Safety and Pharmacokinetics of NM6603 in Chinese Patients With Advanced Solid Tumors
ConditionCancers
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNucMito Pharmaceuticals Co. Ltd.
About this trial
This study is to assess the MTD and PK of NM6603 in adult patients with advanced solid tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Advanced solid tumors (primarily advanced colorectal cancer or triple-negative breast cancer) confirmed by histology or cytology
Prior adequate standard therapy with documented progression or intolerance, or lack of available standard therapy options, or contraindications to standard therapy
At least one evaluable tumor lesion per RECIST version 1.1
Age 18 to 75 years at the time of informed consent
Disqualifiers
Known hypersensitivity to NM6603 or its components
Prior treatment with a drug targeting the same mechanism of action or molecular target
Participation in another drug or device clinical trial within 4 weeks before first dose
Major surgery within 4 weeks before first dose or planned surgery during the study
Trial design
Design model
Sequential
Treatments tested in this trial
NM6603
DrugNM6603 is an orally administered investigational small-molecule drug evaluated in this dose-escalation study in patients with advanced solid tumors.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Dose EscalationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
maximum tolerated dose (MTD)
MTD was defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients. DLT will be defined as toxicities that meet pre-defined severity criteria(according to the NCI CTCAE v5.0 toxicity assessment criteria), and assessed as having a suspected relationship to study drug that occurred within the first cycle(28 days) of treatment.
Time frame
During the first cycle. Each cycle is 28 days2
Recommended Phase II Dose
The recommended dosage for subsequent Phase II studies will be based on MTD (Maximum Tolerant Dose), pharmacokinetics, preliminary efficacy and safety data from the study
Time frame
Up to 1 YearSecondary outcomes
1
Maximum observed concentration (Cmax) of NM6603
To evaluate the maximum observed concentration (Cmax) of NM6603 in subjects with advanced solid tumors
Time frame
Up to 31 days2
Time of maximum observed concentration (Tmax) of NM6603
To evaluate the time of maximum observed concentration (Tmax) of NM6603 in subjects with advanced solid tumors
Time frame
Up to 31 days3
Terminal elimination half-life (t1/2) of NM6603
To evaluate the terminal elimination half-life (t1/2) of NM6603 in subjects with advanced solid tumors
Time frame
Up to 31 days4
Area under the curve from the time of dosing to the time of the last measurable concentration (AUClast) of NM6603
To evaluate the area under the curve from the time of dosing to the time of the last measurable concentration (AUClast) of NM6603 in subjects with advanced solid tumors
Time frame
Up to 31 daysSponsors and contacts
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Source ClinicalTrials.gov