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Trial Title:
Study Evaluating ISM8207 in Participants With Advanced Solid Tumors and Relapsed/Refractory B-Cell Lymphoma
NCT ID:
NCT06445517
Condition:
Advanced Solid Tumors
Relapsed/Refractory B-cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Conditions: Keywords:
Advanced solid tumors
Relapsed/refractory B-cell lymphoma
Lymphoma, B-cell
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ISM8207
Description:
Pharmaceutical formulation: Capsules Mode of Administration: Oral
Arm group label:
Dose Escalation: ISM8207
Arm group label:
Dose Expansion: ISM8207
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
Criteria for eligibility:
Criteria:
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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Facility:
Name:
Shanghai Jiao Tong University School of Medicine-Ruijin Hospital
Address:
City:
Shanghai
Zip:
200025
Country:
China
Status:
Recruiting
Start date:
April 25, 2024
Completion date:
February 28, 2027
Lead sponsor:
Agency:
InSilico Medicine Hong Kong Limited
Agency class:
Industry
Source:
InSilico Medicine Hong Kong Limited
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06445517
