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Solid Tumor CancerPhase 1STRIVE-251NCT07870096

ITR-251 in Patients With Advanced Solid Tumors

A Phase 1 study testing ITR-251, ITR-251 at RP2D and ARPI therapy in people with Solid Tumor Cancer and Castration Resistant Metastatic Prostate Cancer, run by ITERIA BIOPHARMA, S.L. at 1 site in Spain.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This is an open-label, Phase I/Ib trial including an initial dose-escalation phase in patients with advanced solid tumors and a dose-expansion phase at recommended phase 2 dose (RP2D) in combination with Androgen Receptor Pathway Inhibitors (ARPi) in patients with metastatic castration resistant prostate cancer… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ITR-251, ITR-251 at RP2D and ARPI therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteSpain
Study dates
Oct 2026to Jul 2029
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

  • Patients must be fully informed about the study and sign the informed consent form (ICF) before any study specific assessment.
  • Patients ≥18 years old at the time of signing the informed consent.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 prior to study entry.
  • Have measurable disease per RECIST v1.1 or PCWG4 criteria (for mCRPC).
  • Adequate organ and bone marrow function as follows (subject must not have received any growth factor within 4 weeks or a blood transfusion within 7 days of the hematology laboratory):
  • Absolute neutrophil count (ANC) ≥ 1.5 x109/L;
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  • Platelets ≥ 100 x109/L;
  • Hemoglobin ≥ 9.0 g/dl;
  • Prothrombin time (PT) or international normalised ratio (INR) ≤1.5 × ULN;
  • Total bilirubin level ≤ 1.5 x institutional upper limit of normal (ULN), except for patients with Gilbert's disease ≤ 5.0 x ULN;
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN;
  • Creatinine ≤ 1.5 x ULN;
  • creatinine clearance (CrCl) ≥ 30 mL/min;
  • Albumin > 25 g/L.
  • Criteria Specific for Dose-escalation phase:
  • Patients with any histologically or cytologically confirmed solid tumor at advanced or metastatic stage.
  • Note: glioblastoma, cholangiocarcinoma, gastric, liver, or nasopharyngeal carcinomas are excluded given the potential negative impact of MAO-A inhibition and effect in reactive oxygen species (ROS) metabolism in these tumor types.
  • Disease progression to standard of care therapies within one month prior to study entry.
  • Note: Patients should have no available standard of care therapy likely to confer clinical benefit in the opinion of the investigator.
  • Life expectancy > 6 months.
  • Criteria Specific for Dose-expansion phase:
  • Patients with histologically or cytologically confirmed mCRPC receiving ARPi treatment (including: abiraterone, apalutamide, enzalutamide or darolutamide) and experiencing PSA progression (any increase above 0.2 ng/mL in PSA level from baseline/nadir, confirmed by one additional rising PSA measurement at least 21 days apart) confirmed.
  • Note: the inclusion of patients will be limited to 50% with abiraterone and 50% with androgen receptor targeted agents (ARTAs).
  • Note: Patients should have castration resistant prostate cancer (CRPC) as defined by PCWG4 criteria.
  • Note: patients with prior therapies for locoregional disease and/or initiating ARPis in the hormone-sensitive that progressed to CRPC setting are eligible.
  • Note: Patients candidates for concurrent treatment with androgen deprivation therapy (ADT) according to the standard clinical practice are allowed.
  • Patients with a Charlson score ≤ 3 prior to study entry.
  • Contraceptive and other requirements:
  • Participants who have pregnant partners must use a condom and those with partners of childbearing potential must use a condom and another adequate birth control measure if engaging in sexual activities during the study treatment period and for at least 4 weeks after the last dose of ITR-251. A highly effective method of birth control is defined as those which result in low failure rate (i.e., less than 1% per year) when used consistently and correctly.
  • During the dose-escalation phase, women of childbearing potential (WOCBP) and their partners must agree to use a highly effective method of birth control during the study treatment period and for at least 4 weeks after the last dose of ITR-251.
  • Are willing and able to comply with scheduled visits, treatment schedule, the planned trial assessments, lifestyle restrictions, and other requirements of the trial. This includes that they are able to understand and follow trial-related instructions.

