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RECRUITING
NCT06582017
PHASE1

Safety, PK and Efficacy of QXL138AM in Patients With Solid Tumors and Multiple Myeloma

Sponsor: Nammi Therapeutics Inc

View on ClinicalTrials.gov

Summary

Study QXL138AM-001 is a Phase 1a/1b study to investigate the safety, pharmacokinetics, and preliminary activity of QXL138AM in subjects with locally advanced un-resectable and/or metastatic solid tumors and multiple myeloma. The study is an open-label, multicenter, first in human study to be conducted in two major parts which are further organized into two sub-parts. Part A Dose Escalation is a modified 3+3 with the first two cohorts consisting of one subject each based on the low clinical starting dose. Dose escalation in solid tumors (Part A1) will be followed by dose finding in multiple myeloma (Part A2). Part B consists of dose expansion in solid tumors (Part B1) and multiple myeloma (Part B2) using the recommended dose for expansion from Part A

Official title: A First-in-human Phase 1a/1b Study to Evaluate Safety and Tolerability of QXL138AM in Patients With Locally Advanced Un-resectable and/or Metastatic Solid Tumors and Multiple Myeloma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2024-08-28

Completion Date

2028-05-30

Last Updated

2024-09-03

Healthy Volunteers

No

Interventions

BIOLOGICAL

QXL138AM Injection every 2 weeks by IV Infusion

masked immuno-cytokine comprised of an anti-CD138 IgG1 antibody fused to human interferon alpha 2a

Locations (8)

University of Southern California

Los Angeles, California, United States

Cedars-Sanai Medical Center - Samuel Oschin Comprehensive Cancer

Los Angeles, California, United States

Hoag Memorial Hospital Presbyterian

Newport, California, United States

Sarah Cannon Research Institute - Denver DDU

Denver, Colorado, United States

Emory University - Winship Cancer Institute

Atlanta, Georgia, United States

New York Cancer & Blood Specialists

New York, New York, United States

University of Rochester - Wilmot Cancer Institute

Rochester, New York, United States

START San Antonio

San Antonio, Texas, United States