A Study of an MMSET Inhibitor in Patients With Relapsed and Refractory Multiple Myeloma

Part of paid clinical trials in San Francisco, California.

Sponsor
K36 Therapeutics, Inc.
Study ID
NCT05651932
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Cohort A1 & A2: KTX-1001 — DRUG
    KTX-1001: Orally for 28 days each cycle until progression. Dexamethasone: Orally once weekly
  • Cohort B1 & B2: KTX-1001+Mezigdomide — DRUG
    Drug: KTX-1001: Orally for 28 days each cycle until progression Drug: Dexamethasone: Orally once weekly Drug: Mezigdomide Dexamethasone: Orally once weekly
  • Cohort C1 & C2: KTX-1001 + Carfilzomib (KYPROLIS®) — DRUG
    Drug: KTX-1001: Orally for 28 days each cycle until progression Drug: Dexamethasone: Orally once weekly Drug: Carfilzomib (KYPROLIS®): IV, once weekly for 3 weeks in each 28-day cycle
  • Cohort D: KTX-1001+ pomalidomide (Pomalyst, Imnovid) — DRUG
    Drug: KTX-1001: Orally for 28 days each cycle until progression Drug: Dexamethasone: Orally once a week Drug: Pomalidomide (Pomalyst, Imnovid): Orally, for 21 days in each 28-day cycle

Study Details

A Phase I study to evaluate the safety of a novel, orally available, selective, and potent small molecule inhibitor of the histone lysine methyl transferase MMSET (also known as NSD2/WHSC1) to prevent the dimethylation of H3K36 in adult patients with relapsed or refractory multiple myeloma (RRMM).

Key Dates

Start date
Feb 22, 2023
Status verified
Jun 2026
Primary completion
Dec 31, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
165 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A (Single agent): KTX-1001 + dexamethasone
    Cohort A1 (single agent): KTX-1001 at RP2D1 + dex Cohort A2 (single agent): KTX-1001 at RP2D2 + dex
  • Experimental: Cohort B (Mezigdomide): KTX-1001 + Mezigdomide + dex
    Cohort B1 (Mezigdomide): KTX-1001 at RP2D1 + Mezigdomide + dex Cohort B2 (Mezigdomide):: KTX-1001 at RP2D2 + Mezigdomide + dex
  • Experimental: Cohort C (carfilzomib/KYPROLIS®): KTX-1001 + carfilzomib + dex
    Cohort C1 (carfilzomib/KYPROLIS®): KTX-1001 at RP2D1 + carfilzomib + dex Cohort C2 (carfilzomib/KYPROLIS®): KTX-1001 at RP2D2 + carfilzomib + dex
  • Experimental: Cohort D (pomalidomide): KTX-1001 + pomalidomide + dex
    Cohort D (pomalidomide): KTX-1001 at RP2D2 + pomalidomide + dex

Primary Outcome Measure

Dose Escalation: Determination of Recommended Phase 2 Dose (RP2D) and/or Maximum Tolerated Dose (MTD) Dose Expansion: Provide preliminary efficacy data on the antitumor effects of KTX-1001 in combination with other anti-myeloma therapy [ Time Frame: Cycle 1 (28 days) ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
UCSF Medical Center - Hematology and Blood and Marrow Transplant ClinicSan FranciscoCalifornia94143
Phu Lam
[email protected]
415-858-7994
Alfred Chung, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic Hospital - FloridaJacksonvilleFlorida32224
Ahsan Rasheed
[email protected]
904-953-2000
Vivek Roy, MD (PRINCIPAL_INVESTIGATOR)
The Winship Cancer Institute of Emory UniversityAtlantaGeorgia30322
Geraldine Onwuzor
[email protected]
404-778-5144
Sagar Lonial, MD, FACP (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer InstituteBostonMassachusetts02215
Yuxin Liu, MD
[email protected]
Yuxin Liu, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114
Andrew Yee, MD
617-724-4000
Andrew Yee, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic - Transplant Center - RochesterRochesterMinnesota55905
Thomas Nelson
[email protected]
855-776-0015
David Dingli, MD, PhD (PRINCIPAL_INVESTIGATOR)
Hackensack University Medical CenterHackensackNew Jersey07601
Palka Anand
[email protected]
551-996-3040
David S Siegel, MD, PhD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10065
Mary Silverberg
[email protected]
Sharon Kim
[email protected]
Saad Usmani, MD, FACP (PRINCIPAL_INVESTIGATOR)
Atrium Health, Levine Cancer InstituteCharlotteNorth Carolina28204
Cindy Varga, MD (PRINCIPAL_INVESTIGATOR)
Duke University HospitalDurhamNorth Carolina27705
Jen Tichon
[email protected]
919-660-7262
Cristina Gasparetto, MD (PRINCIPAL_INVESTIGATOR)
University of PennsylvaniaPhiladelphiaPennsylvania19104
Sara Whittington
[email protected]
Ed Stadtmauer, MD (PRINCIPAL_INVESTIGATOR)
Tennessee OncologyNashvilleTennessee37203
Austin Windsor
[email protected]
629-278-3554
Jesus Berdeja, MD (PRINCIPAL_INVESTIGATOR)
University of Texas Southwestern Harold C. Simmons Comprehensive Cancer CenterDallasTexas75235
Aimaz Afrough, MD
[email protected]
833-722-6237
Aimaz Afrough, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in San Francisco, CA

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
UCSF Medical Center - Hematology and Blood and Marrow Transplant Clinic· San Francisco, CAMayo Clinic Hospital - Florida· Jacksonville, FLThe Winship Cancer Institute of Emory University· Atlanta, GADana-Farber Cancer Institute· Boston, MAMassachusetts General Hospital· Boston, MAMayo Clinic - Transplant Center - Rochester· Rochester, MN

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