Solid Tumor, AdultPhase 1NCT04221204
A Monotherapy in Subjects With Advanced Solid Tumors
A Phase 1 study testing Highly selective FGFR1-3 inhibitor in people with Solid Tumor, Adult, run by 3D Medicines (Beijing) Co., Ltd. at 2 sites in 2 countries.
Trial summary
A Phase 1 Study of the Safety, Tolerability, Pharmacokinetics Profiles, and Preliminary Efficacy of 3D185 Monotherapy in Subjects with Advanced Solid Tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Adult
- What is being tested?
- Highly selective FGFR1-3 inhibitor
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Sep 2019to 26 Jun 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Subjects must be male or female and ≥ 18 years of age on the day of enrollment.
- Subjects must have a histological diagnosis of locally advanced or metastatic malignant solid tumors. Subjects must have failed or have been intolerant to established standard therapies, or standard therapies did not exist or were no longer effective for a given tumor type, or in the opinion of the Investigator have been considered ineligible for a particular form of standard therapy on medical grounds.
- Subjects must have at least one evaluable lesion (according to RECIST 1.1, see Appendix 1);
- ECOG Performance Status of 0 or 1.
- Life expectancy ≥ 12 weeks.
- Subjects must have normal levels of total serum calcium and total phosphate.
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- Subjects must have adequate organ and bone marrow function (no hematopoietic growth factor, blood transfusion, or platelet therapy within 1 week before the first dose):
- CBC: neutrophils ≥ 1.5 × 109/L, platelets ≥ 100 × 109/L, hemoglobin ≥ 9.0 g/dL.
- Liver function: total bilirubin ≤ 1.5 × ULN; ALT/AST ≤ 2.5 × ULN without liver metastasis; ALT/AST ≤ 5 × ULN with liver metastasis;
- Coagulation: International normalized ratio (INR) ≤ 1.5 × ULN and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (for patients undergoing anticoagulant therapy. The Investigator will judge that the INR and APTT are within a safe and effective treatment range).
- Renal function: serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 60 mL/min/1.73 m2 in the condition of creatinine level > ULN; urine protein qualitative ≤ 1 + (if ≥ 2+, 24 hours of urine protein test is required, if 24 hours urine protein <1 g, then allowed to enroll);
- Adequate cardiac function left ventricular ejection fraction (LVEF) > 50% for 2 dimensional cardiac ultrasound;
- Subjects must have signed and dated an IRB/IEC approved written informed consent form that under regulatory and institutional guidelines, and this must be obtained before the performance of any protocol-related procedures.
Who cannot join
- Subjects who meet any of the following criteria should be excluded from the study:
- Subjects who received other investigational products or devices in other clinical trials within 4 weeks before the first dose;
- Subjects who received anti-tumor therapy (except for mitomycin, nitrosourea, and fluorouracil oral drugs) within 4 weeks before the first dose, including but not limited to chemotherapy, radiotherapy (palliative radiotherapy is completed at least 2 weeks before the first dose can enroll), targeted therapy or immunotherapy.
- Note: Mitomycin and nitrosourea have been treated within 6 weeks after the last dose; oral fluorouracil such as tegafur and capecitabine has been treated within 2 weeks after the last dose.
- Subjects who previously received FGFR1-3 specific inhibitor therapy.
- Subjects who have previous toxicity of anti-tumor therapy that has not been returned to level 0 or 1. (Alopecia, chemotherapy-induced peripheral neurotoxicity and ototoxicity ≤ Grade 2 can enroll);
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- Subjects who received a CYP3A4 and/or CYP2C8 strong inhibitor or a CYP3A4 strong inducer (see Appendix 6) within 7 days prior to the first dose, and need to continue using these drugs;
- Subjects who have any of the following eye diseases/conditions:
- History of retinal pigment epithelial detachment (RPED);
- History of laser treatment or intraocular injection for macular degeneration;
- History of dry or wet age-related macular degeneration;
- History of retinal vein occlusion (RVO);
- History of retinal degenerative diseases;
- History of chorioretinal lesions;
- Subjects who received clinical intervention for biliary obstruction 14 days prior to the first dose or the Investigator judges that the symptoms had not resolved or required anti-infective treatment.
