Oral AMXT 1501 Dicaprate in Combination With IV DFMO

Study summary

A Phase 1B/2A study will be conducted to establish safety and dose level of AMXT 1501 dicaprate in combination with IV DFMO, in cancer patients.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedAMXT1501 and DFMO

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Mesothelioma

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Dec 24, 2024 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?7 U.S. locations

Locations may change over time.

Who runs it?Aminex Therapeutics, Inc.

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1 / Phase 2
Sponsor: Aminex Therapeutics, Inc.
Interventions being studied: Drug: AMXT1501; Drug: DFMO

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→Mesothelioma→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

IMPORTANT NOTE- Younger 12-17 year old patients are also eligible for this study if they meet the noted DIPG or DMG criteria noted below, which is separate from Patient Diagnosed with Advanced Solid Tumors.
Patients will be eligible for study participation only if they meet ALL the inclusion criteria applicable to their diagnosis. INCLUSION FOR PATIENTS DIAGNOSED WITH ADVANCED SOLID TUMORS
Understand and sign written IRB-approved informed consent form and be willing to comply with all study procedures.
Diagnosed with unresectable, locally advanced, or metastatic solid tumor for which no standard therapy is recognized or for which standard therapy has failed. Planned tumor types for evaluation include:
Platinum resistant ovarian cancer (including - primary peritoneal cancer and fallopian tube cancer)
Breast cancer
Papillary thyroid cancer
Head and neck cancer
Gastric cancer
Non-small cell lung cancer (NSCLC)
Mesothelioma: Pleural and peritoneal
Esophageal
Endometrial cancer
Cervical
Melanoma
Colorectal cancers (colon, rectal)
Grade 4 Gliomas (including both IDH WT and IDH-mutant astrocytoma)
Must be ≥18 years of age.
Histologically or cytologically documented disease.
Has evaluable or measurable disease by RECIST v1.1 or mRECIST criteria. o For patients with Grade 4 glioma, has evaluable or measurable disease by RANO (Appendix 5).
Provide tumor tissue from biopsy taken during Screening period.
Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale. INCLUSION FOR PATIENTS DIAGNOSED WITH DIPG OR DMG Patients must also meet other generally noted criteria as noted within the protocol
For patients \<18 years of age, the parents or legal guardians must understand and sign the written IRB-approved informed consent form (ICF). The patient, if able, must understand and sign the IRB-approved consent (assent) and be willing to comply with all study procedures. o For patients ≥18 years of age, the patient must understand and sign written IRB-approved ICF and be willing to comply with all study procedures.
Diagnosed with DIPG or DMG. o Any anatomic site of origin is acceptable.
Must be ≥12 years of age and \>40 kg in body weight.
Radiologically documented disease.
(a) - Patient with refractory or progressive DIPG or DMG, defined as tumors with a pontine epicenter and diffuse involvement of at least 2/3 of the pons, are eligible without histologic confirmation.
(b) - Patients with brainstem tumors that do not meet radiographic criteria or are not considered to be typical DIPG or DMG will be eligible if the tumors have been biopsied and proven to be high-grade gliomas (such as anaplastic astrocytoma, glioblastoma, H3 K27M-mutant DMG).
Has evaluable or measurable disease by RANO or RAPNO criteria. o Has evaluable or measurable disease by RANO (for adults) or RAPNO (for children
Provide cerebrospinal fluid (CSF) sample. Patients with pontine lesions for whom a radiological diagnosis of DIPG, or DMG is made will be eligible without a CSF sample, although CSF sample is strongly encouraged.
Performance score:
(a) Patients \>16 years of age, Karnofsky score ≥50%.
(b) Patients ≥12 and ≤16 years of age, Lansky ≥50%. Note: Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score. INCLUSION FOR ALL PATIENTS All patients are required to meet these inclusion

Reasons someone may not be able to joinExclusion criteria

to be considered eligible for the study
Patients must have fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy: The following minimum periods from treatment apply:
(a) Myelosuppressive chemotherapy: At least 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea).
(b) Hematopoietic growth factors: At least 14 days after the last dose of a long-acting growth factor (e.g., Neulasta) or 7 days for short-acting growth factor.
(c) Biologic (anti-neoplastic agent): At least 7 days after the last dose of a biologic agent. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur.
(d) Immunotherapy: At least 42 days after the completion of any type of vaccination.
(e) Monoclonal antibodies: \>21 days must have elapsed from the infusion of last dose of antibody and toxicity related to antibody therapy must be recovered to Grade ≤1.
(f) Radiation therapy: Patients must have had their last fraction of craniospinal or focal irradiation a minimum of 8-12 weeks prior to enrollment.
(g) Stem cell transplant: Patients must be ≥3 months since autologous stem cell transplant. Patients who received allogenic stem cell transplant or solid organ transplant are not eligible for study.
Patient is able to take oral medications and willing to use an at-home infusion pump.
Must have adequate bone marrow and renal/hepatic function at the screening and baseline visits, defined as:
(a) Absolute neutrophil count (ANC) ≥1.5×109/L without granulocyte colony-stimulating factor (G-CSF) support within 7 days
(b) Platelet ≥100×109/L, without transfusion within 7 days
(c) Hemoglobin ≥9 g/dL, without transfusion support within 7 days
(d) Activated partial thromboplastin time/ partial thromboplastin time (aPTT/PTT) ≤1.5×ULN.
(e) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN (if liver metastases are present, then ≤5×ULN is allowed).
(f) Total serum bilirubin ≤1.5×ULN, (except for patients with known Gilbert's Syndrome in whom ≤3×ULN is permitted).
(g) The patient is clinically euthyroid.
(h) Renal: Serum creatinine \<1.5×ULN or creatinine clearance ≥60 mL/min/1.73 m2 for patients with serum creatinine levels \>1.5×ULN.
(i) Any Grade 3 or higher lab abnormalities should be discussed and approved by the Medical Monitor prior to enrollment (even if not considered clinically significant).
Active secondary malignancies will not be allowed, with the exception of:
(a) Adequately treated basal cell carcinoma, SCC of the skin, or in situ cervical cancer;
(b) Adequately treated Stage 1 cancer from which the subject is currently in remission and has been in remission for ≥2 years;
(c) Low-risk prostate cancer with Gleason score \<7 and prostate-specific antigen \<10 ng/mL, or
(d) Any other cancer from which the patient has been disease-free for ≥3 years.
Patient compliance and geographic proximity (as determined by the Principal Investigator \[PI\]) to allow adequate follow-up.
Both male and female patients must be willing to consent to using highly effective contraception prior to study entry, while on treatment, and at least 3 months thereafter

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Mayo Clinic - ArizonaPhoenix, Arizona
Mayo Clinic - FloridaJacksonville, Florida
Mayo Clinic - MinnesotaRochester, Minnesota
Cincinnati Children's Hospital Medical CenterCincinnati, Ohio
MD Anderson Cancer CenterHouston, Texas
Fred Hutch Cancer Center - Seattle Cancer Care AllianceSeattle, Washington
Kids Cancer CentreSydney, New South Wales

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 24, 2024. Always confirm current availability with the study team.

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