This study is an open label, two-part, First in Human (FIH) Phase 1/2 dose-finding study designed to determine the safety, tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD) and proof-of-concept (POC) of OMO-103 in patients with advanced solid tumours.
This study is an open label, two-part, FIH Phase 1/2 dose-finding study designed to determine the safety, tolerability, PK, PD and proof-of-concept of OMO-103 in patients with advanced solid tumours. The study consists of two parts: • Part 1: Dose escalation in patients with advanced solid tumours, including 5 OMO-103 dose levels. Approximately 11 to 24 patients in total will be enrolled in Part 1, covering 5 dose levels with the primary objective of determining the safety and tolerability of OMO-103 and defining an appropriate dose for further evaluation in Part 2. The study will start with an accelerated-titration dose-escalation scheme enrolling one evaluable patient per cohort for the first 2 dose levels followed by a classic 3+3 design. • Part 2: Dose expansion where at least 3 parallel groups of patients with advanced Non Small Cell Lung Cancer (NSCLC), Triple Negative Breast Cancer (TNBC) and Colorectal Cancer (CRC) will be treated at the recommended Phase 2 dose (RP2D) of OMO-103 to further characterise the safety, tolerability, PK, PD and anti-tumour activity of OMO-103. Approximately 18 patients will be enrolled in each of the 3 parallel groups of patients (NSCLC, TNBC, CRC) in Part 2.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
OMO-103 will be administered intravenously as 30 min infusion once weekly
University Hospital Vall d´Hebron
Barcelona, Spain
Hospital Fundación Jiménez Díaz
Madrid, Spain
Hospital Universitario HM Sanchinarro
Madrid, Spain
Phase 1: Safety and Tolerability
Phase 1: Number of patients with a DLT; Number of patients with IRRs, AEs /SAEs according to NCI CTCAE v 5;
Time frame: DLT period was 3 weeks and AEs were assessed for each patient until progression which was in average 3 months;
Phase 1: Elimination Half Life (t1/2)
Phase 1: elimination half life (t1/2) was determined via several timepoints from 0 up to 94 hours after end of infusion
Time frame: 0, 5, 30, 60 min, 1, 2, 6, 24, 48, 76, 94 hours after end of infusion
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