Study Evaluating ISM8207 in Participants With Advanced Solid Tumors and Relapsed/Refractory B-Cell Lymphoma
A Phase 1, Open-label, Multicenter, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ISM8207 Monotherapy in Patients With Advanced Solid Tumors or Relapsed/Refractory B-Lymphoid Malignancies
1 other identifier
interventional
60
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2024
Typical duration for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 25, 2024
CompletedFirst Submitted
Initial submission to the registry
May 31, 2024
CompletedFirst Posted
Study publicly available on registry
June 6, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 28, 2027
June 7, 2024
May 1, 2024
2.6 years
May 31, 2024
June 5, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (22)
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
- +17 more secondary outcomes
Study Arms (2)
Dose Escalation: ISM8207
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants will receive ISM8207 orally once daily in repeated 28-day cycles.
Interventions
Pharmaceutical formulation: Capsules Mode of Administration: Oral
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- Previous allogeneic stem cell transplantation or autologous stem cell. transplantation within 3 months prior to first receiving study treatment.
- Unresolved toxicity of Grade \>1 attributed to any prior therapies (excluding alopecia).
- Received antitumor steroid therapy within 7 days prior to the first study treatment administration.
- A serious illness or medical condition(s)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Shanghai Jiao Tong University School of Medicine-Ruijin Hospital
Shanghai, Shanghai Municipality, 200025, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 31, 2024
First Posted
June 6, 2024
Study Start
April 25, 2024
Primary Completion (Estimated)
November 30, 2026
Study Completion (Estimated)
February 28, 2027
Last Updated
June 7, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share