Abstract 107TiP
Background
CIS-DPI is a cisplatin-based dry powder for inhalation presenting an innovative approach for the treatment of patients with lung cancer. Thanks to its mode of administration (pulmonary route), CIS-DPI overcomes severe systemic toxicities observed with conventional iv chemotherapy and aims at increasing the efficacy of the current standard of care (SoC) treatment via (i) a daily local targeting of the tumour and (ii) a synergistic potential with immunotherapy, in particular through the immunogenic properties of CIS-DPI.
Trial design
This phase I/IIa study aims to investigate the safety, tolerability, pharmacokinetics and anti-tumour activity of ascending doses of CIS-DPI in combination with SoC treatment in adult patients with treatment-naïve stage IV NSCLC. Patients are enrolled into two populatons: Population 1 includes patients with PD-L1 tumour proportion score (TPS) ≥50%; Population 2 includes patients with PD-L1 TPS <50%. CIS-DPI is administered by inhalation, at home, 5 times weekly (5 days on followed by 2 days off) in addition to 4 cycles of SoC treatment (i.e., iv pembrolizumab for population 1, iv pembrolizumab and carboplatin-doublet chemotherapy for population 2). Each study population undergoes two phases. The first phase consists of a dose escalation (10 patients per population), aiming to determine the maximum tolerated dose and/or the recommended phase II dose (RP2D). The first set of patients will be treated for 14 weeks and undergo an adaptive intra-patient dose titration of CIS-DPI (maximum 3 different dose levels tested per patient) in combination with their SoC treatment. Once the RP2D is established, a safety expansion phase (6 patients per population) at the RP2D will be started, for collection of additional safety information. This set of patients will be treated for 12 weeks with CIS-DPI at the RP2D in combination with their SoC treatment. The first patient was enrolled on the October 16th 2023.
Clinical trial identification
EU trial number: 2022-501183-17-00.
Legal entity responsible for the study
InhaTarget Therapeutics.
Funding
InhaTarget Therapeutics.
Disclosure
M. Brandão: Financial Interests, Personal, Invited Speaker, Speaker at a symposium at the AORTIC Conference 2019: Roche; Financial Interests, Institutional, Invited Speaker, December 2021: Janssen; Financial Interests, Institutional, Advisory Board, 03/2023: Sanofi; Financial Interests, Institutional, Invited Speaker, 01/2023: Takeda; Financial Interests, Institutional, Invited Speaker, 05/2023: Pfizer; Financial Interests, Institutional, Invited Speaker: AstraZeneca, Roche, Boehringer, Sanofi; Non-Financial Interests, Personal, Leadership Role, EORTC Lung Cancer Group - Young and Early Career group Chair (since January 2022): EORTC. S. Holbrechts: Financial Interests, Institutional, Other, Travel grant: Roche, Takeda; Financial Interests, Institutional, Advisory Board: Roche, AstraZeneca, BMS, Leo Pharma; Financial Interests, Institutional, Principal Investigator: PharmaMar, Iteos, AstraZeneca, BMS, InhaTarget Therapeutics. W. Sonnet: Financial Interests, Personal, Stocks/Shares: InhaTarget Therapeutics; Financial Interests, Personal, Full or part-time Employment: InhaTarget Therapeutics. S. Fung: Financial Interests, Personal, Advisory Board: InhaTarget Therapeutics, Simbec-Orion; Financial Interests, Personal, Stocks/Shares: InhaTarget Therapeutics; Financial Interests, Personal, Member of Board of Directors: Molecure SA; Financial Interests, Personal, Member of Board of Directors, (Roca Therapeutics, IOME Bio, BiPER): Landmark BioVentures. R. Rosière: Financial Interests, Personal, Stocks/Shares: InhaTarget Therapeutics; Financial Interests, Personal, Officer: InhaTarget Therapeutics; Financial Interests, Personal, Licensing Fees: InhaTarget Therapeutics. F. De Coninck: Financial Interests, Personal, Officer: InhaTarget Therapeutics; Financial Interests, Personal, Member of Board of Directors: InhaTarget Therapeutics; Financial Interests, Personal, Stocks/Shares: InhaTarget Therapeutics. T. Berghmans: Financial Interests, Institutional, Advisory Board: InhaTarget Therapeutics, Bayer, Janssen, Roche; Financial Interests, Institutional, Principal Investigator: Pfizer, Merck, AstraZeneca, Novartis, Peregrine, Amgen, Novocure; Financial Interests, Institutional, Other, Travel grant: Takeda.