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MTH1, A Phase I, Study on Tumors Inhibition, First in Human, First in Class

NCT03036228 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2025-09-09

No results posted yet for this study

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

DRUG

Karonudib

Dose escalation of administration with Karonudib.

Sponsors & Collaborators

  • Thomas Helleday Foundation

    lead OTHER

Principal Investigators

  • Maria Klockare, BSc · Oxcia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-14
Primary Completion
2024-12-17
Completion
2024-12-17

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03036228 on ClinicalTrials.gov