STX-0712 for CMML and AML

Overseen By Head of Clinical Operations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Solu Therapeutics, Inc

Must be taking: Hydroxyurea

Must not be taking: Immunosuppressants, Chemotherapy

Disqualifiers: Nicotine use, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 42

105 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called STX-0712 for individuals with advanced blood cancers, specifically CMML (a type of leukemia) and AML (a form of acute leukemia). The main goals are to assess the treatment's safety, its mechanism in the body, and its potential benefits for these challenging conditions. Participants will receive the treatment every 21 days. Those diagnosed with CMML or AML who have not responded to other treatments might be suitable candidates. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you must stop taking your current medications. However, you cannot have received chemotherapy, biologic therapy, or wide-field radiation within 14 days of consent, and certain growth factors within 2 weeks prior to the first dose. Hydroxyurea may be continued up to 72 hours before the first dose and during the first cycle for some participants.

Is there any evidence suggesting that STX-0712 is likely to be safe for humans?

Research shows that STX-0712 is a new treatment under safety testing. It targets a protein called CCR2, found on certain cancer cells in diseases like CMML and AML. Early studies have demonstrated that STX-0712 can effectively kill cancer cells in the lab. However, as this is the first human trial, researchers are still assessing its tolerability and potential side effects.

While earlier lab tests have been promising, the current study phase focuses primarily on understanding its safety in humans. Information on side effects and patient tolerance is still being gathered. The main goal is to ensure STX-0712 is safe before evaluating its effectiveness. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for CMML and AML?

Most treatments for conditions like chronic myelomonocytic leukemia (CMML) and acute myeloid leukemia (AML) revolve around chemotherapy and targeted therapies. However, STX-0712 works differently, offering a novel approach that targets specific pathways involved in these cancers. Researchers are excited about STX-0712 because it has the potential to be more precise in attacking cancer cells, potentially leading to fewer side effects compared to traditional chemotherapy. This precision targeting could result in more effective treatment outcomes for patients struggling with these challenging cancers.

What evidence suggests that STX-0712 might be an effective treatment for CMML and AML?

Research has shown that STX-0712, the investigational treatment in this trial, may help treat CMML and AML, types of advanced blood cancers. In samples from CMML patients, STX-0712 destroyed 66-91% of cancer cells by targeting specific white blood cells involved in the disease. For AML, the drug proved effective in 80% of the samples tested, reducing the number of cancer cells. These findings suggest that STX-0712 could be an effective treatment for these cancers. However, this is based on early research, and further studies are needed to confirm these results. ^{1 2 4 5 6}

Who Is on the Research Team?

Chief Medical Officer, MD, MSc, MBA

Principal Investigator

Solu Therapeutics

Are You a Good Fit for This Trial?

This trial is for patients with advanced blood cancers, specifically CMML and AML, who have no other treatment options known to be effective. The exact eligibility criteria are not provided, but typically include factors like age, health status, and previous treatments.

Inclusion Criteria

Life expectancy of >2 months and stable enough to complete two cycles of STX-0712, in the opinion of the Investigator

Both females of child-bearing potential and males must agree to use acceptable contraceptive methods for the duration of time in the study and to continue to use acceptable contraceptive methods for 90 days after last STX-0712 infusion

Able to understand and willing to sign a written informed consent form

Exclusion Criteria

Received an investigational treatment within 30 days prior to dosing with STX-0712

Current active use of nicotine products including tobacco, nicotine patches or vaping products

Evidence of any other severe or uncontrolled systemic diseases, any other serious and/or unstable pre-existing medical conditions, psychiatric disorder, or other conditions that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the Investigator

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive STX-0712 every 21 days to determine the maximum tolerated dose and/or minimum effective dose

12 months

Every 21 days

Dose Expansion

Participants receive STX-0712 every 21 days to evaluate safety, PK, PD, and preliminary efficacy

12 months

Every 21 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• STX-0712

Trial Overview The study tests STX-0712's safety and effectiveness in treating certain blood cancers. It's a first-in-human trial meaning this drug hasn't been tested in people before. Patients will receive STX-0712 to see how their bodies react (PK/PD) and if it helps their condition.

How Is the Trial Designed?

Group I: Dose Expansion in CMML Experimental Treatment 1 Intervention

STX-0712 will be administered every 21 days.

Group II: Dose Expansion in AML Experimental Treatment 1 Intervention

STX-0712 will be administered every 21 days.

Group III: Dose Escalation in CMML Patients Experimental Treatment 1 Intervention

STX-0712 will be administered every 21 days.

Group IV: Dose Escalation in AML Patients Experimental Treatment 1 Intervention

STX-0712 will be administered every 21 days.

Who Is Running the Clinical Trial?

Solu Therapeutics, Inc

Lead Sponsor

Published Research Related to This Trial

In a study comparing leukaemic cells from six chronic myeloid leukaemia (CML) patients during chronic phase and blast crisis, the cells showed similar sensitivity to the drug STI571, indicating that intrinsic resistance is not a major factor in blast crisis.

