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Open Label LAM-003

Phase 1

Oncology | Small molecule | Oncology |IRulya Therapeutics Inc. Common Stock|Trials Updated: May 3, 2024

Open Label LAM-003 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Feb 2018

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment17

FDA Designations

No designations recorded

Open Label LAM-003 clinical trials

Open Label LAM-003 · 1 trial · 2 indications

Phase 1 1
NCT03426605A Study of LAM-003 in Patients With Acute Myeloid LeukemiaOncology
COMPLETED17 Analytics
PHASE1COMPLETED
A Study of LAM-003 in Patients With Acute Myeloid Leukemia
Oncology
NCT0342660517
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Study Endpoints

Primary Endpoints

Maximum Tolerated Dose (MTD)
At the end of the 28-day observation period for Cycle 1.

A primary objective was to determine the LAM-003 MTD and/or recommended dosing regimen (RDR) based on the pattern of dose-limiting toxicities (DLTs) in Cycle 1 of therapy. MTD as determined by DLTs.

Secondary Endpoints

Adverse Event Assessment
Weekly during the first 4 weeks and then every 4 weeks for up to 48 weeks.
Maximum Plasma Concentration (Cmax)
Cycle 1 Days 1, 2 and 8 (1 cycle = 28 days)
Time of Maximum Concentration [Tmax]
Cycle 1 Days 1, 2 and 8 (1 cycle = 28 days)
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
LAM-003EXPERIMENTALOpen label LAM-003 at three sequentially increasing starting dose levels of 200, 300 and 450 mg.

Interventions

NameTypeDescription
Open Label LAM-003DRUGLAM-003
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: 1. Men and women of age ≥18 years. 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. 3. Presence of measurable AML that has progressed during or relapsed after prior therapy 4. All acute toxic effects of any prior antitumor therapy resolved to Grade ...

Countries:United States
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