Advanced Solid Tumors, Relapsed/Refractory B-cell Lymphoma
Conditions
Keywords
Advanced solid tumors, Relapsed/refractory B-cell lymphoma, Lymphoma, B-cell
Brief summary
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
Interventions
DRUGISM8207
Pharmaceutical formulation: Capsules Mode of Administration: Oral
Sponsors
InSilico Medicine Hong Kong Limited
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female participants with age ≥18 years at the time of signing the informed consent. 2. 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. 3. 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. 4. ECOG PS (Eastern Cooperative Oncology Group Performance Status)≤1. 5. Life expectancy of ≥12 weeks as judged by the investigator. 6. Adequate organ function as determined by medical assessment. 7. Capable of providing signed ICF and complying with the requirements and restrictions listed in the ICF and in this study protocol. 8. 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
1. Prior treated with other QPCTL, CD47 or SIRPα inhibitors. 2. Burkitt lymphoma/leukemia, plasma cell myeloma, plasmablastic lymphoma. 3. Participation in other therapeutic clinical studies within 28 days or 5 half- lives (whichever is shorter) prior to first dose of study treatment. 4. Anti-tumor therapy (chemotherapy, immunotherapy, targeted therapy, biologic therapy, or other anti-tumor therapy) within 28 days or 5 half-lives, whichever is shorter prior to first dose of study treatment. 5. Previous allogeneic stem cell transplantation or autologous stem cell. transplantation within 3 months prior to first receiving study treatment. 6. Unresolved toxicity of Grade \>1 attributed to any prior therapies (excluding alopecia). 7. Received antitumor steroid therapy within 7 days prior to the first study treatment administration. 8. A serious illness or medical condition(s)
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate (ORR) | Approximately 2 years |
| best objective response (BOR) | Approximately 2 years |
| duration of response (DoR) | 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 |
Countries
China
Contacts
CONTACTYichen Liu
CONTACTJuan Xu
Outcome results
None listed