Non Hodgkin Lymphoma Clinical Trial

Study of SGR-1505 in Mature B-Cell Neoplasms

Summary

The purpose of this study is to evaluate safety and tolerability and to determine the maximum tolerated dose (MTD) and/or recommended dose (RD) of SGR-1505.

View Full Description

Full Description

This is a study of SGR-1505 in subjects with relapsed/refractory (R/R) B-cell lymphomas to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), maximum tolerated dose (MTD) and/or recommended dose (RD) of SGR-1505. Exploratory cohorts will evaluate additional PK, PD, preliminary anti-tumor activity, and safety to establish the SGR-1505 RD. A sub-study will evaluate the effect of food and drug-drug interactions. A planned amendment will evaluate SGR-1505 in combination with other anti-cancer agents, such as BTK and BCL-2 inhibitors, in patients with specific B-cell malignancies.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Subject must have a history of histologically or cytologically confirmed mature B-cell malignancy.
Subject must have measurable or detectable disease according to the applicable disease-specific classification system.
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
Life expectancy ≥ 12 weeks.

Exclusion Criteria:

For a subject with indolent NHL and CLL/SLL, the subject is in need of immediate cytoreductive therapy (unless the patient has no remaining treatment choice with potential benefit) and has an indication for treatment.
Subject has previous invasive malignancy in the last 2 years.
Subject has a known allergy to SGR-1505 or excipients of SGR-1505.
Subject has symptomatic or active CNS involvement of disease.
Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding that would place the participant at increased risk to the use of an investigational drug.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

52

Study ID:

NCT05544019

Recruitment Status:

Recruiting

Sponsor:

Schrödinger, Inc.

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

Gabrail Cancer & Research Center
Canton Ohio, 44718, United States More Info
Carrie Smith, R.N.
Contact
330-492-3345
[email protected]
Nashat Gabrail, M.D.
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

52

Study ID:

NCT05544019

Recruitment Status:

Recruiting

Sponsor:


Schrödinger, Inc.

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.