- Subjects who have gastrointestinal disorders that will affect oral administration or the Investigator judges that the absorption of 3D185 will be interfered.
- Subjects underwent major surgery (except biopsy), or the surgical incision has not completely healed within 4 weeks prior to the first dose.
- Subjects who had clinically uncontrollable pleural effusion, ascites, or pericardial effusion within 2 weeks prior to the first dose.
- Subjects who have symptomatic brain metastases or spinal cord compression. Subjects who have previously treatment for brain metastases, if the clinical condition is stable and imaging evidence does not show disease progression within 4 weeks prior to the first dose, and do not need corticosteroid treatment within 2 weeks prior to the first dose, can enroll.
- Subjects who have active bacterial or fungal infections (CTCAE ≥ 2) that required systemic treatment within 14 days prior to the first dose.
- Subjects who have active HBV infection (Tests should include assessment of HBsAg and HBc IgG antibody. If one parameter is positive, determine HBV-DNA to confirm acute infection. Patients with positive results for HBsAg and/or HBV-DNA are considered active HBV infection) and/or active HCV infection (HCV antibody testing positive);
- Subjects who have clinically significant cardiovascular diseases that occurred 6 months prior to enrollment. Cardiovascular diseases include, but not limited to follows:
- Acute myocardial infarction;
- Severe/unstable angina;
- Cerebrovascular accident or transient ischemic attack;
- Congestive heart failure (New York Heart Association > Class II, see Appendix 3);
- Arrhythmias that require antiarrhythmic treatment except for beta blockers or digoxin;
- Repeated ECG with QTc interval > 450 ms;
- High blood pressure that cannot be controlled by antihypertensive drugs (systolic blood pressure > 150 mm Hg, diastolic blood pressure > 100 mmHg).
- Subjects who have clinically significant abnormal serum electrolytes (Patients must have corrected calcium and phosphate < institutional ULN).
- Subjects who are receiving warfarin (low-dose warfarin as 2 mg/day is acceptable); or receiving antiplatelet anticoagulant therapy (aspirin at dose ≥300 mg/day, clopidogrel at dose ≥75 mg/day).
- Female subjects in pregnancy or lactation. Male subjects or female subjects at reproductive ages who are unwilling to receive effective contraceptive measures.
- Subjects who are judged by the Investigator to be unsuitable for this study
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Sarcoma Oncolog Research Center
Santa Monica, California, 90403
About this study
Official title: A Phase I Study of the Safety, Tolerability, Pharmacokinetics Profiles and Preliminary Efficacy of 3D185 Monotherapy in Subjects With Advanced Solid Tumors
A Phase 1 Study of the Safety, Tolerability, Pharmacokinetics Profiles, and Preliminary Efficacy of 3D185 Monotherapy in Subjects with Advanced Solid Tumors
Read the detailed description
Subjects with advanced solid tumors who have no available standard therapy or who have failed standard therapies.
This is an open-label, global multicenter, dose-escalation phase 1 study of safety, tolerability, preliminary PK profile, and preliminary efficacy of 3D185 capsules monotherapy in subjects with advanced solid tumors.
The starting dose in this dose-escalation study is 50 mg, and the preset 6 dose-escalation cohorts are 50 mg, 100 mg, 150 mg, 200 mg, 250 mg, and 300 mg, respectively.
- Conditions
- Solid Tumor, Adult
- Being tested
- Highly selective FGFR1-3 inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Highly selective FGFR1-3 inhibitorDrug
All subjects in each cohort will receive a single oral dose of 3D185, followed by a 7-day washout period (i.e. single-dose PK study period). Then, subjects will receive consecutive daily doses (Once daily [QD], 28 days/cycle) until disease progression, death, unacceptable toxicity, or withdraw of informed consent, whichever comes first. The dose limiting toxicity (DLT) evaluation period includes the single-dose PK study period and the first treatment cycle (within 35 days after the first dose). The enrolled subjects will be sequentially assigned to the planned dose cohorts according to the protocol and receive 3D185 treatment to observe the occurrence of DLT.
| Study group | Role | What they receive |
|---|---|---|
| Open-Label, Dose-Escalation | Experimental | The starting dose in this dose-escalation study is 50 mg, and the preset 6 dose-escalation cohorts are 50 mg, 100 mg, 150 mg, 200 mg, 250 mg, and 300 mg, respectively. This study adopts an i3+3 method for dose escalation.
