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Adaptive doses of Debio1347 (CH5183284) - (10 mg to 210 mg/day) until the recommended dose (RD) is determined.

Participants with various tumours receive Debio1347 (CH5183284) orally at the recommended dose established during Part A.

Debio1347 (CH5183284) tablets for oral administration

Debio1347 (CH5183284)

This study is primarily designed to assess the safety and the tolerability of Debio1347 (CH5183284) in patients with advanced solid malignancies, whose tumours have an alteration of the Fibroblast Growth Factor Receptor (FGFR) 1, 2 or 3 genes, for whom standard treatment does not exist or is not indicated.

The main objective of Part A is to identify the dose-limiting toxicities (DLTs) and estimate the maximum tolerated dose (MTD) based on the safety and tolerability of Debio1347 orally administered daily to these patients, in order to determine the recommended dose.

The main objective of Part B is to evaluate the safety profile at the recommended dose, in a larger cohort of these patients.

Debio 1347-101 Phase I Trial in Advanced Solid Tumours With Fibroblast Growth Factor Receptor (FGFR) Alterations

A Phase I, Gene Alteration-based, Open Label, Multicenter Study of Oral Debio 1347 (CH5183284) in Patients With Advanced Solid Malignancies, Whose Tumours Have an Alteration of the FGFR 1, 2 or 3 Genes

Categories: NCI-Common Terminology Criteria for Adverse Events (CTCAE) version 4 severity criteria

Categories: NCI-CTCAE version 4 severity criteria

Change in BP will be evaluation based on three criteria- "Change to Low" (decrease from pre-treatment \> 20 millimeter of mercury \[mmHg\]), "No change" (change from pre-treatment within ± 20 mmHg) and "Change to High" (increase from pre-treatment \> 20 mmHg).

Number of participants with change of more than 20 beats per minute from baseline will be reported.

ECG parameters will include PR, RR, QRS, QTcB and QTcF intervals.

Includes: Best overall response, disease control, tumour size

Categories: overall, 6 months, 1 year, 2 years

Opthalmological exams includes visual acuity testing, slit-lamp ophthalmoscopy and indirect ophthalmoscopy.

Spots Global Cancer Trial Database for debio1347 (ch5183284)