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Karonudib is an oral inhibitor of MTH1 and will be supplied as an oral solution or tablets to be taken BID. Each cycle is defined as 28 days.

Dose escalation of administration with Karonudib.

Karonudib

Teresa Sandvall, MSc

Jeffrey Yachnin, MD, PhD

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.

13 different dose cohorts with escalating doses are planned.

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

Dose Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD). DLTs will be assessed during first cycle of therapy, week 1-4 based on Haematological toxicity and Non-haematological toxicity.

MTD: The highest dose of Karonudib that does not cause unacceptable side effects is defined as the MTD.

Tmax, time is the time to reach Cmax (Peak Plasma Concentration)

Thomas Helleday Foundation

Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Heart and Blood Diseases

Rare Diseases

Leukemia

Lymphoma

Multiple Myeloma

Neoplasms, Plasma Cell

Hematologic Neoplasms

Lymphoma, B-Cell

Neoplasms by Histologic Type

Hematologic Diseases

B-cell Lymphoma

Lymphosarcoma

Karonudib is an oral inhibitor of MTH1 and will be supplied as an oral solution to be taken every other day. There are three planned dose cohorts. Patients will be given every second day dosing.

Dose escalation of administration with Karonudib. Three different dose cohorts are planned.

Stefan Deneberg, MD, PhD

Stefan Deneberg, MD

The primary objective of this study is to determine safety and tolerability of Karonudib for the treatment of hematological malignancies.

Secondary objectives are to determine a recommended RP2D and schedule for further development of Karonudib, to determine the pharmacokinetics of Karonudib, to look for evidence of treatment efficacy. Overall survival will also be recorded.

3 different dose cohorts with escalating doses are planned.

A Study in Leukemia Patients With Karonudib

A Phase 1 Study in Patients With Hematological Malignancies to Evaluate Safety, Tolerability and Efficacy of Karonudib

Grade and frequency of AE and SAE using the CTCAE version 5.0

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
MTH1, A Phase I, Study on Tumors Inhibition, First in Human, First in Class	NCT03036228	Cancer	Karonudib	18 Years - 75 Years	Thomas Helleday Foundation
A Study in Leukemia Patients With Karonudib	NCT04077307	Leukemia	Karonudib	18 Years - 75 Years	Thomas Helleday Foundation
MTH1, A Phase I, Study on Tumors Inhibition, First in Human, First in Class	NCT03036228	Cancer	Karonudib	18 Years - 75 Years	Thomas Helleday Foundation

Spots Global Cancer Trial Database for karonudib

Every month we try and update this database with for karonudib cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for karonudib

Every month we try and update this database with for karonudib cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for karonudib cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.