New combo therapy targets tough blood cancers in early trial
NCT ID NCT05428969
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 181 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2022
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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City of Hope National Medical Center
Duarte, California, 91010, United States
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Helsinki University Hospital
Helsinki, 00029, Finland
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Kuopio University Hospital
Kuopio, 70210, Finland
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Oulu University Hospital
Oulu, 90029, Finland
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Royal Cornwall Hospitals NHS Trust
Truro, United Kingdom
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Tampere University Hospital
Tampere, 33520, Finland
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The Christie NHS Foundation Trust
Manchester, United Kingdom
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UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
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University of Texas, MD Anderson Cancer Center
Houston, Texas, 77030, United States
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Yale Cancer Center
New Haven, Connecticut, 06510, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can an HDAC inhibitor wipe out residual leukemia cells?
- Can an experimental pill block a cancer-driving enzyme in hard-to-treat leukemia?
- Two-Drug combo targets leukemia that outsmarted its first treatment
- Tweaking donor cells may shield older transplant patients from a dangerous complication
- Can a drug and donor cells stop leukemia from returning after transplant?