Study Evaluating ISM8207 in Participants With Advanced Solid Tumors and Relapsed/Refractory B-Cell Lymphoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorInSilico Medicine Hong Kong Limited
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
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.
Disqualifiers
Prior treated with other QPCTL, CD47 or SIRPα inhibitors.
Burkitt lymphoma/leukemia, plasma cell myeloma, plasmablastic lymphoma.
Participation in other therapeutic clinical studies within 28 days or 5 half- lives (whichever is shorter) prior to first dose of study treatment.
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.
Trial design
Design model
Sequential
Treatments tested in this trial
ISM8207
DrugPharmaceutical formulation: Capsules Mode of Administration: Oral
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Dose Escalation: ISM8207Experimental treatment 1 intervention
Group B: Dose Expansion: ISM8207Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of dose-limiting toxicity (DLT) events
Time frame
31 days2
Incidence and severity of adverse events (AEs)
Time frame
Approximately 2 years3
Recommended phase 2 dose (RP2D)
Time frame
31 daysSecondary outcomes
1
objective response rate (ORR)
Time frame
Approximately 2 years2
best objective response (BOR)
Time frame
Approximately 2 years3
duration of response (DoR)
Time frame
Approximately 2 years4
disease control rate (DCR)
Time frame
Approximately 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov