AS-1763 in Patients With Previously Treated CLL/SLL or Non-Hodgkin Lymphoma

Part of paid clinical trials in Orange, California.

Sponsor
Carna Biosciences, Inc.
Study ID
NCT05602363
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Docirbrutinib — DRUG
    oral tablet, twice daily

Study Details

This is an open-label, multi-center Phase 1b clinical study of oral AS-1763 (docirbrutinib) in patients with CLL/SLL or B-cell NHL who have failed or are intolerant to ≥2 lines of systemic therapy.

Key Dates

Start date
Aug 1, 2023
Status verified
Jul 2025
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation
    Dose escalation (3+3 design) and determination of MTD and DLTs CLL/SLL or B-cell NHL patients will self-administer docirbrutinib oral tablet at multiple dose levels twice daily for 24 cycles (1 cycle = 28 days).
  • Experimental: Dose Expansion
    Cohort 1: CLL/SLL patients, Cohort 2: B-cell NHL patients, Cohort 3: CLL/SLL or B-cell NHL patients with prior treatment with pirtobrutinib (Jaypirca) for an approved indication Patients will self-administer docirbrutinib oral tablet for 24 cycles (1 cycle = 28 days). Dose levels will be determined based on the result of dose escalation part.

Primary Outcome Measure

Number of patients with dose limiting toxicities (DLTs) and determination of maximum tolerated dose (MTD) [ Time Frame: Up to 24 cycles (1 cycle = 28 days) ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
UC Irvine HealthOrangeCalifornia92868
Catherine Coombs, MD
[email protected]
714-456-8000
Catherine Coombs, MD (PRINCIPAL_INVESTIGATOR)
Mount Sinai Comprehensive Cancer CenterMiami BeachFlorida33140
Yvonne Enriquez
[email protected]
305-674-2625
Jacqueline Barrientos, MD (PRINCIPAL_INVESTIGATOR)
Moffitt Cancer CenterTampaFlorida33612
Richard Corona
[email protected]
(813) 745-3465
Javier Pinilla-Ibarz, MD PhD (PRINCIPAL_INVESTIGATOR)
Northwestern Memorial HospitalChicagoIllinois60661
Study Cordinator
[email protected]
(312) 695 1301
Shuo Ma, MD PhD (PRINCIPAL_INVESTIGATOR)
American Oncology PartnersFort WayneIndiana46804
Phil Hutson
[email protected]
260-312-2219
Sunil Babu, MD (PRINCIPAL_INVESTIGATOR)
University of Maryland Medical Center - Greenebaum Comprehensive Cancer CenterBaltimoreMaryland21201
Nikki M Glynn-Cunningham, MS
[email protected]
410-328-7996
Seung Tae Lee, MD PhD (PRINCIPAL_INVESTIGATOR)
University of Massachusetts Memorial Medical CenterWorcesterMassachusetts01655
UMass Cancer Research Office
[email protected]
508-856-3216
Andrew J Gillis-Smith, MD (PRINCIPAL_INVESTIGATOR)
Optum Medical Care PCWestburyNew York11590
Jonathan Goldberg, MD
[email protected]
914-241-1050
Jonathan Goldberg, MD (PRINCIPAL_INVESTIGATOR)
Duke UniversityDurhamNorth Carolina27705
Terri Lucas
[email protected]
919-681-6580
Danielle Brander, MD (PRINCIPAL_INVESTIGATOR)
Taylor Cancer Research CenterMaumeeOhio43537
Nadine Nemunaitis
[email protected]
567-402-4501
John Nemunaitis, MD (PRINCIPAL_INVESTIGATOR)
Oncology ConsultantsHoustonTexas77030
Laura Guerra, RN, CCRC
[email protected]
713-516-4968
Marisol Dominguez
[email protected]
832-333-1480
Julio A Peguero, MD (PRINCIPAL_INVESTIGATOR)
University of Texas MD Anderson Cancer CenterHoustonTexas77030
Nitin Jain, MD
[email protected]
713-745-6080
Nitin Jain, MD (PRINCIPAL_INVESTIGATOR)
The Medical College of WisconsinMilwaukeeWisconsin53266
Medical College of Wisconsin Cancer Center Clinical Trials Office
[email protected]
414-805-8900
Nirav Shah, MD (PRINCIPAL_INVESTIGATOR)

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