A Phase I Dose Escalation Study of the Safety and Pharmacokinetics of LAM-002A In Patients With Non-Hodgkin's Lymphoma

NCT02594384 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2024-08-22

Study results available
· View outcomes & findings →

Summary

This is a Phase 1 dose-exploration study of LAM-002A administered by mouth in patients with relapsed or refractory B-cell NHL. Safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD),and preliminary anti-tumor activity will be evaluated.

Conditions

  • Lymphoma, Non-Hodgkin; Leukemia, Chronic Lymphocytic

Interventions

DRUG

LAM-002A

25 mg capsules or 50 mg capsules

DRUG

Rituximab

375 mg/m2 by vein

DRUG

Atezolizumab

1200 mg by vein

Sponsors & Collaborators

  • OrphAI Therapeutics

    lead INDUSTRY

Principal Investigators

  • Langdon Miller, MD · AI Therapeutics

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2020-03-09
Completion
2023-03-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02594384 on ClinicalTrials.gov