cKIT-positive Solid Tumors

LOP628

Novartis Investigative Site

Phase 1 Study of LOP628 in Adult Patients With cKit-positive Solid Tumors and Acute Myeloid Leukemia

A Phase I, Multicenter, Open-label Dose Escalation and Expansion Study of LOP628, Administered Intravenously in Adult Patients With cKit-positive Tumors and Acute Myeloid Leukemia

To estimate the maximum tolerated dose/recommended dose for expansion (MTD/RDE)

Characterize the safety and tolerability of LOP628

To characterize the pharmacokinetic profile of LOP628

To characterize the pharmacokinetic profile of LOP628.

To assess the preliminary anti-tumor activity of LOP628

To assess the preliminary anti-tumor activity of LOP628 in patients

Novartis Pharmaceuticals

After an imaging phase, the patient will receive T-DM1 iv every 3 weeks until progression or toxicity

HER-2 Positive Breast Cancer

T-DM1

Injection of 89Zr-trastuzumab for HER2 imaging

89Zr-trastuzumab

Universitair Ziekenhuis Antwerpen (UZA)

Institut Jules Bordet

Vrije Universiteit Amsterdam (VUMC)

University Medical Center Groningen (UMCG)

Radboud University Medical Centre Nijmegen (UMCN)

HER2 Imaging Study to Identify HER2 Positive Metastatic Breast Cancer Patient Unlikely to Benefit From T-DM1

Phase II Prospective Imaging Study Evaluating the Utility of Pre-treatment zr89 Labelled Trastuzumab PET/CT and an Early FDG-PET/CT Response to Identify Patients With Advanced HER2+ BC Unlikely to Benefit From a Novel antiHER2 Therapy: TDM1

The primary objective is to show that pre-treatment 89Zr-trastuzumab PET/CT is able to select lesions not responding morphologically from treatment with T-DM1 (applying RECIST 1.0 criteria).

The first secondary objective is to show that early FDG PET/CT (performed after one cycle of T-DM1 just before the second cycle) is able to select lesions not responding from treatment with T-DM1 according to metabolic and morphological response criteria post 3 cycles of T-DM1.

The second secondary objective is to show that 89Zr-trastuzumab PET/CT is able to select lesions not responding from treatment with T-DM1 according to metabolic response criteria post 3 cycles of T-DM1.

The third secondary objective is to show that a lesion with no/faint uptake on 89Zr-trastuzumab PET/CT and not responding metabolically on the early FDG-PET/CT will not respond according to metabolic and morphological criteria after 3 cycles of T-DM1.

maytansine/سرطان

Phase 1 Study of LOP628 in Adult Patients With cKit-positive Solid Tumors and Acute Myeloid Leukemia

HER2 Imaging Study to Identify HER2 Positive Metastatic Breast Cancer Patient Unlikely to Benefit From T-DM1

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