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NCT06501196 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Leukemia and Myelodysplastic Syndromes, sponsored by BlossomHill Therapeutics.

Recruiting
Registry status
Phase 1
Development phase
170
Enrollment target
13
Study locations

NCT06501196 is a Phase 1 study of Leukemia and Myelodysplastic Syndromes that is actively recruiting participants, run by BlossomHill Therapeutics. The registered enrollment target is 170 participants, below the 486-participant average among 233 other Leukemia trials with a reported enrollment target (65% lower). The trial reports 13 study locations across 9 states.

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The verdict

NCT06501196, a Phase 1 study of Leukemia and Myelodysplastic Syndromes, is actively recruiting participants, sponsored by BlossomHill Therapeutics.

RECRUITING
Registry status
Phase 1
Development phase
170 participants
Enrollment target
13
Study locations

Study Summary

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.

Conditions Studied

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

Interventions

  • DRUG Venetoclax
  • DRUG BH-30236

Study Locations (13)

California

  • City of Hope Medical Center - Duarte
  • University of California Los Angeles - Los Angeles
  • Stanford Cancer Center - Palo Alto

Florida

  • Sylvester Comprehensive Cancer Center - Miami
  • Moffitt Cancer Center - Tampa

New York

  • Roswell Park Cancer Institute - Buffalo
  • Memorial Sloan Kettering Cancer Center - New York

Illinois

  • Northwestern Medicine - Northwestern Memorial Hospital Galter Pavilion - Chicago

Ohio

  • The Ohio State University Wexner Medical Center - James Cancer Hosp - Columbus

Tennessee

  • Sarah Cannon Research Institute - Nashville

Texas

  • The University of Texas M.D. Anderson Cancer Center - Houston

Washington

  • Fred Hutchinson Cancer Center - Seattle

Trial Details

FieldValue
Enrollment Target 170 participants
Start Date 2024-06-19
Est. Completion 2027-06
Phase Phase 1

Sponsor

BlossomHill Therapeutics

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06501196

The ClinicalTrials.gov registry entry for NCT06501196 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 170 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 486-participant average among 233 other Leukemia trials with a reported enrollment target (65% lower). The listed sponsor is BlossomHill Therapeutics, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 6 conditions, with Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Venetoclax is the first listed.

NCT06501196 reports 13 study locations spanning 9 distinct geographic areas - top geographies include California, Florida, New York.

Frequently Asked Questions

What is clinical trial NCT06501196 about?

NCT06501196 is a clinical study titled "A Study of BH-30236 in Relapsed/ Refractory Acute Myelogenous Leukemia and Higher Risk Myelodysplastic Syndrome". 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 sa...

What is the current status of trial NCT06501196?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 170 participants. The study started on 2024-06-19. Estimated completion is 2027-06.

What conditions does trial NCT06501196 study?

This clinical trial studies the following conditions: Leukemia, Myelodysplastic Syndromes, Refractory Acute Myeloid Leukemia, Leukemia, Myeloid, Acute, Leukemia, Myeloid.

What interventions are being tested in trial NCT06501196?

The interventions under investigation include: Venetoclax (DRUG), BH-30236 (DRUG).

Who is sponsoring clinical trial NCT06501196?

This trial is sponsored by BlossomHill Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06501196 being conducted?

This trial has 13 study locations across California, Florida, Illinois, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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