OncoMatch/Clinical Trials/NCT07287917
Study of AMXT 1501 and DFMO in Combination With Standard Therapies in Advanced Solid Tumors
Is NCT07287917 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments for melanoma (skin cancer).
Treatment: AMXT 1501 Dicaprate · DFMO · Fulvestrant · Capivasertib · Pembrolizumab — 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). The Phase 2 portion will further evaluate clinical activity at the RP2D using response criteria for solid tumors (RECIST 1.1). The study will also evaluate pharmacokinetics, pharmacodynamics, disease control, and overall safety.
Check if I qualifyExtracted eligibility criteria
Cancer type
Melanoma
Breast Carcinoma
Biomarker criteria
Required: PIK3CA alteration
breast cancer with one or more actionable PIK3CA/AKT1/PTEN-alterations
Required: AKT1 alteration
breast cancer with one or more actionable PIK3CA/AKT1/PTEN-alterations
Required: PTEN alteration
breast cancer with one or more actionable PIK3CA/AKT1/PTEN-alterations
Allowed: BRAF V600 mutation
if BRAF600 mutant positive, a BRAF or mitogen-activated protein kinase (MEK) inhibitor or both
Disease stage
Required: Stage III, IV, STAGE III
Metastatic disease required
unresectable, locally advanced, or metastatic solid tumors ... Has evaluable or measurable disease by tumor Response Evaluable Criteria in Solid Tumors version 1.1 (RECIST 1.1) ... unresectable Stage III or metastatic melanoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: endocrine therapy — metastatic
progression on at least 2 endocrine-based regimens in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy
Must have received: immune checkpoint inhibitor
patients with unresectable metastatic cutaneous melanoma that progressed on any prior immune checkpoint inhibitor
Cannot have received: allogeneic stem cell transplant
Patients who received allogenic stem cell transplant or solid organ transplant are not eligible for study
Cannot have received: solid organ transplant
Patients who received allogenic stem cell transplant or solid organ transplant are not eligible for study
Cannot have received: Adriamycin (Adriamycin)
No prior use of Adriamycin is allowed
Lab requirements
Blood counts
ANC ≥1.5×10^9/L without G-CSF support within 7 days; Platelet ≥100×10^9/L, without transfusion within 7 days; Hemoglobin ≥9 g/dL, without transfusion support within 7 days; aPTT/PTT ≤1.5×ULN
Kidney function
Serum creatinine ≤1.5×ULN or creatinine clearance ≥60 mL/min/1.73 m2 for patients with serum creatinine levels >1.5×ULN
Liver function
AST and ALT ≤2.5×ULN (if liver metastases are present, then ≤5×ULN is allowed); total serum bilirubin ≤1.5×ULN, except for patients with known Gilbert's Syndrome in whom ≤3×ULN is permitted
Adequate organ function defined as: ... see full details in eligibility
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- START Los Angeles · Los Angeles, California
- START Cancer Research New York-Long Island · Lake Success, New York
- University of Texas-MD Anderson · Houston, Texas
- Lumi Research · Houston, Texas
- Laguna Clinical Research Associates · Laredo, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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