CYT-0851 for Cancer

Recruiting at 17 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Cyteir Therapeutics, Inc.

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called CYT-0851 in patients with certain types of cancer that have not responded to other treatments. The goal is to see if the drug is safe and understand how it works in the body.

Research Team

Markus Renschler, MD

Principal Investigator

Cyteir Therapeutics

Eligibility Criteria

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.

Inclusion Criteria

My cancer is a type of B cell malignancy confirmed by testing.

I can and agree to have a biopsy, or I can provide a recent sample if needed.

My recent tests show positive biomarkers.

Exclusion Criteria

I have not had a heart attack or stroke in the last 6 months.

I haven't had cancer treatment in the last 14 days.

I had hepatitis C but completed treatment and now have an undetectable viral load.

Treatment Details

Interventions

• Bendamustine (Alkylating agents)
• Capecitabine (Nucleoside Analog)
• CYT-0851 (Small Molecule Inhibitor)
• Gemcitabine (Nucleoside Analog)
• Rituximab (Monoclonal Antibodies)

Trial Overview 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.

Participant Groups

Group I: CYT-0851 dose expansion Experimental Treatment 1 Intervention

Part B: CYT-0851 administered orally at the selected Phase 2 dose for 28 day cycles

Group II: CYT-0851 dose escalation Experimental Treatment 1 Intervention

Part A: CYT-0851 administered orally in rising doses QD or BID for 28 day cycles

Group III: CYT-0851 and rituximab and bendamustine Experimental Treatment 2 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 gemcitabine Experimental Treatment 2 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 capecitabine Experimental Treatment 2 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

Who Is Running the Clinical Trial?

Cyteir Therapeutics, Inc.

Lead Sponsor

Trials

1

Recruited

170+