OMO-1 in Solid Malignancies

Inclusion Criteria: * Aged at least 18 years * Provision of signed and dated, written informed consent. * Histological or cytological confirmation of locally advanced, unresectable or metastatic solid malignancy. * Performance status: Eastern Co-operative Oncology Group (ECOG) ≤1 and life expectancy ≥3 months. * Ability to swallow and retain oral medication. * Adequate organ functions. * Females of child-bearing potential: * Must use a highly effective method contraceptive measures during the study and for 1 month after the last dose of OMO 1. * Must not be breast feeding. * Must have a negative pregnancy test prior to start of dosing. * Sexually active male patients must be willing to use barrier contraception Exclusion Criteria: * Patients receiving other cancer therapy, or other investigational product apart from the combination agent(s) described in the relevant combination modules. * Patients who have received radiotherapy for the primary tumour within 1 week from the screening visit. * Patients receiving medications predominantly metabolized by CYP2B6. * Patients receiving cannabinoid substances. * Patients receiving St John's Wort. * Patients receiving medications that are known to have potent aldehyde oxidase (AO) inhibitory activity. * Patients with prior splenectomy. * Patients testing positive for human immunodeficiency virus (HIV) infection, hepatitis B based on findings of persistent hepatitis B virus surface antigen (HBsAg) or other serology test, hepatitis C virus (HCV) or Epstein-Barr Virus (EBV) infection. * Patients with current, or a history of uveitis. * Patients with any known uncontrolled inter-current illness including ongoing or active infections, symptomatic congestive heart failure, conditions that could adversely be affected by hypertension or tachycardia, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Patients with a history or clinical evidence of neoplastic central nervous system (CNS) involvement if not stable for 9 weeks prior to the first dose of study treatment. * Patients with major and/or planned surgery within 12 weeks of the first dose of study treatment. * Patients with any known severe allergies (e.g., anaphylaxis) to any active or inactive ingredients in OMO-1. * Patients with nephrolithiasis. * Patients with current, or a history of any seizure or seizure disorder. This includes receiving, or having received, seizure threshold-raising medication for the treatment of epilepsy. In addition to the main core eligibility criteria, Module specific eligibility criteria include: Module 1: Patient recruited into the paired biopsy cohorts of Part A must have: * at least 1 lesion suitable for biopsy. * tumours that are MET gene amplified and/or mutated. * had no prior therapy with a selective MET inhibitor. Patients recruited into Part B cohorts must have: * tumours that are MET gene amplified and/or mutated. * at least one lesion, not previously irradiated, that can be accurately measured at baseline. * had no prior therapy with a selective MET inhibitor. * no coinciding malignancy that would impact on survival. * no metastasis limited to the bone only. Module 2: Patients recruited into Part A and Part B cohorts must have: * tumours that are EGFR gene mutant that are currently progressing on treatment with a small molecule EGFR-TKI. Enrolment must be restricted to patients that are resistant to all relevant EGFR TKI therapy according to their tumour mutated status. * received the EGFR-TKI as monotherapy for at least 12 weeks. * tolerated their current dose of EGFR-TKI for at least 12 weeks. * tumours that are MET gene amplified. * had no prior therapy with a selective MET inhibitor. * had no prior EGFR-TKI treatment of \>2 lines. * no past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD. * no significant GI disorders with diarrhoea as a major symptom e.g., Crohn's disease, mal-absorption, or CTCAE Grade \>1 diarrhoea of any aetiology at the enrolment. * no contra-indications (as per the relevant medication package insert) for therapy with the EGFR-TKI routinely used by their oncology unit. In addition, patients recruited into Module 2 Part B cohorts must have: * at least one lesion, not previously irradiated, that can be accurately measured at baseline as ≥10 mm in the longest diameter (except lymph nodes which must have short axis ≥15 mm) with CT or MRI and which is suitable for accurate repeated assessment. * no coinciding malignancy that would impact on survival. * no metastasis limited to the bone only.

Reproduced word-for-word from the public registry record — the study team can answer questions about it.