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LAM-003 for Acute Myeloid Leukemia

Phase 1
Waitlist Available
Research Sponsored by OrphAI Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cycle 1 days 1, 2 and 8 (1 cycle = 28 days)
Awards & highlights

Summary

A Phase 1 Dose-Escalation Study of LAM-003 in Patients with Acute Myeloid Leukemia

Eligible Conditions
  • Cancer
  • Acute Myeloid Leukemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cycle 1 days 1, 2 and 8 (1 cycle = 28 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and cycle 1 days 1, 2 and 8 (1 cycle = 28 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximum Tolerated Dose (MTD)
Secondary study objectives
Adverse Event Assessment
Area Under the Curve [AUC]
Event-Free Survival (EFS) and Overall Survival (OS)
+3 more

Side effects data

From 2020 Phase 1 trial • 17 Patients • NCT03426605
100%
Cough
67%
Chills
67%
Oedma peripheral
67%
Non-cardiac chest pain
67%
Vomiting
67%
Decreased appetitie
67%
Hypotension
67%
Febrile Neutropenia
67%
Pain in extremity
67%
Epistaxis
67%
Headache
67%
Dizziness
33%
Pyrexia
33%
Weight decreased
33%
Weight increased
33%
Skin erosion
33%
Swelling face
33%
Leukaemia cutis
33%
Stomatitis
33%
Neck pain
33%
Nasal ulcer
33%
Tumour lysis syndrome
33%
Diarrhoea
33%
Constipation
33%
Gingival bleeding
33%
Gastrooesophageal reflux disease
33%
Aspartate aminotransferase increased
33%
Blood calcium decreased
33%
Blood phosphorus decreased
33%
Arthralgia
33%
Hiccups
33%
Nasal congestion
33%
Palmar-plantar erythrodysaesthesia syndrome
33%
Urticaria
33%
Febrile neutropenia
33%
Procedural pain
33%
Tachycardia
33%
Confusional state
33%
Insomnia
33%
Dry eye
33%
Scrotal irritation
33%
Oropharyngeal pain
33%
Anal abcess
33%
Candida infection
33%
Nausea
33%
Abdominal pain
33%
Dysphagia
33%
Dyspnoea exertional
33%
Eyelid pain
33%
Blood magnesium decreased
33%
Blood sodium decreased
33%
Back pain
33%
Muscular weakness
33%
Musculoskeletal pain
33%
Plural effusion
33%
Haemoptysis
33%
Hypovolaemia
33%
Petechiae
33%
Dermatitis exfoliative
33%
Hypertension
33%
Disseminated intravascular coagulation
33%
Disease Progression
33%
Blood potassium decreased
33%
Alanine aminotransferase increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
LAM-003 300 mg QD
LAM-003 450 mg QD
LAM-003 600 mg QD
LAM-003 750 mg QD
LAM-003 200 mg QD

Trial Design

1Treatment groups
Experimental Treatment
Group I: LAM-003Experimental Treatment1 Intervention
Open label LAM-003 at three sequentially increasing starting dose levels of 200, 300 and 450 mg.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Open Label LAM-003
2018
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

OrphAI TherapeuticsLead Sponsor
6 Previous Clinical Trials
263 Total Patients Enrolled
AI Therapeutics, Inc.Lead Sponsor
6 Previous Clinical Trials
263 Total Patients Enrolled
Langdon Miller, M.D.Study DirectorAI Therapeutics
~2 spots leftby Sep 2025
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