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NCT Number: NCT06445517

Study Evaluating ISM8207 in Participants With Advanced Solid Tumors and Relapsed/Refractory B-Cell Lymphoma

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beijing Cancer Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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)

Treatment and study plan

ISM8207

Drug

Pharmaceutical formulation: Capsules Mode of Administration: Oral

Primary outcomes

  1. Incidence of dose-limiting toxicity (DLT) events

    Time frame: 31 days

  2. Incidence and severity of adverse events (AEs)

    Time frame: Approximately 2 years

  3. Recommended phase 2 dose (RP2D)

    Time frame: 31 days

Secondary outcomes

  1. objective response rate (ORR)

    Time frame: Approximately 2 years

  2. best objective response (BOR)

    Time frame: Approximately 2 years

  3. duration of response (DoR)

    Time frame: Approximately 2 years

  4. disease control rate (DCR)

    Time frame: Approximately 2 years

  5. progression-free survival (PFS)

    Time frame: Approximately 2 years

  6. 6-month overall survival (OS) rates

    Time frame: Approximately 2 years

  7. 1-year overall survival (OS) rates

    Time frame: Approximately 2 years

  8. maximum observed concentration (Cmax)

    Time frame: Approximately 2 years

  9. time of maximum observed concentration (Tmax)

    Time frame: Approximately 2 years

  10. area under the concentration-time curve (AUC)

    Time frame: Approximately 2 years

  11. terminal half-life (t1/2)

    Time frame: Approximately 2 years

  12. apparent clearance (CL/F)

    Time frame: Approximately 2 years

  13. apparent volume of distribution (Vz/F)

    Time frame: Approximately 2 years

  14. maximum observed concentration at steady state (Css,max)

    Time frame: Approximately 2 years

  15. minimum observed concentration at steady state (Css,min)

    Time frame: Approximately 2 years

  16. average concentration at steady state (Css,av)

    Time frame: Approximately 2 years

  17. time of Css,max (Tss,max)

    Time frame: Approximately 2 years

  18. AUC from time 0 to time dosing interval (AUCss,0-tau)

    Time frame: Approximately 2 years

  19. CLss/Fss

    Time frame: Approximately 2 years

  20. Vz/Fss

    Time frame: Approximately 2 years

  21. accumulation ratio of Cmax (RCmax) after multiple doses

    Time frame: Approximately 2 years

  22. accumulation ratio of AUC (RAUC) after multiple doses

    Time frame: Approximately 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

Juan Xu

CONTACT

[email protected]

Yichen Liu

CONTACT

[email protected]

021-50831718

Sponsors and collaborators

Lead sponsor

InSilico Medicine Hong Kong Limited

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jun 6, 2024
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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