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Iteria Biopharma has registered a first-in-human Phase I/Ib study of its investigational MAO-A inhibitor ITR-251 in advanced solid tumors. The Spain-based company expects the trial to start in the fourth quarter of 2026, but the study is not yet recruiting and ITR-251 is neither approved nor available as a cancer treatment.
What Iteria registered
AllSci reported on 14 October 2026 that Iteria Biopharma, S.L., registered the study under the acronym STRIVE-251 and protocol ITR-251CT-01. The current 2026 registry mirror identifies it as NCT07870096, a Phase 1 study sponsored by Iteria in Spain. Its status is “not yet recruiting,” with a target enrollment of up to 46 participants. The listed start timing is an estimate for the fourth quarter of 2026 and can change as regulatory, site and operational preparations proceed.
This is a dose-finding, first-in-human study, not a test designed to establish that ITR-251 extends survival or controls cancer. The principal early questions are whether people can receive the drug safely, how the body absorbs and clears it, what dose should move into later development, and whether any preliminary antitumor signal justifies further study.
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How the STRIVE-251 trial is designed
| Element | Planned approach |
|---|---|
| Study phase | Phase I/Ib, first human exposure |
| Design | Open-label and sequential |
| Initial population | Adults with advanced solid tumors that have progressed after standard treatments |
| Initial treatment | ITR-251 alone during dose escalation |
| Later population | Metastatic castration-resistant prostate cancer (mCRPC) |
| Combination in expansion | ITR-251 with an androgen-receptor pathway inhibitor and androgen-deprivation therapy |
| Overall target enrollment | Up to 46 participants, according to the 2026 registry mirror |
| mCRPC expansion | Up to 20 evaluable patients, according to the 2026 TrialTicker registry summary |
Stage one: dose escalation
The opening part gives single-agent ITR-251 to patients with advanced solid tumors after standard options have stopped controlling the disease. Investigators increase doses in sequential groups while monitoring adverse events, laboratory results, pharmacokinetics and other safety measures. The goal is to identify a tolerable dose range and select a recommended Phase II dose, rather than to compare ITR-251 with an established therapy.
Stage two: prostate-cancer expansion
After a recommended dose is selected, the protocol plans an expansion in mCRPC. Participants will receive ITR-251 on top of hormonal treatment built around androgen-receptor pathway inhibition and androgen-deprivation therapy. The registry summary lists safety, tolerability, pharmacokinetics, dose selection and preliminary antitumor activity among the objectives. “Preliminary activity” can include signals such as changes in prostate-specific antigen or imaging findings, but results from this study would remain exploratory without a controlled comparison and longer follow-up.
Why Iteria is targeting MAO-A
Monoamine oxidase A (MAO-A) is an enzyme best known for its role in neurotransmitter metabolism, but laboratory research has also connected it with prostate-cancer biology. The rationale for ITR-251 is that MAO-A activity may interact with androgen-receptor signaling, a central driver of prostate cancer and a major target of hormonal therapies.
A Nature Communications study cited in the company’s scientific rationale reported that the MAO-A inhibitors phenelzine and clorgyline restored sensitivity to enzalutamide in resistant prostate-cancer models, including cell and animal experiments. Separate Cancer Research work described a mutually reinforcing relationship between MAO-A and androgen-receptor activity and found greater growth inhibition when MAO-A targeting was combined with androgen-receptor inhibitors in cancer cells.
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Those findings explain the combination strategy in mCRPC, but they are preclinical. They do not show that ITR-251 reaches the same targets in patients, reverses hormone resistance in people, shrinks tumors or improves survival.
What is intended to distinguish ITR-251
Spanish research-funding information summarized by AllSci describes Iteria’s ONCOMAO project as developing selective, noncovalent MAO-A inhibitors designed to have limited penetration into the brain. ITR-251 is described in those terms. Selectivity and reduced brain exposure are development goals that could, if demonstrated clinically, affect tolerability and dosing; neither a better therapeutic window nor clinical efficacy has been established.
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The trial will provide the first human pharmacokinetic and safety information needed to test whether that intended profile is achieved. Until those data are reported, comparisons with older MAO-A drugs remain theoretical rather than evidence of superiority.
What earlier phenelzine experience can—and cannot—tell us
A small Phase II study of phenelzine in prostate cancer reported prostate-specific-antigen reductions in some participants but also cardiovascular toxicities. Phenelzine is not ITR-251, and that study was not a test of Iteria’s compound. Its relevance is historical: it shows why cardiovascular monitoring, dose selection and a careful assessment of central-nervous-system and other systemic effects are important when developing another MAO-A inhibitor.
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Phenelzine and clorgyline should therefore be treated as scientific comparators used to frame the biology, not as recommendations or substitutes for an approved prostate-cancer treatment.
Is ITR-251 approved or available?
- Approval: ITR-251 is investigational and has no reported marketing approval for cancer.
- Availability: It is not a medicine that patients can obtain by prescription or purchase. Access, if the study opens, would be through the clinical-trial process.
- Evidence: Publicly described support currently consists of preclinical MAO-A and androgen-receptor findings; no human efficacy data have been reported.
- Recruitment: NCT07870096 is listed as not yet recruiting. The estimated fourth-quarter 2026 start is not a guarantee of enrollment on that date.
People with advanced cancer should not delay or replace proven care while waiting for this program. Potential participants would need to meet the final protocol’s disease, prior-treatment, organ-function and other eligibility requirements at an activated Spanish study site.
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What to watch when the study opens
- Whether the first participants can receive planned doses without dose-limiting or unexpected toxicity.
- The pharmacokinetic exposure and whether it supports the intended limited brain-penetration profile.
- The recommended Phase II dose and the rules used to move from escalation into the mCRPC expansion.
- How many patients actually enter each tumor group, since a small, mixed solid-tumor cohort limits interpretation.
- Any prostate-specific-antigen, imaging or duration-of-response signals, interpreted as exploratory until tested in larger controlled studies.
Funding and development context
AllSci reported that Iteria raised EUR 5 million in seed financing from Inveready, Xesgalicia and founding partners to support ITR-251’s preclinical work and first clinical trial. That financing indicates resources allocated to the program, not evidence that the drug works or that later-stage trials are guaranteed.
Bottom line for readers
ITR-251 is entering the earliest clinical stage of development. The scientifically important test is whether a selective, intended-to-be brain-sparing MAO-A inhibitor can be dosed safely in people and then combined with hormonal therapy in mCRPC. The registry currently shows a Spanish, not-yet-recruiting Phase I/Ib study; any claim of effectiveness, approval or patient access would be premature until clinical results are available.
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