A Phase 1 Study of SB1518 for the Treatment of Advanced Lymphoid Malignancies

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2011-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a Phase 1 dose escalation study to determine the maximum tolerated dose and the dose limiting toxicities of SB1518 when given alone once daily by mouth to subjects with advanced lymphoid malignancies.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Safety and Efficacy Study of SB1518 for the Treatment of Advanced Lymphoid Malignancies

NCT01263899

Hodgkin Lymphoma Mantle Cell Lymphoma Indolent Lymphoma

COMPLETED PHASE2

A Safety and Efficacy Study of HCB101, Fc-fusion Protein Targeting SIRPα-CD47 Pathway, in Solid or Hematological Tumors

NCT05892718

Advanced Solid Tumor Refractory Non-Hodgkin Lymphoma

RECRUITING PHASE1

An Engineered Sirpα Fused to Anti-Pd-L1 And Tgf-β Fusion Protein (HCB301) in Subjects With Selected Advanced Tumors

NCT06487624

Advanced Solid Tumor Refractory Hodgkin Lymphoma

RECRUITING PHASE1

SB-715992 in Treating Patients With Metastatic or Unresectable Solid Tumors or Hodgkin's or Non-Hodgkin's Lymphoma

NCT00101244

Adult Grade III Lymphomatoid Granulomatosis Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue Nodal Marginal Zone B-cell Lymphoma +30 more

TERMINATED PHASE1

Study of the Safety and Tolerability of PCI-24781 in Patients With Lymphoma

NCT00724984

Lymphoma Hodgkin Disease Lymphoma, Non-Hodgkin

COMPLETED PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lymphoma, Malignant Hodgkin's Lymphoma B Cell Lymphoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SB1518

SB1518 taken orally daily for 28 consecutive days in a 28 day cycle

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Exclusion Criteria

* Subject must have received at least 2 prior regimens for their lymphoid malignancy, one of which was an anthracycline-containing combination regimen and have shown disease relapse or did not respond to the prior regimen
* Subjects with classic HL or diffuse large B cell lymphoma must have failed, refused or are ineligible to receive stem cell transplant
* Subjects must have measurable lesions (at least one target lesion measuring 2cm in diameter) by computerized tomography (CT) scan
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* All men of reproductive potential and women of child-bearing potential must agree to practice effective contraception during the entire study period and for one month after the last study treatment unless documentation of infertility exists. Additionally, women of child-bearing potential must have a negative pregnancy test within 14 days prior to the first dose of study drug
* Able to understand and willing to sign the informed consent form

* Post-Transplant Lymphoproliferative Disease (PTLD), Burkitt's lymphoma, Burkitt-like lymphoma, lymphoblastic lymphoma/leukemia, multiple myeloma, or HIV-associated lymphoma
* History of or active Central Nervous System (CNS) malignancy
* Have undergone allogeneic stem cell transplant and were treated with immunosuppressing agent within the past 6 months
* Active Graft-versus-host disease (GVHD)
* Uncontrolled inter-current illness including, but not limited to, ongoing active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements as judged by treating physician. Subjects receiving antibiotics for infections that are under control may be included in the study
* Concurrent malignancy, except those subjects with early stage squamous cell carcinoma of the skin, basal cell carcinoma of the skin, or cervical intraepithelial neoplasia are eligible for the study
* Known HIV-positive (such subjects are at increased risk of lethal infections when treated with potentially marrow-suppressive therapy)
* Known active Hepatitis A, B or C
* Women who are pregnant or lactating

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No