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New treatment option for Melanoma (Skin Cancer)
Official title Study of AMXT 1501 and DFMO in Combination With Standard Therapies in Advanced Solid Tumors
ClinicalTrials.gov ID: NCT07287917
What this study is testing
What is AMXT 1501 Dicaprate?
AMXT 1501 Dicaprate is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for melanoma (skin cancer).
Also referred to as AMXT 1501.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study will evaluate the safety, tolerability, and preliminary effectiveness of AMXT 1501 and DFMO when combined with standard treatments for advanced solid tumors. The trial includes two groups: Cohort 1: Patients with ER+ / HER2- breast cancer receiving fulvestrant and capivasertib Cohort 2: Patients with unresectable or metastatic cutaneous melanoma receiving pembrolizumab The Phase 1b portion will find the recommended Phase 2 dose (RP2D).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients will be eligible for study participation only if they meet ALL the applicable to their diagnosis.
- Understand and sign the informed consent form (ICF) and be willing to comply with all study procedures before any study specific procedures are...
- ≥18 years old at the time of signing the informed consent.
- Diagnosed with unresectable, locally advanced, or metastatic solid tumors including ER+ HER2- breast cancer (Cohort 1) or melanoma (Cohort 2)...
- Patients must be willing to undergo a fresh tumor biopsy at Screening and during treatment if safe and clinically feasible. An archival sample is...
You likely can't join if
- Patients will not be eligible for study participation if they meet ANY of the exclusion criteria.
- Patients with melanoma only: i. Radiation therapy, or biological cancer therapy within 4 weeks prior to the first dose of study drug, or not...
- Intolerant to any component of combination or standard of care therapies.
- History or presence of clinically relevant central nervous system (CNS) pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain...
- Active inflammatory neurological disorders (e.g., Guillain-Barre Syndrome, amyotrophic lateral sclerosis, multiple sclerosis).
- Treatment with radiation therapy, surgery, chemotherapy, or immunotherapy within 4 weeks prior to study entry (6 weeks for nitrosoureas or Mitomycin...
See the full eligibility criteria
Who can join
- Patients will be eligible for study participation only if they meet ALL the applicable to their diagnosis.
- Understand and sign the informed consent form (ICF) and be willing to comply with all study procedures before any study specific procedures are conducted.
- ≥18 years old at the time of signing the informed consent.
- Diagnosed with unresectable, locally advanced, or metastatic solid tumors including ER+ HER2- breast cancer (Cohort 1) or melanoma (Cohort 2) a.Underlying malignant disease must be histologically or cytologically...
- Patients must be willing to undergo a fresh tumor biopsy at Screening and during treatment if safe and clinically feasible. An archival sample is allowed if obtained within 1 year prior to the first dose of study drug...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at Screening or Day 1.
- Life expectancy of at least 12 weeks.
- Adequate organ function defined as: a.Absolute neutrophil count (ANC) ≥1.5×109/L without granulocyte colony-stimulating factor (G-CSF) support within 7 days preceding the laboratory assessment b.Platelet ≥100×109/L...
- Fully recovered from acute toxic effects of prior anti-neoplastic therapies. The following minimum periods from treatment apply:
- Myelosuppressive chemotherapy: At least 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea).
- 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.
- 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...
- Active secondary malignancies will not be allowed, with the exception of: a.Adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or in situ cervical cancer b.Adequately treated Stage 1 cancer...
- Patient compliance and geographic proximity (as determined by the Investigator) to allow adequate follow-up.
- Both male and female patients must be willing to consent to using highly effective contraception (refer to Section 9.1.10) prior to study entry, while on treatment, and at least 3 months thereafter.
- Able to take oral medications.
What rules you out
- Patients will not be eligible for study participation if they meet ANY of the exclusion criteria.
- Patients with melanoma only: i. Radiation therapy, or biological cancer therapy within 4 weeks prior to the first dose of study drug, or not recovered from the AEs due to cancer therapies administered more than 4 weeks...
- Intolerant to any component of combination or standard of care therapies.
- History or presence of clinically relevant central nervous system (CNS) pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic...
- Active inflammatory neurological disorders (e.g., Guillain-Barre Syndrome, amyotrophic lateral sclerosis, multiple sclerosis).
- Treatment with radiation therapy, surgery, chemotherapy, or immunotherapy within 4 weeks prior to study entry (6 weeks for nitrosoureas or Mitomycin C). No prior use of Adriamycin is allowed. Limited prior palliative...
- Targeted small molecule therapy within 7 days prior to initiation of trial therapy. Chemotherapy within 14 days prior to initiation of trial therapy.
- Active autoimmune disease (e.g., lupus, rheumatoid arthritis, Sjogren's syndrome) requiring systemic treatment (i.e., disease modifying agents, corticosteroids, or immunosuppressive drugs) in the past 2 years...
- History of or presence of clinically significant cardiovascular disease, e.g., a. Inadequately controlled or uncontrolled hypertension (defined as systolic blood pressure \>150 mmHg and/or diastolic blood pressure \>100...
- History or presence of ECG abnormalities, e.g., a. Congenital or acquired prolonged QTc. Screening QTcF \> 450ms is excluded. b. Bundle branch block including right or left bundle branch block, left anterior or...
- 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. a.Women not OCBP is defined as: i.Postmenopausal with \>1...
- Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
- Has received radiation therapy to the lung that is \>30 Gy within 6 months of the first dose of trial treatment.
- Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- Has history of an allogeneic stem cell transplant or a solid organ transplant.
- Has a history of radiation pneumonitis. (Note: Cannot receive prior radiotherapy within 2 weeks of start of pembrolizumab. Note: Participants must have recovered from all radiation-related toxicities and not require...
The study team makes the final eligibility decision.
Where it's taking place
- Tucson, Arizona, United States
- Los Angeles, California, United States
- Englewood, Colorado, United States
- Detroit, Michigan, United States
- Maple Grove, Minnesota, United States
- Lake Success, New York, United States
- Cincinnati, Ohio, United States
- Nashville, Tennessee, United States
- Austin, Texas, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Laredo, Texas, United States
- West Valley City, Utah, United States
- Fairfax, Virginia, United States
- Madison, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tucson, Arizona, United States; Los Angeles, California, United States; Englewood, Colorado, United States; Detroit, Michigan, United States; Maple Grove, Minnesota, United States; Lake Success, New York, United States and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.