Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06445517

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

Led by InSilico Medicine Hong Kong Limited · Updated on 2024-06-07

60

Participants Needed

2

Research Sites

148 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female participants aged 18 years or older
  • Histologically confirmed advanced or metastatic solid tumors with disease progression after standard therapy, intolerance to standard therapy, or no standard therapy available
  • Histologically confirmed B-cell lymphoma with at least one prior line of standard therapy and relapsed or refractory disease
  • Measurable or evaluable lesions according to RECIST or Lugano 2014 criteria
  • Eastern Cooperative Oncology Group Performance Status of 0 or 1
  • Life expectancy of at least 12 weeks as judged by the investigator
  • Adequate organ function based on medical assessment
  • Ability to provide signed informed consent and comply with study requirements
  • Agreement to use effective contraception during treatment and for 90 days after last dose for females of childbearing potential and males
Not Eligible

You will not qualify if you...

  • Prior treatment with QPCTL, CD47, or SIRPα inhibitors
  • Diagnosis of Burkitt lymphoma/leukemia, plasma cell myeloma, or plasmablastic lymphoma
  • Participation in other therapeutic clinical studies within 28 days or 5 half-lives prior to first study dose
  • Anti-tumor therapy within 28 days or 5 half-lives prior to first study dose
  • Allogeneic or autologous stem cell transplantation within 3 months prior to study treatment
  • Unresolved toxicity greater than Grade 1 from prior therapies (except alopecia)
  • Antitumor steroid therapy within 7 days prior to first study dose
  • Presence of serious illness or medical condition(s)

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Beijing Cancer Hospital

Beijing, Beijing Municipality, China, 100142

Actively Recruiting

2

Shanghai Jiao Tong University School of Medicine-Ruijin Hospital

Shanghai, Shanghai Municipality, China, 200025

Actively Recruiting

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Research Team

Y

Yichen Liu

CONTACT

J

Juan Xu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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