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Study Evaluating ISM8207 in Participants With Advanced Solid Tumors and Relapsed/Refractory B-Cell Lymphoma | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

NCT06445517•InSilico Medicine Hong Kong Limited

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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)

Locations (2)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Shanghai Jiao Tong University School of Medicine-Ruijin Hospital

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

April 25, 2024

Primary Completion Date

November 30, 2026

Completion Date

February 28, 2027

Last Updated

June 7, 2024

Enrollment

ESTIMATED participants

Conditions

Advanced Solid TumorsRelapsed/Refractory B-cell Lymphoma

Interventions

ISM8207

DRUG

Contacts

Yichen Liu

CONTACT

021-50831718 Insilico-Clinicaltrial@insilico.ai

Juan Xu

CONTACT

Insilico-Clinicaltrial@insilico.ai

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 7, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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