ISM6331
DrugDosage form: Capsule for oral administration.
Frequency of administration: Once daily overall of treatment.
NCT Number: NCT06566079
This is a Phase 1, open-label, multicenter, FIH study to evaluate the safety, tolerability, recommended Phase 2 dose (RP2D), PK/PD, and preliminary anti-tumor activity of ISM6331 in participants with advanced or metastatic malignant mesothelioma or other solid tumors. The study consists of two parts, a dose escalation part (Part 1) and a dose selection optimization part (Part 2).
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1
Henan Cancer Hospital, Zhengzhou, Henan, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other protocol inclusion and exclusion criteria may apply.
Dosage form: Capsule for oral administration.
Frequency of administration: Once daily overall of treatment.
Time frame: Day 1 up to Day 31
DLT is defined as any adverse event which meets DLT criteria unless it is clearly related to disease progression or intercurrent illness during the first 31 days after the initiation of treatment in the dose escalation part (Part 1).
Time frame: Approximately 12 months.
Adverse events are assessed based on the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 [NCI CTCAE v5.0]
Time frame: Approximately 12 months.
Regular monitoring and assessment of vital signs (pulse rate, blood pressure, respiratory rate, and temperature), physical examinations, laboratory values, ECG, and other safety examinations by investigators.
Time frame: Approximately 40 months
The RP2D will be recommended by safety review committee (SRC) upon reviewing all available safety, tolerability, pharmacokinetics/pharmacodynamics, and preliminary efficacy data from Part 1 and Part 2.
Time frame: Approximately 12 months
Pharmacokinetics (PK) parameters of ISM6331 after dose of ISM6331 will be assessed.
Time frame: Approximately 12 months
Pharmacokinetics (PK) parameters of ISM6331 after dose of ISM6331 will be assessed.
Time frame: Approximately 12 months
Pharmacokinetics (PK) parameters of ISM6331 after dose of ISM6331 will be assessed.
Time frame: Approximately 12 months
Efficacy assessments will be conducted at baseline and every 8 weeks within the first 6 months after the first dose of study treatment, then every 12 weeks thereafter, until progressive disease confirmed by the investigator, start of a new anti-tumor treatment, death, lost to follow-up, or withdrawal from the study, whichever occurs first.
Time frame: Approximately 12 months
Efficacy assessments will be conducted at baseline and every 8 weeks within the first 6 months after the first dose of study treatment, then every 12 weeks thereafter, until progressive disease confirmed by the investigator, start of a new anti-tumor treatment, death, lost to follow-up, or withdrawal from the study, whichever occurs first.
Time frame: Approximately 12 months
Efficacy assessments will be conducted at baseline and every 8 weeks within the first 6 months after the first dose of study treatment, then every 12 weeks thereafter, until progressive disease confirmed by the investigator, start of a new anti-tumor treatment, death, lost to follow-up, or withdrawal from the study, whichever occurs first.
Contact information is provided by the study sponsor or research team.
InSilico Medicine Hong Kong Limited
Industry
A Phase 1, Open-Label, Multicenter, FIH Study to Evaluate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics, and Preliminary Efficacy of ISM6331 in Participants With Advanced/Metastatic Malignant Mesothelioma or Other Solid Tumors
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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