Evaluating ISM8207 for advanced solid tumors and 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
This study is testing a new oral medication called ISM8207 to see if it is safe and helps people with advanced solid tumors and B-cell lymphoma that haven't responded to other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | InSilico Medicine Hong Kong Limited Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 2 sites (Beijing, Beijing Municipality and 1 other locations) |
| Trial ID | NCT06445517 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and tolerability of ISM8207, an oral medication, in participants suffering from advanced solid tumors and relapsed or refractory B-cell lymphoma. The study includes participants who have experienced disease progression after standard therapies or have no available standard treatment options. It focuses on individuals with measurable lesions to assess the drug's effectiveness and safety profile. The trial is designed to gather critical data that could inform future treatment options for these challenging conditions.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with advanced solid tumors or relapsed/refractory B-cell lymphoma who have not responded to standard therapies.
Not a fit: Patients with early-stage tumors or those who have not yet undergone standard treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could provide a new treatment option for patients with advanced solid tumors and relapsed/refractory B-cell lymphoma.
How similar studies have performed: While this approach is being explored, similar studies have shown promise in targeting advanced cancers, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Beijing, Beijing Municipality and 1 other locations
- Beijing Cancer Hospital — Beijing, Beijing Municipality, China (Recruiting)
- Shanghai Jiao Tong University School of Medicine-Ruijin Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Yichen Liu
- Email: Insilico-Clinicaltrial@insilico.ai
- Phone: 021-50831718
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.