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New combo therapy targets tough blood cancers in early trial

NCT ID NCT05428969

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug called bexmarilimab, given together with standard treatments, for people with certain blood cancers (MDS, CMML, or AML). The goal is to first find a safe dose and then see if the combination helps shrink or control the cancer. About 181 adults are taking part in this early-phase trial.

Why investors are watching

Faron Pharmaceuticals is testing its drug bexmarilimab, which targets a protein called Clever-1, in patients with three blood cancers: myelodysplastic syndrome, chronic myelomonocytic leukemia, and acute myeloid leukemia. The trial combines the drug with standard care and first finds a safe dose, then checks if it works. For a micro-cap company with few products, this readout could shape its entire value.

If it works: If the drug shows a tolerable safety profile and signs of disease control, Faron could have a viable candidate for a group of patients with limited options. That result might support further development and partnerships.

If it fails: The trial could fail to show benefit or produce safety problems, which would set the program back. Most experimental cancer drugs do not succeed, and a negative result would leave Faron with fewer prospects.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 181 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2022

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patient ≥ 18 years of age who presents with one of the following conditions: * Morphologically confirmed diagnosis of MDS with revised International Prognostic Scoring System (rIPSS) risk categories: intermediate, high and very high. * Morphologically confirmed diagnosis of CMML-2 with indication for azacitidine treatment. * CMML and MDS patient with response failure to HMA or therapy regimen including HMA. * Morphologically confirmed diagnosis of r/r AML following at least 1 line of prior therapies with indication for azacitidine treatment. * Morphologically confirmed diagnosis of AML in patients unfit for induction therapy with indication for azacitidine-venetoclax treatment. * Leukocyte count \< 20 x10\^9/L (\< 25 x10\^9/L for newly diagnosed AML). Hydroxycarbamide use is permitted to meet this criterion in MDS and AML but not in CMML. * Adequate renal function. * Adequate liver function. Exclusion Criteria: * Patient with acute promyelocytic leukemia (APL) or myeloproliferative CMML as defined by leukocyte count \> 13 x10\^9/L. * Eastern Cooperative Oncology Group (ECOG) performance status \>2 (except newly diagnosed AML where ECOG 3 is allowed for patients \< 75 years). * Allogeneic transplantation less than 6 months prior screening. * Patient with active auto-immune disorder (except type I diabetes, celiac disease, hypothyroidism requiring only hormone replacement, vitiligo, psoriasis, or alopecia). * The patient requires systemic corticosteroid (≥10 mg/day prednisone or equivalent) or other immunosuppressive treatment. * Less than 21 days since the last dose of intravenous anticancer chemotherapy or less than 14 days or five half-lives (whichever is shorter) from a small molecule targeted therapy or oral anticancer chemotherapy before the first study treatment. * Any immunotherapy or investigational therapy within preceding 28 days from the first study treatment. * Pregnant or lactating women. * History of chronic ulcers or clinically relevant liver disease leading to Child Pugh Score C or higher.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • City of Hope National Medical Center

    Duarte, California, 91010, United States

  • Helsinki University Hospital

    Helsinki, 00029, Finland

  • Kuopio University Hospital

    Kuopio, 70210, Finland

  • Oulu University Hospital

    Oulu, 90029, Finland

  • Royal Cornwall Hospitals NHS Trust

    Truro, United Kingdom

  • Tampere University Hospital

    Tampere, 33520, Finland

  • The Christie NHS Foundation Trust

    Manchester, United Kingdom

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599, United States

  • University of Texas, MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Yale Cancer Center

    New Haven, Connecticut, 06510, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.