Despite the similar sensitivity to STI571, patients in blast crisis generally experience only transient responses to the treatment, suggesting that other factors beyond drug sensitivity may contribute to treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sensitivity to the abl inhibitor STI571 in fresh leukaemic cells obtained from chronic myelogenous leukaemia patients in different stages of disease. Gambacorti-Passerini, C., Barni, R., Marchesi, E., et al.[2019]

Since 2017, the FDA has approved nine new agents for treating acute myeloid leukemia (AML), marking significant progress in AML therapy after decades of slow advancement.

Specific treatments for subsets of AML, such as all-trans retinoic acid and arsenic trioxide for acute promyelocytic leukemia, have led to impressive 10-year survival rates of over 80%, demonstrating the efficacy of targeted therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute myeloid leukemia: Treatment and research outlook for 2021 and the MD Anderson approach. Kantarjian, HM., Kadia, TM., DiNardo, CD., et al.[2021]

In a phase I trial involving 20 patients with acute myeloid leukemia (AML), the combination of selinexor with high-dose cytarabine and mitoxantrone was found to be feasible and tolerable, with no dose-limiting toxicities observed at the target dose of 80 mg.

The treatment resulted in a 70% overall response rate, with 50% of patients achieving complete remission, indicating promising efficacy for selinexor in combination therapy for AML.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase I study of selinexor in combination with high-dose cytarabine and mitoxantrone for remission induction in patients with acute myeloid leukemia. Wang, AY., Weiner, H., Green, M., et al.[2022]

Vaccination with autologous dendritic cells (DCs) derived from leukemic blasts in five AML patients was well tolerated, with no severe adverse effects reported, and resulted in stable conditions for three patients lasting 5.5 to 13 months.

The vaccination led to a significant increase in CD8+ T cells that specifically recognized a leukemia-associated antigen, indicating an enhanced immune response against AML, as evidenced by increased granzyme B release and a shift towards a type 1 T helper cell cytokine pattern.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunotherapy for patients with acute myeloid leukemia using autologous dendritic cells generated from leukemic blasts. Li, L., Giannopoulos, K., Reinhardt, P., et al.[2023]

In a study of 79 patients treated with CPX-351 for acute myeloid leukemia (AML), the treatment achieved a complete remission rate of 52% and a 60-day mortality rate of 18%, indicating its potential effectiveness in this patient population.

When compared to a matched cohort receiving standard intensive chemotherapy, CPX-351 showed similar rates of complete remission and overall survival, but a higher percentage of patients were able to undergo stem cell transplant, suggesting a possible advantage in treatment pathways.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes after CPX-351 in patients with high-risk acute myeloid leukemia: A comparison with a matched cohort from the Spanish PETHEMA registry. Bernal, T., Moreno, AF., de LaIglesia, A., et al.[2023]

Citations

1. ashpublications.org ashpublications.org/blood/article/144/Supplement%201/1380/531323/Ex-Vivo-Evaluation-of-Stx-0712-a-CCR2-Cytotoxicity

Ex-Vivo Evaluation of Stx-0712, a CCR2 Cytotoxicity Targeting ... The results showed a robust activity of STX-0712 in the CD11b+ malignant population in 12 of the 15 (80%) patients evaluated with an average ...

2. prnewswire.com prnewswire.com/news-releases/solu-therapeutics-presents-positive-preclinical-data-on-stx-0712-for-chronic-myelomonocytic-leukemia-and-acute-myeloid-leukemia-at-ash-annual-meeting-302325514.html

Solu Therapeutics Presents Positive Preclinical Data on ... In all patient samples tested, STX-0712 effectively depleted CD14+CCR2+ monocytes, achieving 66–91% cancer cell elimination with an average ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006497124041272

Ex-Vivo Evaluation of Stx-0712, a CCR2 Cytotoxicity ... The percentage of CCR2 positive tumor cells in AML samples ranged from 2.4% to 97.1% across different AML subtypes with primitive forms of AML ( ...

4. withpower.com withpower.com/trial/phase-1-leukemia-2-2025-88a6b

STX-0712 for CMML and AML What data supports the effectiveness of the treatment STX-0712 for CMML and AML? The research highlights the potential of immune-based therapies, like those ...

5. synapse.patsnap.com synapse.patsnap.com/blog/solu-therapeutics-shares-promising-preclinical-results-for-stx-0712-in-leukemia-at-ash

Solu Therapeutics Shares Promising Preclinical Results for ... In all patient samples examined, STX-0712 efficiently depleted CD14+CCR2+ monocytes, achieving 66–91% cancer cell elimination with an average ...

6. ctv.veeva.com ctv.veeva.com/study/a-phase-1-study-of-stx-0712-in-patients-with-advanced-hematological-malignancies-cmml-and-aml

A Phase 1 Study of STX-0712 in Patients With Advanced ... This is a first-in-human, multicenter, open-label, phase 1 study to evaluate the safety, PK, PD and preliminary efficacy of STX-0712 in ...