A Study of BH-30236 in Relapsed/ Refractory Acute Myelogenous Leukemia and Higher Risk Myelodysplastic Syndrome

Part of paid clinical trials in Duarte, California.

Sponsor
BlossomHill Therapeutics
Study ID
NCT06501196
Phase
PHASE1
Status
Recruiting
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Conditions

  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myeloid, Acute
  • Myelodysplastic Syndromes
  • Preleukemia
  • Refractory Acute Myeloid Leukemia

Eligibility Criteria

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

Interventions

  • BH-30236 — DRUG
    BH-30236 will be provided as either a 5 mg, 15 mg or 30 mg tablet. Participants will take BH-30236 tablets orally depending on their dose level assignment.
  • Venetoclax — DRUG
    Venetoclax will be provided as 10 mg, 50 mg or 100 mg tablets. Participants will take venetoclax orally per label instructions.

Study Details

Study BH-30236-01 is a first-in-human (FIH), Phase 1/1b, open-label, dose escalation and expansion study in participants with relapsed/refractory acute myelogenous leukemia (R/R AML) or higher-risk myelodysplastic syndrome (HR-MDS). Phase 1, Part 1 Dose Escalation - Monotherapy will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of BH-30236 administered orally. Approximately 50 participants may be enrolled in Phase 1, Part 1 Dose Escalation - Monotherapy. Phase 1, Part 2 Dose Escalation - Combination with Venetoclax will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of BH-30236 administered as a combination therapy with venetoclax. Approximately 48 participants may be enrolled in Phase 1, Part 2 Dose Escalation - Combination with Venetoclax. Phase 1b (Dose Expansion) will follow Phase 1 to further understand the relationships among dose, exposure, toxicity, tolerability, and clinical activity. Up to 72 participants may be enrolled in Phase 1b of the study as a monotherapy or in combination with venetoclax.

Key Dates

Start date
Jun 19, 2024
Status verified
Sep 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
170 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation Cohort - Monotherapy
    BH-30236 Monotherapy for Dose Escalation
  • Experimental: Dose Escalation Cohort - Combination with Venetoclax
    BH-30236 in Combination with Venetoclax for Dose Escalation.
  • Experimental: Dose Expansion Cohort - Monotherapy
    BH-30236 based on Monotherapy dose escalation data.
  • Experimental: Dose Expansion Cohort - Combination with Venetoclax
    BH-30236 in Combination with Venetoclax based on Dose Escalation data

Primary Outcome Measure

Dose Escalation: Frequency of dose limiting toxicities (DLTs) [ Time Frame: Dose-limiting toxicities are collected during the first treatment cycle (28 days) ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010-
University of California Los AngelesLos AngelesCalifornia90095-
Stanford Cancer CenterPalo AltoCalifornia94304-
Sylvester Comprehensive Cancer CenterMiamiFlorida33136-
Moffitt Cancer CenterTampaFlorida33612-
Northwestern Medicine - Northwestern Memorial Hospital Galter PavilionChicagoIllinois60611-
Roswell Park Cancer InstituteBuffaloNew York14263-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Study Coordinator
The Ohio State University Wexner Medical Center - James Cancer HospColumbusOhio43210-
Sarah Cannon Research InstituteNashvilleTennessee37203
Study Coordinator
The University of Texas M.D. Anderson Cancer CenterHoustonTexas77030-
Fred Hutchinson Cancer CenterSeattleWashington98109-
University of Wisconsin Clinical Science CenterMadisonWisconsin53792-

Find similar trials in Duarte, CA

By condition
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By specialty
OncologyBlood cancer
By research site
City of Hope Medical Center· Duarte, CAUniversity of California Los Angeles· Los Angeles, CAStanford Cancer Center· Palo Alto, CASylvester Comprehensive Cancer Center· Miami, FLMoffitt Cancer Center· Tampa, FLNorthwestern Medicine - Northwestern Memorial Hospital Galter Pavilion· Chicago, IL

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