Who cannot join

  • For Dose-escalation phase only: women pregnant or breastfeeding.
  • For Dose-escalation phase only: Patients with glioblastoma, cholangiocarcinoma, gastric, liver, or nasopharyngeal carcinomas.
  • For dose-expansion phase only: patients with symptomatic or radiologic PD requiring or tributary for treatment with docetaxel or other concurrent anticancer therapies other than ADT and ARPi.
  • Patients with brain metastasis.
  • Required concurrent treatment with other investigational medicinal products or participation in other clinical trials.
  • Previous treatment with MAO-A inhibitors.
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  • Treatment with antidepressant or psychostimulants, opioids or analgesics, antitussives and antihistaminics listed as prohibited concomitant medication within one month or 5 halflives, whichever is longer, prior to the study entry or patients with foreseen potential requirement of antidepressants during the study.
  • Previous systemic anticancer treatments should have been discontinued 15 days prior to study entry.
  • Note for dose-expansion phase: Continuous treatment with ADT and ARPi before start of study treatment is allowed.
  • Residual toxicity from prior anticancer therapy that are NCI-CTCAE v6.0 Grade ≥ 2, except for Grade ≥ 2 alopecia.
  • Note: Stable chronic Grade 2 toxicities from previous treatments may be eligible per the judgement of the investigator.
  • Have had major surgery (not including diagnostic surgery) within the 4 weeks prior to the first dose of trial treatment or are planned to undergo major surgery during the course of the trial.
  • Known secondary active malignancy requiring treatment within the last 2 years prior to study entry.
  • Note: Patients that have secondary malignancies that have undergone potentially curative therapy are eligible.
  • Body mass index (BMI) < 15 kg/m2 or patients with symptomatic malnutrition (GLIM criteria).
  • Uncontrolled hypertension despite appropriate medical therapy (blood pressure [BP] > 160 mmHg systolic and 90 mmHg diastolic at 2 separate measurements no more than 60 minutes apart during the screening visit).
  • Note: patients may be rescreened after adjustment of antihypertensive medications.
  • History of hypertensive crisis.
  • Known prior history of mania or major psychiatric illness (schizophrenia, bipolar disorder, severe major depression requiring hospitalization, psychosis, etc.).
  • Patients with a pre-existing diagnosis of severe insomnia (Grade 3 according to CTCAE v6.0) or primary sleep disorders (e.g., severe obstructive sleep apnea, narcolepsy) who have required adjustments to their pharmacological treatment in the 28 days prior to inclusion.
  • Patients at high risk (i.e. categories 4, 5, or any suicide behaviors [6-9]) of suicide according to the validated Columbia Scale (C-SSRS).
  • Patients with ongoing or active severe infections requiring treatment.
  • Patients with symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia.
  • History of stroke or significant cerebrovascular disease (ie, transient ischemic attack) within 6 months prior to initiation of study intervention.
  • History of clinically significant cardiac disease within 6 months prior to the initiation of study intervention, including but not limited to unstable angina, acute myocardial infarction, endoscopic or open-heart cardiac surgery, or heart failure classified as New York Heart Association Grade ≥ 2, left ventricular ejection fraction <45% or interval corrected by Fridericia (QTcF) >470 ms (for women) and >450 ms (for men) or clinically significant arrhythmias.
  • History of clinically significant respiratory disease within 6 months prior to the initiation of study intervention, including severe chronic obstructive pulmonary disease or asthma.
  • History of noninfectious interstitial lung disease (ILD) /pneumonitis /radiation pneumonitis that required steroids or has current ILD/pneumonitis.
  • Clinically significant gastrointestinal disorder including bleeding, occlusion, diarrhoea >Grade 1, malabsorption syndrome, ulcerative colitis, inflammatory bowel disease or partial bowel obstruction.
  • Any intercurrent gastrointestinal condition that may affect the ingestion and absorption of ITR-251.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to ITR-251 or other monoamine oxidase inhibitors.
  • History or current drug abuse.
  • Uncontrolled intercurrent illness, or condition or psychiatric illness/social situations that would limit compliance with study requirements.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

MFAR Clinical Research contact

0034934344412

investigacio@mfar.net

Cristina López Sanjurjo contact

clopez@iteriabiopharma.com

Spain1 site

  • Institut Català d'Oncologia (ICO)

    L'Hospitalet de Llobregat, Barcelona, 08908

    A responsible person Designated by the Sponsor, 0034934344412, investigacion@mfar.net

    A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.

Other trials in Spain

About this study

Official title: Phase I/Ib Trial of Single Agent ITR-251 in Patients With Advanced Solid Tumors With an Expansion-Phase in Metastatic Castration-Resistant Prostate Cancer

This is an open-label, Phase I/Ib trial including an initial dose-escalation phase in patients with advanced solid tumors and a dose-expansion phase at recommended phase 2 dose (RP2D) in combination with Androgen Receptor Pathway Inhibitors (ARPi) in patients with metastatic castration resistant prostate cancer (mCRPC).

