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Trial Title:
M1774 Human Mass Balance Study (DDRIVER Solid Tumors 303)
NCT ID:
NCT06308263
Condition:
Solid Tumor
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
Ataxia telangiectasia mutated and Rad3-related (ATR) inhibitor
ADME
Tuvusertib (M1774)
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
M1774 [14C]M1774 microtracer
Description:
Participants will receive single oral dose of M1774 containing a [14C]M1774 microtracer
solution on day 1 of period 1 under fasted conditions.
Arm group label:
Period 1: Mass Balance: M1774 + [14C]M1774 microtracer
Other name:
Tuvusertib
Intervention type:
Drug
Intervention name:
M1774
Description:
Participants will receive a single oral dose of M1774 on Day 1 of Period 1, and daily
single oral dose of M1774 for 2 weeks in 21 days cycle of Period 2.
Arm group label:
Period 1: Mass Balance: M1774 + [14C]M1774 microtracer
Arm group label:
Period 2: M1774
Other name:
Tuvusertib
Summary:
This is a single sequence 2-period open label study in participants with advanced solid
tumors. The purpose of Period 1 of this study is to assess the mass balance to determine
drug-related entities present in circulation and excreta and provide a comprehensive
understanding of biotransformation pathways and clearance mechanisms in participants with
advanced solid tumors. Thereafter, participants may enter an optional extension phase
(Period 2) where participants will receive M1774 until disease progression or other
criteria for study intervention discontinuation are met.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Are histologically proven advanced solid tumors that are considered appropriate for
treatment in Period 2 of this study, for which no effective standard therapy exists,
or standard therapy has failed or cannot be tolerated
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) less than or equal
to 1 (<=) 1
- Have evaluable disease according to Response Evaluation Criteria in Solid Tumors
(RECIST) 1.1 at Screening
- Are capable of giving signed informed consent, which includes compliance with the
requirements and restrictions listed in the informed consent form (ICF) and this
protocol
- Other protocol defined inclusion criteria could apply
Exclusion Criteria:
- Uncontrolled or poorly controlled arterial hypertension, symptomatic congestive
heart failure (New York Heart Association Classification more than equal to (>=)
Class III), uncontrolled cardiac arrhythmia, calculated Corrected QT interval (QTc)
average using the QT Interval Corrected Using Fridericia's Formula (QTcF) more than
(>) 480 msec; unstable angina pectoris, myocardial infarction, or a coronary
revascularization procedure, cerebral vascular accident, transient ischemic attack,
or any other significant vascular disease within 180 days of study intervention
start
- Presence of toxicities due to prior anticancer therapies (e.g. radiotherapy,
chemotherapy, immunotherapies, Et cetera (etc.)) that do not recover to (<=) Grade 1
with the exception of toxicities that do not pose a safety risk to the participant
in the judgment of the Investigator (e.g. ongoing Grade 2 alopecia)
- Treatment with live or live attenuated vaccine within 30 days of dosing
(non-replicating vector vaccines are permitted)
- Participation in a study involving administration of 14C-labeled compound(s) within
last 6 months prior to start of study intervention
- Other protocol defined exclusion criteria could apply
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Pharmaceutical Research Associates Magyarország Kutatás - Fejlesztési Kft., Klinikai Farmakológiai Vizsgálóhely
Address:
City:
Budapest
Country:
Hungary
Status:
Recruiting
Facility:
Name:
Észak Pesti Centrum Kórház-Honvédkórház, Onkológiai Osztály
Address:
City:
Budapest
Country:
Hungary
Status:
Recruiting
Start date:
March 25, 2024
Completion date:
November 26, 2025
Lead sponsor:
Agency:
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Agency class:
Industry
Source:
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06308263
https://clinicaltrials.emdgroup.com/en/trial-details/?idMS201924_0003
