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CYT-0851 in Relapsed/Refractory B-Cell Malignancies and Advanced Solid Tumors
NCT03997968Phase 2
Key facts
- Status
- Completed
- Start
- Oct 2019
- Primary completion
- Nov 2024
- Countries
- 1
- Sponsor
- Cyteir Therapeutics
- Modality
- Small Molecules
- Drugs
- emzadirib
- Conditions
- B cell lymphomadiffuse large B-cell lymphoma (DLBCL)mantle cell lymphoma (MCL)follicular lymphoma (FL)chronic lymphocytic leukemia (CLL)
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Overview
Phase 2, open-label trial of emzadirib in B cell lymphoma, diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL) and 9 more (5 arms), sponsored by Cyteir Therapeutics. Primary endpoints: Incidence of Dose Limiting Toxicity at 21 Days and Objective Response Rate at 24 Weeks. Started Oct 2019; status: completed.
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Design
5 arms- Study design
- Non-randomizedOpen-label
Dose Escalation (Mono)
CYT-0851 QD or BID
Dose Expansion (Mono)
CYT-0851 at RP2D
Combo: Rituximab + Bendamustine
CYT-0851 + Rituximab (D1) + Bendamustine (D1,2)
Combo: Gemcitabine
CYT-0851 + Gemcitabine (D1, 8, 15)
Combo: Capecitabine
CYT-0851 + Capecitabine (D1-14 q21d)
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Who it enrols
Adult patients with relapsed/refractory B-cell malignancies or advanced solid tumors who have failed or are ineligible for standard therapies. Specific cohorts require prior platinum, PARP inhibitors, or specific number of prior lines (e.g., 2 for DLBCL, 3 for MM).
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Endpoints
Primary
Incidence of Dose Limiting Toxicity
Objective Response Rate
Secondary
Incidence of Adverse Events
Assessment of Pharmacokinetic Parameters
Objective Response Rate
Duration of Response
Progression-Free Survival
Disease Control Rate
Overall Survival
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