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

Part A: Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs)

Time frame: within 2 years of starting treatment

Part A: Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment

Time frame: within 2 years of starting treatment

Part A: Severity of Treatment-Emergent AEs

Categories: NCI-CTCAE version 4 severity criteria

Time frame: within 2 years of starting treatment

Part A: Severity of Laboratory Abnormalities

Categories: NCI-CTCAE version 4 severity criteria

Time frame: within 2 years of starting treatment

Part A and Part B: Percentage of Participants With Treatment Discontinuations or Modifications due to AEs and Laboratory Abnormalities

Time frame: within 2 years of starting treatment

Part A and Part B: Number of Participants With Change From Baseline in Blood Pressure (BP)

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).

Time frame: within 2 years of starting treatment

Part A and Part B: Number of Participants With Change From Baseline in Pulse Rate

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

Time frame: within 2 years of starting treatment

Part A and Part B: Number of Participants With Change From Baseline in Electrocardiogram (ECG) Parameters

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

Time frame: within 2 years of starting treatment

Part A and Part B: Change From Baseline in Left Ventricular Ejection Fraction (LVEF)

Time frame: within 2 years of starting treatment

Part A and Part B: Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG PS)

Time frame: within 2 years of starting treatment

Part A: Number of Participants With Tumour Response, According to Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1 Criteria

Includes: Best overall response, disease control, tumour size

Time frame: within 2 years of starting treatment

Part B: Number of Participants With Tumour Response, According to Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1 Citeria or Response Assessment in Neuro-Oncology (RANO) (for glioblastoma participants)

Includes: Best overall response, disease control, tumour size

Time frame: within 2 years of starting treatment

Part A and Part B: Progression-Free Survival Rate After Treatment Initiation

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

Time frame: within 2 years of starting treatment

Part A and Part B: Number of Participants With Changes in Ophthalmological Exams

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

Time frame: within 2 years of starting treatment

Part A: Area Under Concentration-Time Curve (AUC) Following Single- and Repeated-Dose Administration of Debio 1347

Time frame: Day -9, Day -2, Day 28; Ctrough on Day 8, Day 15, Day 22 of Cycle 1, and on Day 1 of Cycle 2 and Cycle 3

Part A: Concentration at the end of a Dosing Interval (Ctrough) Following Single- and Repeated-Dose Administration of Debio 1347

Time frame: Day -9, Day -2, Day 28; Ctrough on Day 8, Day 15, Day 22 of Cycle 1, and on Day 1 of Cycle 2 and Cycle 3

Part A: Maximum Observed Concentration (Cmax) Following Single- and Repeated-Dose Administration of Debio 1347

Time frame: Day -9, Day -2, Day 28; Ctrough on Day 8, Day 15, Day 22 of Cycle 1, and on Day 1 of Cycle 2 and Cycle 3

Part A: Time of Maximum Concentration (tmax) Following Single- and Repeated-Dose Administration of Debio 1347

Time frame: Day -9, Day -2, Day 28; Ctrough on Day 8, Day 15, Day 22 of Cycle 1, and on Day 1 of Cycle 2 and Cycle 3

Part A: Apparent Terminal Half-Life (t1/2) Following Single- and Repeated-Dose Administration of Debio 1347

Time frame: Day -9, Day -2, Day 28; Ctrough on Day 8, Day 15, Day 22 of Cycle 1, and on Day 1 of Cycle 2 and Cycle 3

Part A: Mean Residence Time (MRT) Following Single- and Repeated-Dose Administration of Debio 1347

Time frame: Day -9, Day -2, Day 28; Ctrough on Day 8, Day 15, Day 22 of Cycle 1, and on Day 1 of Cycle 2 and Cycle 3

Part A: Apparent Clearance (CL/F) Following Single- and Repeated-Dose Administration of Debio 1347

Time frame: Day -9, Day -2, Day 28; Ctrough on Day 8, Day 15, Day 22 of Cycle 1, and on Day 1 of Cycle 2 and Cycle 3

Part A: Apparent Volume of Distribution (Vz/F) Following Single- and Repeated-Dose Administration of Debio 1347

Time frame: Day -9, Day -2, Day 28; Ctrough on Day 8, Day 15, Day 22 of Cycle 1, and on Day 1 of Cycle 2 and Cycle 3

Part A: Accumulation Ratios (RAC) Following Single- and Repeated-Dose Administration of Debio 1347

Time frame: Day -9, Day -2, Day 28; Ctrough on Day 8, Day 15, Day 22 of Cycle 1, and on Day 1 of Cycle 2 and Cycle 3

Part A: Linearity Index (LI) Following Single- and Repeated-Dose Administration of Debio 1347

Time frame: Day -9, Day -2, Day 28; Ctrough on Day 8, Day 15, Day 22 of Cycle 1, and on Day 1 of Cycle 2 and Cycle 3

Part A: Peak-to-Trough fluctuation (PTF) Following Single- and Repeated-Dose Administration of Debio 1347

Time frame: Day -9, Day -2, Day 28; Ctrough on Day 8, Day 15, Day 22 of Cycle 1, and on Day 1 of Cycle 2 and Cycle 3

Part B: Area Under Concentration-Time Curve (AUC), Following Repeated-Dose Administration of Debio 1347 in the PK Subset

Time frame: Day 28

Part B: Concentration at the end of a Dosing Interval (Ctrough) Following Repeated-Dose Administration of Debio 1347 in the PK Subset

Time frame: Day 28

Part B: Maximum Observed Concentration (Cmax) Following Repeated-Dose Administration of Debio 1347 in the PK Subset

Time frame: Day 28

Part B: Time of Maximum Concentration (tmax) Following Repeated-Dose Administration of Debio 1347 in the PK Subset

Time frame: Day 28

Part B: Apparent Terminal Half-Life (t1/2) Following Repeated-Dose Administration of Debio 1347 in the PK Subset

Time frame: Day 28

Part B: Mean Residence Time (MRT) Following Repeated-Dose Administration of Debio 1347 in the PK Subset

Time frame: Day 28

Part B: Apparent clearance (CL/F) Following Repeated-Dose Administration of Debio 1347 in the PK Subset

Time frame: Day 28

Part B: Apparent Volume of Distribution (Vz/F) Following Repeated-Dose Administration of Debio 1347 in the PK Subset

Time frame: Day 28

Part B: Peak-to-Trough Fluctuation (PTF) Following Repeated-Dose Administration of Debio 1347 in the PK Subset

Time frame: Day 28

Part B: Renal Clearance (CLR) Following Repeated-Dose Administration of Debio 1347 in the PK Subset

Time frame: Day 28

Part B: Percentage of the Dose Excreted in Urine (Ae%) Following Repeated-Dose Administration of Debio 1347 in the PK Subset

Time frame: Day 28

Part B: Ctrough in all Participants

Time frame: Day 8, Day 15, Day 22 of Cycle 1, and Day 1 of Cycle 2 and Cycle 3