All subjects in each cohort will receive a single oral dose of 3D185, followed by a 7-day washout period (i.e. single-dose PK study period). Then, subjects will receive consecutive daily doses (Once daily [QD], 28 days/cycle) until disease progression, death, unacceptable toxicity, or withdraw of informed consent, whichever comes first Receives: Drug: Highly selective FGFR1-3 inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Evaluation: frequency and severity of AEs
Evaluated based on the frequency and severity of AEs according to NCI CTCAE v4.03.
Measured: 24 months
Tolerability Evaluation: frequency and severity of AEs
based on the frequency and severity of AEs according to NCI CTCAE v4.03.
Measured: 24 Months
Secondary outcomes (13)
Efficacy evaluation: Complete Response
Per RECIST version 1.1 criteria in Solid tumors v 1.1 (RECIST) assessed by investigator
Measured: 24 months
Pharmacokinetics (PK) evaluation: Cmax (mg/L)
The test of PK samples will be performed by central laboratory. The PK parameters will be calculated using standard non-compartment models and WinNonlin® Professional 6.4 or higher version (Certara, Princeton, NJ, USA) or SAS® 9.3 or higher version (SAS Institute, Inc., Cary, North Carolina) to fully reflect the drug absorption, distribution and elimination characteristics in the human body. The interim PK parameters will be calculated using the planned blood collection time, and the final PK parameters will be calculated using the actual blood collection time.
Measured: 24 months
PK evaluation: Tmax (minutes)
The test of PK samples will be performed by central laboratory. The PK parameters will be calculated using standard non-compartment models and WinNonlin® Professional 6.4 or higher version (Certara, Princeton, NJ, USA) or SAS® 9.3 or higher version (SAS Institute, Inc., Cary, North Carolina) to fully reflect the drug absorption, distribution and elimination characteristics in the human body. The interim PK parameters will be calculated using the planned blood collection time, and the final PK parameters will be calculated using the actual blood collection time.
Measured: 24 months
PK evaluation: AUC0-24 h, AUC0-96 h, AUC0-∞,
The PK parameters will be calculated using standard non-compartment models and WinNonlin® Professional 6.4 or higher version (Certara, Princeton, NJ, USA) or SAS® 9.3 or higher version (SAS Institute, Inc., Cary, North Carolina) to fully reflect the drug absorption, distribution and elimination characteristics in the human body. The interim PK parameters will be calculated using the planned blood collection time, and the final PK parameters will be calculated using the actual blood collection time.
Measured: 24 months
PK evaluation: t1/2
The test of PK samples will be performed by central laboratory. The PK parameters will be calculated using standard non-compartment models and WinNonlin® Professional 6.4 or higher version (Certara, Princeton, NJ, USA) or SAS® 9.3 or higher version (SAS Institute, Inc., Cary, North Carolina) to fully reflect the drug absorption, distribution and elimination characteristics in the human body. The interim PK parameters will be calculated using the planned blood collection time, and the final PK parameters will be calculated using the actual blood collection time.
Measured: 24 months
PK evaluation: Clearance
The test of PK samples will be performed by central laboratory. The PK parameters will be calculated using standard non-compartment models and WinNonlin® Professional 6.4 or higher version (Certara, Princeton, NJ, USA) or SAS®9.3 or higher version (SAS Institute, Inc., Cary, North Carolina) to fully reflect the drug absorption, distribution and elimination characteristics in the human body. The interim PK parameters will be calculated using the planned blood collection time, and the final PK parameters will be calculated using the actual blood collection time.
Measured: 24 months
PK evaluation: Vd.
