Trials / Completed
CompletedNCT03036228
MTH1, A Phase I, Study on Tumors Inhibition, First in Human, First in Class
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 63 (actual)
- Sponsor
- Thomas Helleday Foundation · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
Primary Objective • To determine the safety and tolerability of Karonudib (TH1579) in escalating doses for the treatment of patients with advanced solid malignant tumours. Secondary Objective * To define DLT and MTD. * To determine a recommended phase 2 dose (RP2D) and schedule. * To determine the pharmacokinetics of Karonudib. * To determine preliminary signs of clinical efficacy of Karonudib. * To determine overall survival.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Karonudib | Dose escalation of administration with Karonudib. |
Timeline
- Start date
- 2017-01-14
- Primary completion
- 2024-12-17
- Completion
- 2024-12-17
- First posted
- 2017-01-30
- Last updated
- 2025-09-09
Locations
3 sites across 1 country: Sweden
Source: ClinicalTrials.gov record NCT03036228. Inclusion in this directory is not an endorsement.