Laredo Laguna

Laguna Clinical Research Associates

COVID-19

Hypertension

Melanoma

Breast Cancer

Cancer

Hematologic Cancer

Remdesivir

DFMO

IONIS-AGT-LRx

AMXT 1501

KPG-818

Aminex Therapeutics

Gilead Sciences

Ionis Pharmaceuticals

Kangpu Biopharmaceuticals

condition

allSponsorName

gender

Male

Female

overallStatus

Recruiting

Not yet recruiting

Active, not recruiting

Enrolling by invitation

Completed

Terminated

Withdrawn

Suspended

Unknown

type

Interventional

Observational

Expanded Access

phase

Early Phase 1

Phase 1

Phase 2

Phase 3

Phase 4

Not Applicable

funderTypes

Industry

Other U.S. Federal agency

All others

ageGroup

Child (birth-17)

Adult (18-64)

Older Adult (65+)

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.

Study of AMXT 1501 and DFMO in Combination With Standard Therapies in Advanced Solid Tumors

Laguna Clinical Research Associates | Laredo Laguna

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Study of AMXT 1501 and DFMO in Combination With Standard Therapies in Advanced Solid Tumors

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