The test of PK samples will be performed by central laboratory. The PK parameters will be calculated using standard non-compartment models and WinNonlin® Professional 6.4 or higher version (Certara, Princeton, NJ, USA) or SAS® 9.3 or higher version (SAS Institute, Inc., Cary, North Carolina) to fully reflect the drug absorption, distribution and elimination characteristics in the human body. The interim PK parameters will be calculated using the planned blood collection time, and the final PK parameters will be calculated using the actual blood collection time.
Measured: 24 months
Progressive Disease evaluation
assessed by analyzing the change in serum phosphate levels relative to baseline level over time (Serum biochemistry test).
Measured: 24 months
Efficacy evaluation: Partial Response
Per RECIST version 1.1 criteria in Solid tumors v 1.1 (RECIST) assessed by investigator
Measured: 24 months
Efficacy evaluation: Stable Disease
Per RECIST version 1.1 criteria in Solid tumors v 1.1 (RECIST) assessed by investigator
Measured: 24 months
Efficacy evaluation: Disease Progression
assessed by analyzing the change in serum phosphate levels relative to baseline level over time (Serum biochemistry test).
Measured: 24 months
Objective Response Rale (ORR) (CR+PR)
Per RECIST version 1.1 criteria in Solid tumors v 1.1 (RECIST) assessed by investigator
Measured: 24 months
disease control rate (DCR) (CR+PR+SD)
Per RECIST version 1.1 criteria Per RECIST version 1.1 criteria in Solid tumors v 1.1 (RECIST) assessed by investigator
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2020
- Study start1 Sep 2019
- Primary completion26 Jun 2023
- Study completion26 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies 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
- Not applicable
- Intervention model
- Sequential
- Model description
- sequential assignment The starting dose in this dose-escalation study is 50 mg, and the preset 6 dose-escalation cohorts are 50 mg, 100 mg, 150 mg, 200 mg, 250 mg, and 300 mg, respectively.
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- 3D Medicines (Beijing) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Di Zhu, Study director, 3D Medicines (Beijing) Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04221204
- Sponsor's protocol ID
- 3D185-CN-001
- Status last verified
- Mar 2026
- First submitted
- 13 Dec 2019
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of the Safety, Tolerability, Pharmacokinetics Profiles and Preliminary Efficacy of 3D185 Monotherapy in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04221204
- Acronym / sponsor ID
- 3D185-CN-001
- Conditions
- Solid Tumor, Adult
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- 3D Medicines (Beijing) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 26 Jun 2023 (actual)
- Study completion
- 26 Jun 2023 (actual)
- First posted
- 9 Jan 2020 (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.
A Phase 1 Study of the Safety, Tolerability, Pharmacokinetics Profiles, and Preliminary Efficacy of 3D185 Monotherapy in Subjects with Advanced Solid Tumors
Detailed description
Subjects with advanced solid tumors who have no available standard therapy or who have failed standard therapies.
This is an open-label, global multicenter, dose-escalation phase 1 study of safety, tolerability, preliminary PK profile, and preliminary efficacy of 3D185 capsules monotherapy in subjects with advanced solid tumors.
The starting dose in this dose-escalation study is 50 mg, and the preset 6 dose-escalation cohorts are 50 mg, 100 mg, 150 mg, 200 mg, 250 mg, and 300 mg, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- sequential assignment The starting dose in this dose-escalation study is 50 mg, and the preset 6 dose-escalation cohorts are 50 mg, 100 mg, 150 mg, 200 mg, 250 mg, and 300 mg, respectively.
| Arm | Type | Receives |
|---|---|---|
| Open-Label, Dose-Escalation | Experimental | Drug: Highly selective FGFR1-3 inhibitorThe starting dose in this dose-escalation study is 50 mg, and the preset 6 dose-escalation cohorts are 50 mg, 100 mg, 150 mg, 200 mg, 250 mg, and 300 mg, respectively. This study adopts an i3+3 method for dose escalation. All subjects in each cohort will receive a single oral dose of 3D185, followed by a 7-day washout period (i.e. single-dose PK study period). Then, subjects will receive consecutive daily doses (Once daily [QD], 28 days/cycle) until disease progression, death, unacceptable toxicity, or withdraw of informed consent, whichever comes first |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subjects must be male or female and ≥ 18 years of age on the day of enrollment.