The trial will enroll following a 3+3 design up to 6 patients with any type of solid tumors after progression to standard treatments at each dose level during the dose-escalation phase. Four dose levels are planned. If the first DL is deemed not safe, the next patients could be treated at a lower dose. If further reductions are required, the study will be stopped. After determining the RP2D, the trial will enroll up to 20 additional evaluable patients with mCRPC during the dose-expansion phase. The first six patients enrolled in the dose-expansion phase will be the safety lead in cohort for the combination and will be monitored for DLTs. The rest of patients will be enrolled afterwards at the RP2D if found safe or with a lower ITR-251 dose level if the combination shows unacceptable toxicity.

The study aims to determine the RP2D of ITR-251 and the safety in combination with ARPi in mCRPC. Secondary objectives includes duration of treatment, tolerability, pharmacokinetics, and preliminary signs of antitumoral activity and efficacy. Pharmacodynamics will be an exploratory objective.

Being tested
ITR-251, ITR-251 at RP2D, ARPI therapy, Androgen Deprivation Therapy (ADT)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ITR-251Drug

    ITR-251 is a potent and selective inhibitor of Monoamine Oxidase A (MAO-A) with reversible inhibition and limited capacity for blood brain barrier (BBB) crossing.

    Four dose levels will be tested. Dose could be also reduced to dose level -1.

  • ITR-251 at RP2DDrug

    ITR-251 is a potent and selective inhibitor of MAO-A with reversible inhibition and limited capacity for blood brain barrier (BBB) crossing.

    Dose at RP2D

  • ARPI therapyDrug

    ARPIs are blockers of the androgen receptor pathway, which play a pivotal role in treating prostate cancer, showing significant efficacy across different disease stages. ARPi will be given according to standard clinical practice

  • Androgen Deprivation Therapy (ADT)Drug

    ADTs reduce availability of male hormones (androgens like testosterone) that fuel cancer growth and it is the backbone for many standard treatment combinations in prostate cancer, including in the castration resistant setting in combination with ARPis. ADT will be given according to standard clinical practice.

Study groups in NCT07870096
Study groupRoleWhat they receive
Dose-EscalationExperimentalDose-Escalation will establish a recommended Phase 2 dose (RP2D) of ITR-251
Receives: Drug: ITR-251
Dose-ExpansionExperimentalOn completion of dose-escalation, dose-expansion will determine safety and preliminary efficacy of ITR-251 at RP2D in combination with ARPIs for mCRPC
Receives: Drug: ITR-251 at RP2D; Drug: ARPI therapy; Drug: Androgen Deprivation Therapy (ADT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. RP2D of ITR-251

    During dose-escalation phase, patients will be included sequentially into cohorts with escalating dose levels. RP2D is defined as the highest dose level at which <33% of patients reported a dose limiting toxicities (DLT) (i.e. ≤ 1 DLT out of 6 patients) providing the safety profile is amenable.

    DLT is defined as any of the following events during the DLT reporting period:

    1. Hematologic toxicities:
    2. Grade (G) 3 febrile neutropenia lasting > 7 days
    3. G4 thrombocytopenia lasting > 7 days
    4. G3 thrombocytopenia with clinically significant bleeding
    5. Gr ≥3 anemia requiring urgent transfusion support
    6. Non-hematologic toxicities:
    7. Any G ≥3 non-hematologic toxicity, excluding non relevant nausea, vomiting, or diarrhea, laboratory abnormalities or cutaneous events.
    8. Hypertensive crisis
    9. Severe serotonin syndrome
    10. G ≥3 arrhythmia
    11. QTcF prolongation >500 ms or increase >60 ms from baseline
    12. Received < 75% of the intended ITR-251 dose during the DLT period due to toxicity

    Measured: DLT period is 28 days since first dose of study treatment

  2. Treatment-emergent adverse events

    incidence of treatment-emergent adverse events (TEAEs) classified by grade and seriousness

    Measured: Throughout the study period, approximately 12 months

Secondary outcomes (13)

  1. Duration of treatment

    Defined as the time from the first dose of ITR-251 to the permanent discontinuation of ITR-251 treatment for any reason. Patients with treatment ongoing will have their last administration date as the last date on treatment for timing calculation.

    Measured: Throughout the study period, approximately 12 months

  2. Incidence of treatment modifications

    number of patients requiring treatment dose reduction, interruptions and permanent discontinuations for management of TEAEs

    Measured: Throughout the study period, approximately 12 months

  3. Pharmacokinetic (PK) profile

    Cmax and Tmax of ITR-251 will be reported. The study will include analysis of patients in fasted and fed conditions

    Measured: Within the first months of treatment with ITR-251

  4. Objective response rate (ORR)

    Proportion of patient who achieved a complete response (CR) or partial response (PR) according to prostate cancer working group (PCWG4) (in case of prostate cancer) or RECIST V1.1 (all other tumors). ORR will be assessed by investigators using computed tomography (CT) or magnetic resonance imaging (MRI) scans.

