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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-514554-75-00

Acronym

OMX-0407-101

Enrollment

224

Registered

2024-09-23

Start date

2023-03-16

Completion date

Unknown

Last updated

2025-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Previously treated unresectable solid tumours

Brief summary

Dose escalation phase : Incidence of DLTs attributable to OMX-0407 at each dose level. Cohort expansion phase : ORR. Tumour assessments will be performed at baseline and following every 12 weeks. For cutaneous AS cohort, images will be independently assessed. Responses will be defined according to immune-modified Response Evaluation Criteria in Solid Tumours (iRECIST).

Interventions

None listed

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Dose escalation phase : Incidence of DLTs attributable to OMX-0407 at each dose level. Cohort expansion phase : ORR. Tumour assessments will be performed at baseline and following every 12 weeks. For cutaneous AS cohort, images will be independently assessed. Responses will be defined according to immune-modified Response Evaluation Criteria in Solid Tumours (iRECIST).	—

Countries

Belgium, France, Spain

Outcome results