- Subjects must have a histological diagnosis of locally advanced or metastatic malignant solid tumors. Subjects must have failed or have been intolerant to established standard therapies, or standard therapies did not exist or were no longer effective for a given tumor type, or in the opinion of the Investigator have been considered ineligible for a particular form of standard therapy on medical grounds.
- Subjects must have at least one evaluable lesion (according to RECIST 1.1, see Appendix 1);
- ECOG Performance Status of 0 or 1.
- Life expectancy ≥ 12 weeks.
Key exclusion criteria (33 listed)
- Subjects who received other investigational products or devices in other clinical trials within 4 weeks before the first dose;
- Subjects who received anti-tumor therapy (except for mitomycin, nitrosourea, and fluorouracil oral drugs) within 4 weeks before the first dose, including but not limited to chemotherapy, radiotherapy (palliative radiotherapy is completed at least 2 weeks before the first dose can enroll), targeted therapy or immunotherapy.
- Note: Mitomycin and nitrosourea have been treated within 6 weeks after the last dose; oral fluorouracil such as tegafur and capecitabine has been treated within 2 weeks after the last dose.
- Subjects who previously received FGFR1-3 specific inhibitor therapy.
- Subjects who have previous toxicity of anti-tumor therapy that has not been returned to level 0 or 1. (Alopecia, chemotherapy-induced peripheral neurotoxicity and ototoxicity ≤ Grade 2 can enroll);
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 |
|---|---|---|
| Highly selective FGFR1-3 inhibitorAll subjects in each cohort will receive a single oral dose of 3D185, followed by a 7-day washout period (i.e. single-dose PK study period). Then, subjects will receive consecutive daily doses (Once daily [QD], 28 days/cycle) until disease progression, death, unacceptable toxicity, or withdraw of informed consent, whichever comes first. The dose limiting toxicity (DLT) evaluation period includes the single-dose PK study period and the first treatment cycle (within 35 days after the first dose). The enrolled subjects will be sequentially assigned to the planned dose cohorts according to the protocol and receive 3D185 treatment to observe the occurrence of DLT. | Drug | Open-Label, Dose-Escalation |
Primary outcome
Safety Evaluation: frequency and severity of AEs
Time frame: 24 months
Evaluated based on the frequency and severity of AEs according to NCI CTCAE v4.03.
Tolerability Evaluation: frequency and severity of AEs
Time frame: 24 Months
based on the frequency and severity of AEs according to NCI CTCAE v4.03.
13 secondary outcomes
Efficacy evaluation: Complete Response
Time frame: 24 months
Pharmacokinetics (PK) evaluation: Cmax (mg/L)
Time frame: 24 months
PK evaluation: Tmax (minutes)
Time frame: 24 months
PK evaluation: AUC0-24 h, AUC0-96 h, AUC0-∞,
Time frame: 24 months
PK evaluation: t1/2
Time frame: 24 months
PK evaluation: Clearance
Time frame: 24 months
PK evaluation: Vd.
Time frame: 24 months
Progressive Disease evaluation
Time frame: 24 months
Efficacy evaluation: Partial Response
Time frame: 24 months
Efficacy evaluation: Stable Disease
Time frame: 24 months
Efficacy evaluation: Disease Progression
Time frame: 24 months
Objective Response Rale (ORR) (CR+PR)
Time frame: 24 months
disease control rate (DCR) (CR+PR+SD)
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- 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. This study is not recruiting at the moment.
Di Zhu study director
3D Medicines (Beijing) Co., Ltd.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Highly selective FGFR1-3 inhibitor in people with Solid Tumor, Adult, run by 3D Medicines (Beijing) Co., Ltd. at 2 sites in 2 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 13 inclusion and 33 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: finished, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Evaluation: frequency and severity of AEs (time frame: 24 months). The study lists 2 primary outcomes in all. 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 Sep 2026.