Ireland
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Recruiting Phase 1

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

NCT06582017 · tracked via the Priya Life Science USA tracker
Sponsor
Nammi Therapeutics Inc
Phase
Phase 1
Started
2024-08-28
Last updated
2026-10-20

Condition(s) studied

Ovarian CancerPancreas CancerUrothelial CarcinomaRenal Cell CarcinomaHepatocellular CarcinomaGastrointestinal CancerLung CancerProstate CancerBreast Cancer

Investigational drug(s) / intervention(s)

QXL138AM Injection every 2 weeks by IV Infusion

QXL138AM Injection every 2 weeks by IV Infusion: masked immuno-cytokine comprised of an anti-CD138 IgG1 antibody fused to human interferon alpha 2a

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Participants with Solid Tumors * Histopathologically confirmed diagnosis of an advanced, unresectable, or metastatic solid tumor (ovarian, pancreatic, urothelial, renal, hepatocellular, gastrointestinal (GI), lung, prostate, and breast cancer). * Have progressed despite standard therapies, or for whom conventional therapy is not effective or tolerable, as judged by the Investigator. Patients must have no available therapeutic options known to confer clinical benefit for their tumor type. 2. Participants with Multiple Myeloma * Have progressed despite standard therapies, or for whom conventional therapy is not effective or tolerable, as judged by the Investigator. * Patients must have failed at least 3 prior therapies for myeloma and should have had prior exposure to a proteosome inhibitor, an IMiD, and an anti-CD38-directed therapy. 2\. Male or female participants ≥18 years of age at the time of informed consent 3. An Eastern Cooperative Oncology Group (ECOG) performance status scale of 0, 1, or 2 at Screening 4. Must have at least 1 measurable lesion by RECIST version 1.1 (solid tumors only), or evaluable disease by IMWG Uniform Response Criteria (multiple myeloma only) 5. Adequate organ function and bone marrow reserve 6. Adequate cardiac function as estimated by left ventricular ejection fraction 7. Female participants of child-bearing potential must: * Have a negative serum pregnancy test at screening and a negative pregnancy test at Week 1 Day 1 prior to first dose of QXL138AM, AND * Agree to use at least 1 highly effective method of contraception for the duration of study participation, and for 120 days after last dose of QXL138AM. 8\. Male participants of child-bearing potential must: * Agree to use at least 1 highly effective method of contraception for the duration of study participation, and for 120 days after last dose of QXL138AM, AND * Refrain from sperm donation prior to the first dose of investigational product through 120 days following the last dose of QXL138AM. Exclusion Criteria: 1. New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, a history of risk factors for Torsades de Pointes (TdP), including heart failure, hypokalemia, and family history of long QTc syndrome, or evidence of ischemia on ECG. Symptomatic ischemic heart disease or unstable angina pectoris; or history of cardiac angioplasty, cardiac stenting, or coronary artery bypass graft. A clinically significant baseline prolongation of QT/QTcF interval at screening. 2. The use of concomitant medications that may significantly prolong the QT/QTc interval. 3. Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy. 4. Known hypersensitivity to the investigational product or components (anti-CD138 IgG1 antibody, Interferon A2a and/or the formulation excipients: histidine, sucrose, arginine, polysorbate 80). 5. Female participant is lactating. 6. Any other clinically significant comorbidities. 7. Received prior anticancer therapy within 28 days or 5x the half-life (whichever is shorter) prior to the first dose of investigational product. 8. Participants who received wide-field radiation therapy within 4 weeks prior to first dose of investigational product, (2 weeks for limited field radiation therapy) 9. Major surgery within 30 days before first dose of investigational product 10. Chronic use of systemic corticosteroids of more than 20 mg/day of prednisone or equivalent. 11. Active, clinically significant liver disease such as Hepatitis B or C, autoimmune hepatitis, or cirrhosis (Child Hugh Stage B or C). 12. Current or history of mood disorder such as major depression per DSM-5 within past two years not controlled with current therapy. 13. Active autoimmune disorders not controlled with current therapy. 14. Active endocrine disorders including hypothyroidism, hyperthyroidism, hypoglycemia, hyperglycemia, and diabetes mellitus not controlled with current therapy.

Primary outcome measure(s)

  • Incidence of Adverse Events — Throughout study - anticipated 3.5 years
    Record all safety events during study including AEs, SAEs, DLTs, AESIs.

Trial sites (11)

FacilityCityRegionStatus
University of Southern California Los Angeles California Recruiting
Cedars-Sanai Medical Center - Samuel Oschin Comprehensive Cancer Los Angeles California Recruiting
Cedars-Sanai Medical Center Los Angeles California Recruiting
Cedars-Sinai Medical Center - Samuel Oschin Comprehensive Cancer Institute Los Angeles California Recruiting
Hoag Memorial Hospital Presbyterian Newport California Recruiting
Sarah Cannon Research Institute - Denver DDU Denver Colorado Recruiting
Emory University - Winship Cancer Institute Atlanta Georgia Recruiting
New York Cancer & Blood Specialists New York New York Recruiting
University of Rochester - Wilmot Cancer Institute Rochester New York Recruiting
START San Antonio San Antonio Texas Recruiting
Froedtert Hospital & the Medical College of Wisconsin Milwaukee Wisconsin Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06582017 on ClinicalTrials.gov ↗ ← All trials in the USA