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
Not provided
The goal of this clinical trial is to study ISM8207 in participants with advanced solid tumors and relapsed/refractory B-cell lymphoma. The primary objective is to evaluate the safety and tolerability of ISM8207 orally administered in participants with advanced solid tumors and relapsed/refractory B-cell lymphoma
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation: ISM8207 | Experimental | Participants will receive ISM8207 orally once on day 1 during single dose period (3 days) then once daily in repeated 28-day cycles from Cycle 1 onwards. |
|
| Dose Expansion: ISM8207 | Experimental | Participants will receive ISM8207 orally once daily in repeated 28-day cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ISM8207 | Drug | Pharmaceutical formulation: Capsules Mode of Administration: Oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of dose-limiting toxicity (DLT) events | 31 days | |
| Incidence and severity of adverse events (AEs) | Approximately 2 years | |
| Recommended phase 2 dose (RP2D) | 31 days |
| Measure | Description | Time Frame |
|---|---|---|
| objective response rate (ORR) | Approximately 2 years | |
| best objective response (BOR) | Approximately 2 years | |
| duration of response (DoR) |
Not provided
Inclusion Criteria:
Male or female participants with age ≥18 years at the time of signing the informed consent.
Advanced solid tumors: Histologically confirmed advanced or metastatic solid tumors who have disease progression after standard therapy, intolerable to standard therapy, or for whom no standard therapy exists.
B-cell lymphoma: Histologically confirmed B-cell lymphoma who had received at least one prior line of standard therapy and were relapsed after or refractory to the standard therapy.
Have measurable or evaluable lesions in Part 1 and at least one measurable target lesion in Part 2 as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria or Lugano 2014.
ECOG PS (Eastern Cooperative Oncology Group Performance Status)≤1.
Life expectancy of ≥12 weeks as judged by the investigator.
Adequate organ function as determined by medical assessment.
Capable of providing signed ICF and complying with the requirements and restrictions listed in the ICF and in this study protocol.
Female subjects of childbearing potential and male subjects must agree to use an effective method of contraception during the treatment period and for 90 days after the last dose of ISM8207.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yichen Liu | Contact | 021-50831718 | Insilico-Clinicaltrial@insilico.ai | |
| Juan Xu | Contact | Insilico-Clinicaltrial@insilico.ai |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China | |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Approximately 2 years |
| disease control rate (DCR) | Approximately 2 years |
| progression-free survival (PFS) | Approximately 2 years |
| 6-month overall survival (OS) rates | Approximately 2 years |
| 1-year overall survival (OS) rates | Approximately 2 years |
| maximum observed concentration (Cmax) | Approximately 2 years |
| time of maximum observed concentration (Tmax) | Approximately 2 years |
| area under the concentration-time curve (AUC) | Approximately 2 years |
| terminal half-life (t1/2) | Approximately 2 years |
| apparent clearance (CL/F) | Approximately 2 years |
| apparent volume of distribution (Vz/F) | Approximately 2 years |
| maximum observed concentration at steady state (Css,max) | Approximately 2 years |
| minimum observed concentration at steady state (Css,min) | Approximately 2 years |
| average concentration at steady state (Css,av) | Approximately 2 years |
| time of Css,max (Tss,max) | Approximately 2 years |
| AUC from time 0 to time dosing interval (AUCss,0-tau) | Approximately 2 years |
| CLss/Fss | Approximately 2 years |
| Vz/Fss | Approximately 2 years |
| accumulation ratio of Cmax (RCmax) after multiple doses | Approximately 2 years |
| accumulation ratio of AUC (RAUC) after multiple doses | Approximately 2 years |
| Shanghai Jiao Tong University School of Medicine-Ruijin Hospital |
| Recruiting |
| Shanghai |
| Shanghai Municipality |
| 200025 |
| China |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |