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A Phase 1/2 Study of CYT-0851 in B-Cell Malignancies and Advanced Solid Tumors

NCT03997968 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 169

Last updated 2024-12-24

No results posted yet for this study

Summary

This clinical trial is an interventional, active-treatment, open-label, multi-center, Phase 1/2 study. The study objectives are to assess the safety, tolerability and pharmacokinetics (PK) of CYT-0851 in patients with relapsed/refractory B-cell malignancies and advanced solid tumors and to identify a recommended Phase 2 dose as a monotherapy and in combination with chemotherapy for evaluation in these patients.

Conditions

Interventions

DRUG

CYT-0851

Part A and B: Daily oral doses of CYT-0851 for 28 day cycles

DRUG

CYT-0851 in combination with gemcitabine

Part D: Daily oral doses of CYT-0851 for 28 days in combination with gemcitabine

DRUG

CYT-0851 in combination with capecitabine

Part E: Daily oral doses of CYT-0851 for 21 days in combination with capecitabine

DRUG

CYT-0851 in combination with rituximab and bendamustine

Part C: Daily oral doses of CYT-0851 for 28 days in combination with rituximab and bendamustine

Sponsors & Collaborators

  • Cyteir Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Markus Renschler, MD · Cyteir Therapeutics

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-09
Primary Completion
2024-11-30
Completion
2024-12-20
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03997968 on ClinicalTrials.gov