Evaluating ISM8207 for advanced solid tumors and B-cell lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Beijing Cancer Hospital
  Beijing, Beijing Municipality, China Recruiting
• The First Affiliated Hospital of Nanchang University
  Nanchang, Jiangxi, China Recruiting
• Shanghai Jiao Tong University School of Medicine-Ruijin Hospital
  Shanghai, Shanghai Municipality, China Recruiting
• Tianjin Medical University Cancer Institute&Hospital
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Study coordinator: Yichen Liu
• Email: Insilico-Clinicaltrial@insilico.ai
• Phone: 021-50831718

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.