A Phase I/Ib Dose Escalation and Cohort Expansion Study of OMX-0407 a Salt-inducible Kinase Inhibitor in Patients With Previously Treated Unresectable Solid Tumours

iOmx Therapeutics AG24 sites in 3 countries68 target enrollmentMarch 30, 2023

ConditionsSolid Tumor

InterventionsOMX-0407

Overview

Phase: Phase 1
Intervention: OMX-0407
Conditions: Solid Tumor
Sponsor: iOmx Therapeutics AG
Enrollment: 68
Locations: 24
Primary Endpoint: Identify Dose Limiting Toxicities
Status: Terminated
Last Updated: 8 days ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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,

Registry

clinicaltrials.gov

Start Date

March 30, 2023

End Date

April 2, 2026

Last Updated

8 days ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

iOmx Therapeutics AG

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•General Inclusion Criteria for Cohort Expansion Phases
•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
•Subjects treated in the cohort expansion phase of the study should have an ECOG Performance status of 0 or
•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-
•Male subjects who have previously undergone vasectomy are not required to use contraception.

Exclusion Criteria

•for Cohort Expansion Phases
•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.
•Creatinine clearance by Cockcroft-Gault formula or local equivalent \< 30 ml/min.

Arms & Interventions

OMX-0407 - Escalation Phase

A starting daily dose of 20 mg OMX-0407 per participant split into twice daily 10 mg. Dose escalation will be determined by the safety monitoring committee. Dose for expansion will be determined by the safety monitoring committee.

Intervention: OMX-0407

OMX-0407 - Expansion Phase (Phase Ib)

A dose of 100 mg OMX-0407 will be orally administered twice daily.

Intervention: OMX-0407

Outcomes

Primary Outcomes

Identify Dose Limiting Toxicities

Time Frame: 4 weeks (1 cycle)

Incidence of dose limiting toxicities at each dose level

Identify objective response rate

Time Frame: Every 12 weeks (3 cycles)

Number of objective responses of OMX-0407 in patients with Renal Cell cancer, Non small cell lung cancer, urothelial cancer and angiosarcoma

Secondary Outcomes

Maximum Tolerated Dose(evaluated up to approximately 3 years)
Investigate the safety and tolerability of OMX-0407(through study completion, estimated up to approximately 3 years)
Pharmacokinetics (Cmax) of OMX-0407(evaluated up to approximately 3 years)
Pharmacokinetics (Tmax) of OMX-0407(evaluated up to approximately 3 years)
Pharmacokinetics (AUClast) of OMX-0407(evaluated up to approximately 3 years)
Pharmacokinetics (AUCinf) of OMX-0407(evaluated up to approximately 3 years)
Pharmacokinetics (% extrapolated-AUCinf) of OMX-0407(evaluated up to approximately 3 years)
Pharmacokinetics (t½) of OMX-0407(evaluated up to approximately 3 years)
Measure Duration of Response(every 12 weeks (3 cycles))
Measure Progression Free Survivial(every 12 weeks (3 cycles))
Measure Overall Response Rates(every 12 weeks (3 cycles))
Measure Overall Survival(every 12 weeks (3 cycles))
Assess Quality of Life(Every 4 weeks (1 cycle))