Oral AMXT 1501 Dicaprate in Combination With IV DFMO

Stopped early · Phase 1/Phase 2

Conditions studied: Cancer, Solid Tumor, Solid Carcinoma, Advanced Cancer, DIPG Brain Tumor, Ovary Cancer, Breast Cancer, Papillary Thyroid Cancer, Head and Neck Cancer, Gastric Cancer, Nsclc, Mesotheliomas Pleural, Mesothelioma Peritoneum, Esophageal Cancer, Diffuse Midline Glioma, H3 K27M-Mutant, Endometrial Cancer, Cervical Cancer, Melanoma, Colorectal Cancer, Glioma, Malignant

In brief

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.

Key facts

Study ID: NCT05500508
Run by: Aminex Therapeutics, Inc.
People needed: 15
Starts: 2022-11-29
Expected to finish: 2024-12-12
Last updated by the study team: 2024-12-24

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

Patients will not be eligible for study participation if they meet ANY of the exclusion criteria.
Please note different criteria for patients with Advanced Solid Tumors (adults) vs patients with DIPG or DMG (pediatric)
EXCLUSION FOR PATIENTS DIAGNOSED WITH ADVANCED SOLID TUMOR(S)
Have a seizure disorder where >1 seizure has occurred within the last year.
Patient with treated (surgically excised or irradiated) with stable brain metastases are eligible as long as the treatment was at least 4 weeks prior to initiation of study drug and baseline brain CT with contrast or magnetic resonance imaging (MRI) within 2 weeks of initiation of study drug is negative for new brain metastases. Patients with stable brain metastases must not require therapy with corticosteroids.
Treatment with radiation therapy, surgery, chemotherapy, or immunotherapy within 4 weeks prior to study entry (6 weeks for nitrosoureas or Mitomycin C). Limited prior palliative radiation may be permissible no less than 2 weeks prior to C1D1 with approval from the Medical Monitor.
EXCLUSION FOR PATIENTS WITH DIPG OR DMG
Patients with seizure disorders may be enrolled if seizures are well-controlled, defined as no increase in seizure frequency in the prior 7 days.
Anticonvulsants should be used as clinically indicated.
The use of enzyme inducing anticonvulsants is not permitted.
EXCLUSION FOR ALL PATIENTS
Patients with treated (surgically excised or irradiated) stable brain metastases are eligible as long as the treatment was at least 8 to 12 weeks prior to initiation of study drug and baseline brain CT with contrast or MRI within 2 weeks of initiation of study drug is negative for new brain metastases. Patients with brain metastases or who have Grade 4 glioma receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible.
Have clinically significant cardiovascular disease (e.g., significant cardiac conduction abnormalities, uncontrolled hypertension, myocardial infarction, cardiac arrhythmia or unstable angina, New York Heart Association Grade 3 or greater congestive heart failure, serious cardiac arrhythmia requiring medication, Grade 2 or greater peripheral vascular disease, or history of cerebrovascular accident [CVA]) within 6 months of enrollment.
History or presence of an abnormal ECG that, in the Investigator's opinion, is clinically meaningful.
Screening QTcF interval >480 ms is excluded. In the event that a single QTcF is >480 ms, the patient may enroll if the average QTcF for the 3 ECGs is <480 ms.
For patients with an intraventricular conduction delay (QRS interval >120 ms), the JTc interval may be used in place of the QTcF with Sponsor approval. The JTc must be <340 ms if JTc is used in place of the QTcF.
Patients with an intraventricular delay due to a left bundle branch block are excluded.
Note: QTcF prolongation due to pacemaker may enroll if the JTc is normal
Had major surgery, other than diagnostic surgery, within 4-weeks prior to Day 1.
Have active bacterial, viral, or fungal infections requiring systemic therapy.
Women who are pregnant or lactating: NOTE: Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 1 week prior to treatment.
Women not OCBP is defined as
(i) Postmenopausal with >1 year since last menses
-- (a) If <65 years old, follicle-stimulating hormone (FSH) >40 mIU/mL.
-- (b) If ≥65 years old and not on hormone replacement therapy (HRT), FSH >30 mIU/mL.

Where it is running

Mayo Clinic - Arizona — Phoenix, Arizona, United States
Mayo Clinic - Florida — Jacksonville, Florida, United States
Mayo Clinic - Minnesota — Rochester, Minnesota, United States
Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
MD Anderson Cancer Center — Houston, Texas, United States
Fred Hutch Cancer Center - Seattle Cancer Care Alliance — Seattle, Washington, United States
Kids Cancer Centre — Sydney, New South Wales, Australia

Full record on ClinicalTrials.gov

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