    Measured: Throughout the study period, approximately 12 months

  5. Time to progression (TTP)

    Only for dose-escalation phase. Defined as the time elapsed from first dose of ITR-251 treatment until the date of disease progression assessed by the local investigators according to RECIST V1.1 criteria

    Measured: Throughout the study period, approximately 12 months

  6. Radiological progression-free survival (rPFS)

    Only dose-expansion phase. Assessed by investigator according to PCWG4 Criteria and defined from the day of first dose of ITR-251 to the day the first event of radiological progression or death (due to any cause) is recorded. rPFS will be estimated by Kaplan-Meier method. Patients who are alive without evidence of radiological progression at their last imaging assessment will be censored at that date.

    Measured: Throughout the study period, approximately 12 months

  7. Prostate specific antigen (PSA) response rates

    Only dose-expansion phase. defined as blood PSA <0.02 ng/mL confirmed with a subsequent PSA value <0.02 ng/mL 3 or more weeks later. Rate of absolute PSA response is defined as the number of subjects with absolute PSA response, divided by the total number of subjects evaluable for absolute PSA response (with high PSA levels at baseline).

    Measured: Throughout the study period, approximately 12 months

  8. Time to PSA progression

    Only dose-expansion phase. Defined as the time elapsed from first dose of ITR-251 treatment until the date of any increase in PSA level from baseline/nadir, confirmed by one additional rising PSA measurement and with a minimum absolute increase of 0.2 ng/mL.

    Measured: Throughout the study period, approximately 12 months

  9. Duration of Response (DoR)

    Only dose-expansion phase. Time from first response (CR or PR), according to ORR definition for the trial, to the date of the documented disease progression (PD) as determined using RECIST 1.1 / PCWG4 criteria (patients with mCRPC) or death due to any cause, whichever occurs first. Those patients with response and without PD or death event will be censored on the date of their last tumor assessment.

    Measured: Throughout the study period, approximately 12 months

  10. Disease control rate (DCR)

    Only dose-expansion phase. Defined as the proportion of patients who had CR, PR, or a stable disease (SD) maintained at least for 3 months as their best response throughout the study period, defined as PCWG4 criteria.

    Measured: Throughout the study period, approximately 12 months

  11. Time to pain progression (TTPP)

    Only dose-expansion phase.

    Time-to-pain progression is defined as the time (days) from the first dose of study treatment (ITR-251) date, to the date of pain progression measured according to Brief Pain Inventory (BPI). Pain progression is defined in patients in the 'pain evaluable' population as:

    an increase of 2 or more points in the BPI's "worst pain in 24 hours"-score from baseline observed at 2 consecutive evaluations ≥4 weeks apart, or initiation of short or long-acting opioid use for pain.

    Measured: Throughout the study period, approximately 12 months

  12. Time to next treatment (TTNT)

    Only dose-expansion phase. This is the interval of time between first dose of study treatment and the first day of initiation of a next line of systemic antineoplastic therapy after the initial scheduled treatment.

    Measured: Throughout the study period, approximately 12 months

  13. Overall survival (OS)

    Only dose-expansion phase. OS will be measured from the date of first dose of study treatment (ITR-251) to the date of death whatever the cause of death. OS will be estimated by Kaplan-Meier method. Patients who are alive are censored at the date of the most recent follow-up examination.

    Measured: Throughout the study period, approximately 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionJul 2029 (estimated)
  4. Study completionJul 2029 (estimated)

Resources

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
First-in-human, open label, Phase I/Ib Clinical Trial
Masking
None (open label)
Enrolment
46 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07870096
Sponsor's protocol ID
ITR-251CT-01
Other IDs
2026-527383-32-00
Acronym
STRIVE-251
Status last verified
Oct 2026
First submitted
6 Oct 2026
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ITR-251, ITR-251 at RP2D and ARPI therapy in people with Solid Tumor Cancer and Castration Resistant Metastatic Prostate Cancer, run by ITERIA BIOPHARMA, S.L. at 1 site in Spain.

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 31 inclusion and 32 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 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. 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 MFAR Clinical Research (0034934344412, investigacio@mfar.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

RP2D of ITR-251 (time frame: DLT period is 28 days since first dose of study treatment). 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?

On the ClinicalTrials.gov record for NCT07870096.

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 13 Oct 2026; AzTrials last refreshed its copy on 27 Oct 2026.

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