up to 21 days after administration and up until study end
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 11 Jun 2026.
- Background: PubMed 39883878Dutheuil G, Oukoloff K, Korac J, Lenoir F, El Bousmaqui M, Probst N, Lapin A, Nakhabina G, Sorlet C, Parmentier N, Karila D, Ghavtadze N, Casault P, Claridge S, Sapmaz S, Slater MJ, Fraser GL. Discovery, Optimization, and Preclinical Pharmacology of EP652, a METTL3 Inhibitor with Efficacy in Liquid and Solid Tumor Models. J Med Chem. 2025 Feb 13;68(3):2981-3003. doi: 10.1021/acs.jmedchem.4c02225. Epub 2025 Jan 30.
- Derived from this study: PubMed 42210870Abbad L, Chatziantoniou C. Discovering New Therapies for Kidney Fibrosis: The Promise of Epigenetic and Epitranscriptomic Modulation. J Am Soc Nephrol. 2026 Jul 1;37(7):1367-1369. doi: 10.1681/ASN.0000001136. Epub 2026 May 28. No abstract available.
- Individual participant dataSharing planned: Yes. The sponsor will establish which IPD will be shared after the analysis of the study results
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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.
11 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EP102 in people with Advanced Solid Tumor (Phase 1), run by Epics Therapeutics at 11 sites in 4 countries.
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 24 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Belgium, Spain, Czechia, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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 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.
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?
Contact Clinical Trial Liaison (+32 71 348 500, info@epicstx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the safety and tolerability of EP102 monotherapy (time frame: Up to 21 Days after first administration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07163325, which also lists 2 linked publications.
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 11 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.