A Study of OMX-0407 in Patients With Previously Treated Solid Tumours That Can't be Removed Surgi… (NCT05826600) | Clinical Trial Compass
TerminatedPhase 1/2
A Study of OMX-0407 in Patients With Previously Treated Solid Tumours That Can't be Removed Surgically
Stopped: Study terminated as part of strategic considerations and not based on safety concerns.
Belgium, France68 participantsStarted 2023-03-30
Plain-language summary
The main purpose of the dose escalation phase of the study is to determine the safety of different doses of OMX-0407.
The dose expansion (phase Ib) part of the study will evaluate efficacy, safety and tolerability at a dose determined in the dose escalation,
Who can participate
Age range16 Years
SexALL
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Inclusion criteria
✓. Age ≥18 years (≥16 years for the AS expansion cohort) and willing to provide informed consent for the study.
✓. Cytological or pathological confirmation of advanced cancer.
✓. Subjects treated in three subject cohorts onwards will be required to provide either archival tumour material or be willing to undergo a core biopsy to provide tumour material during screening.
✓. Subjects should have completed or be unsuitable for licensed therapies for their primary cancer unless such therapies are not available according to local practice - for example not reimbursed or included in treatment guidelines. All subjects must have received at least one previous line of systemic therapy for the tumour type under investigation. Subjects who have declined treatment or according to their treating physician are unsuitable for an existing licensed therapy are eligible for the study.
✓. Eastern Cooperative Oncology Group (ECOG) Performance status 0, 1 or 2. Subjects treated in the cohort expansion phase of the study should have an ECOG Performance status of 0 or 1.
✓. Able to swallow oral medication with no existing evidence of underlying gastrointestinal malabsorption or abnormal gastrointestinal transit.
✓. For female subjects and male partners of childbearing potential, willingness and able to use two forms of highly effective contraception methods (e.g., oral contraceptive and condom, intra-uterine device, and condom) while on study and for 30 days after the last study treatment. For male subjects and female partners of childbearing potential, willingness and able to use two forms of highly effective contraception methods (e.g., oral contraceptive and condom, intra-uterine device, and condom) while on study and for 3 months after the last study treatment. Women who last experienced menses more than one year previously or who have undergone bilateral ovariectomy, hysterectomy or tubal ligation which is documented in their medical notes do not require to use contraception during or after treatment with OMX-0407. Male subjects who have previously undergone vasectomy are not required to use contraception.
✓. All toxicity from previous anti-cancer therapy including radiotherapy must have recovered to either Grade I or stable Grade II (CTCAE v5).
Exclusion criteria
✕. Untreated CNS metastases. Subjects with CNS metastases that have completed treatment at least two weeks previously and have either an unchanging or no neurological deficit whilst not receiving corticosteroid therapy are eligible. Subjects with known CNS metastases must have received CNS directed therapy and not systemic therapy alone to be eligible for the study.
✕. Either Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) \> 2.5 upper limit of normal (ULN) unless in the presence of hepatic metastases when AST or ALT as high as 5 ULN is acceptable. Serum bilirubin \> 1.5 ULN unless in the presence of hepatic metastases when serum bilirubin as high as 3 x ULN is acceptable. Subjects with isolated increases in alkaline phosphatase (ALK) are eligible for the study.
✕. Prothrombin Time or equivalent such as international normalized ratio (INR) or the Quick test \> 1.5 ULN.
✕. Activated Partial Thromboplastin Time (PTT) \> 1.5 ULN.
✕. Chronic anticoagulant therapy that cannot be discontinued for tumour biopsy if necessary.
✕. Previous biological or unlicensed anticancer therapy within five half-lives or thirty days of treatment - whichever is shortest.
✕. Prior cytotoxic chemotherapy in the preceding three weeks.
✕. Persistent fever or other signs of uncontrolled infection.