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Small Molecule Inhibitor

CYT-0851 for Cancer

Phase 1 & 2
Waitlist Available
Research Sponsored by Cyteir Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female ≥18 years of age at time of informed consent
Female subjects of childbearing potential must be non-lactating, not pregnant as confirmed by a negative serum pregnancy test at most 30 days before enrollment and within 72 hours before the first administration of CYT-0851
Timeline
Screening 3 weeks
Treatment Varies
Follow Up phase 1: 12 months
Awards & highlights

Study Summary

This trial is testing a new cancer drug to see if it is safe and works well.

Who is the study for?
Adults with certain B-cell malignancies or advanced solid tumors who understand the study and consent to participate. They must have a specific type of tumor, measurable disease, be in good physical condition (ECOG 0-1), and agree to use contraception if necessary. Excluded are those unable to swallow pills, recent heart attack or stroke victims, uncontrolled hypertension sufferers, individuals with active CNS metastases or significant health issues that could affect safety.Check my eligibility
What is being tested?
The trial is testing CYT-0851 alone and combined with other chemotherapy drugs like rituximab and bendamustine or gemcitabine in patients with relapsed/refractory B-cell malignancies and advanced solid tumors. The goal is to determine safe dosages for Phase 2 trials.See study design
What are the potential side effects?
Potential side effects may include typical reactions associated with chemotherapy such as nausea, fatigue, risk of infection due to lowered white blood cell counts, possible organ inflammation from drug interactions, and any unique adverse events related to CYT-0851 which will be closely monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am not pregnant, breastfeeding, and have a recent negative pregnancy test.
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I am a male who agrees to use contraception and not donate sperm during and for 90 days after the study.
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I am fully active or can carry out light work.
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My cancer is a type of B cell malignancy confirmed by testing.
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My cancer is confirmed by lab tests and meets certain criteria.
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I can and agree to have a biopsy, or I can provide a recent sample if needed.
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My recent tests show positive biomarkers.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~phase 1: 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and phase 1: 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part A: Incidence of dose limiting toxicity
Part B: Objective response rate
Part C: Incidence of dose limiting toxicity
+2 more
Secondary outcome measures
Part A: Assessment of pharmacokinetic parameters
Part A: Incidence of adverse events and other safety measures
Part A: Objective response rate
+15 more

Trial Design

5Treatment groups
Experimental Treatment
Group I: CYT-0851 dose expansionExperimental Treatment1 Intervention
Part B: CYT-0851 administered orally at the selected Phase 2 dose for 28 day cycles
Group II: CYT-0851 dose escalationExperimental Treatment1 Intervention
Part A: CYT-0851 administered orally in rising doses QD or BID for 28 day cycles
Group III: CYT-0851 and rituximab and bendamustineExperimental Treatment2 Interventions
Part C: Daily oral doses of CYT-0851 for 28 days in combination with rituximab on Day 1 and bendamustine on Days 1 and 2 of each 28 day cycle
Group IV: CYT-0851 and gemcitabineExperimental Treatment2 Interventions
Part D: Daily oral doses of CYT-0851 for 28 days in combination with gemcitabine on Day 1, 8 and 15 of each 28 day cycle
Group V: CYT-0851 and capecitabineExperimental Treatment2 Interventions
Part E: Daily oral doses of CYT-0851 for 21 days in combination with capecitabine on Days to 14 of each 21 day cycle

Find a Location

Who is running the clinical trial?

Cyteir Therapeutics, Inc.Lead Sponsor
Judson Englert, MDStudy DirectorCyteir Therapeutics
Markus Renschler, MDStudy DirectorCyteir Therapeutics
3 Previous Clinical Trials
454 Total Patients Enrolled

Media Library

CYT-0851 (Small Molecule Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03997968 — Phase 1 & 2
Chronic Lymphocytic Leukemia Research Study Groups: CYT-0851 dose escalation, CYT-0851 and capecitabine, CYT-0851 dose expansion, CYT-0851 and rituximab and bendamustine, CYT-0851 and gemcitabine
Chronic Lymphocytic Leukemia Clinical Trial 2023: CYT-0851 Highlights & Side Effects. Trial Name: NCT03997968 — Phase 1 & 2
CYT-0851 (Small Molecule Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03997968 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new patients being enrolled in this clinical trial?

"From what is published on clinicaltrials.gov, it appears that this particular trial is open and looking for volunteers. The listing was created on October 9th, 2019 with the most recent update being from August 24th, 2020."

Answered by AI

What are the primary health concerns that CYT-0851 has been shown to improve?

"CYT-0851 is an effective treatment for diffuse large B-cell lymphoma (DLBCL), hodgkin disease, and other b-cell lymphomas."

Answered by AI

What goals does this research hope to achieve?

"The purpose of this 24 month long experiment is to study the incidence of dose limiting toxicity. Additionally, data will be collected on laboratory and ECG abnormalities, duration of response, and objective response rate."

Answered by AI

How many different places are conducting this research currently?

"There are 18 locations in total where this trial is recruiting patients, these include the University of Michigan in Ann Arbor, Michigan, John Theurer Cancer Center at HUMC in Hackensack, New jersey and Oklahoma University-Stephenson Cancer Center in Oklahoma City, Oklahoma."

Answered by AI

How many individuals are currently taking part in this research project?

"A total of 320 individuals are required for this clinical trial, and these participants must meet the pre-specified inclusion criteria. The trial locations include University of Michigan in Ann Arbor, Michigan and John Theurer Cancer Center at HUMC in Hackensack, New jersey."

Answered by AI

Is this the first time CYT-0851 is being trialed?

"CYT-0851 was first studied at National Institutes of Health Clinical Center in 1993. There have been 874 completed studies thus far, with 460 clinical trials still active. A large number of these trials are based out Ann Arbor, Michigan."

Answered by AI

Who else is applying?

What site did they apply to?
Mayo Clinic
What portion of applicants met pre-screening criteria?
Did not meet criteria
~12 spots leftby Jul 2024