CYT-0851 for Cancer

Recruiting in Palo Alto (17 mi)

+17 other 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.

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

I am not pregnant, breastfeeding, and have a recent negative pregnancy test.

I am fully active or can carry out light work.

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

My cancer is confirmed by lab tests and meets certain criteria.

My recent tests show positive biomarkers.

Exclusion Criteria

I have been diagnosed with HIV.

My high blood pressure is not under control.

I have a history of lung scarring or fibrosis.

I have ongoing lung inflammation.

I have severe nerve pain or damage.

I have active cancer spread to my brain or spinal cord.

My cancer has spread to the lining of my brain or spinal cord.

I have serious vision problems due to cataracts.

I had a bowel blockage treated medically within the last month.

I cannot eat two full meals a day or swallow pills.

I need fluid removed from my abdomen more often than every 4 weeks.

I have lost more than 10% of my weight in the last 3 months.

I have had a stem cell transplant from a donor.

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

I am taking medication that can affect my heart's rhythm.

I am on a daily steroid treatment not for cancer, equivalent to more than 10mg of Prednisone.

I cannot commit to all the study visits.

Participant Groups

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.

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