RecruitingPhase 1NCT06582017

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

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


Sponsor

Nammi Therapeutics Inc

Enrollment

100 participants

Start Date

Aug 28, 2024

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase trial tests the safety, dosing, and early effectiveness of a new drug called QXL138AM in people with advanced solid tumors (such as ovarian, lung, or pancreatic cancer) or multiple myeloma that has not responded to available treatments. **You may be eligible if...** - You have a confirmed advanced solid tumor (including ovarian, pancreatic, lung, kidney, liver, GI, prostate, or breast cancer) or multiple myeloma - Your cancer has progressed despite standard therapies, or no effective treatment exists for you - Your overall health and organ function meet the study requirements **You may NOT be eligible if...** - You have active brain metastases - You have had certain prior treatments that would overlap with this drug - You have serious heart problems or are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALQXL138AM Injection every 2 weeks by IV Infusion

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


Locations(10)

University of Southern California

Los Angeles, California, United States

Cedars-Sanai Medical Center - Samuel Oschin Comprehensive Cancer

Los Angeles, California, United States

Cedars-Sanai Medical Center

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

Froedtert Hospital & the Medical College of Wisconsin

Milwaukee, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT06582017


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