Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 Dose Escalation | Experimental | Patients will receive ISM6331 once daily in sequential cohorts of increasing doses. |
|
| Part 2 Dose Selection Optimization | Experimental | Participants will receive ISM6331 once daily at each dose level from the two dose levels recommended by Study Review Committee. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ISM6331 | Drug | Dosage form: Capsule for oral administration. Frequency of administration: Once daily overall of treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of dose-limiting toxicity (DLT). | 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). | Day 1 up to Day 31 |
| Incidence and severity of adverse events (AEs) | Adverse events are assessed based on the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 [NCI CTCAE v5.0] | Approximately 12 months. |
| Incidence of clinically significant abnormalities in laboratory values, vital signs, physical examination, and electrocardiogram (ECG) measurements. | 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. | Approximately 12 months. |
| Recommended Phase 2 Dose (RP2D) | 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. | Approximately 40 months |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed concentration (Cmax) | Pharmacokinetics (PK) parameters of ISM6331 after dose of ISM6331 will be assessed. | Approximately 12 months |
| Area under the concentration-time curve (AUC) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other protocol inclusion and exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qinhan Chen | Contact | +86 021-50831718 | Insilico-Clinicaltrial@insilico.ai |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sarah Cannon Research Institute at HealthONE | Recruiting | Denver | Colorado | 80218 | United States | |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Pharmacokinetics (PK) parameters of ISM6331 after dose of ISM6331 will be assessed.
| Approximately 12 months |
| Terminal half-life (t1/2) | Pharmacokinetics (PK) parameters of ISM6331 after dose of ISM6331 will be assessed. | Approximately 12 months |
| Objective response rate (ORR). | 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. | Approximately 12 months |
| Best objective response (BOR). | 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. | Approximately 12 months |
| Duration of response (DoR). | 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. | Approximately 12 months |
| The University of Chicago Medical Center - Duchossois Center for Advanced Medicine |
| Recruiting |
| Chicago |
| Illinois |
| 60637 |
| United States |
| University Hospitals Cleveland Medical Center | Recruiting | Cleveland | Ohio | 44106 | United States |
| University of Pennsylvania - Abramson Cancer Center | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
| SCRI Oncology Partners | Recruiting | Nashville | Tennessee | 37203 | United States |
| NEXT Oncology - Austin | Recruiting | Austin | Texas | 78758 | United States |
| Henan Cancer Hospital | Recruiting | Zhengzhou | Henan | China |
| Shanghai Pulmonary Hospital | Not yet recruiting | Shanghai | Shanghai Municipality | China |
| Cancer Hospital Chinese Academy of Medical Sciences | Recruiting | Beijing | China |
| Sun Yat-Sen University Cancer Center | Recruiting | Guangzhou | China |
| ID | Term |
|---|---|
| D000086002 | Mesothelioma, Malignant |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D008654 | Mesothelioma |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018301 | Neoplasms, Mesothelial |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D010997 | Pleural Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided