Actively Recruiting
Safety, PK and Efficacy of QXL138AM in Patients With Solid Tumors and Multiple Myeloma
Led by Nammi Therapeutics Inc · Updated on 2026-04-13
100
Participants Needed
10
Research Sites
195 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Safety, PK and Efficacy of QXL138AM in Patients With Solid Tumors and Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older
- Histologically confirmed advanced, unresectable, or metastatic solid tumors (ovarian, pancreatic, urothelial, renal, hepatocellular, gastrointestinal, lung, prostate, breast cancer) who have progressed despite standard therapy or have no effective/tolerable treatments
- Patients with multiple myeloma who have progressed despite standard therapy and failed at least 3 prior therapies including a proteosome inhibitor, an IMiD, and anti-CD38 therapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- At least one measurable lesion by RECIST 1.1 for solid tumors or evaluable disease by IMWG criteria for multiple myeloma
- Adequate organ, bone marrow, and cardiac function
- Female participants of child-bearing potential must have negative pregnancy tests and agree to use effective contraception during and for 120 days after study participation
- Male participants of child-bearing potential must agree to effective contraception and refrain from sperm donation during and for 120 days after study participation
You will not qualify if you...
- New York Heart Association Class III or IV cardiac disease or recent myocardial infarction within 6 months
- Unstable arrhythmia or history of risk factors for Torsades de Pointes, or prolonged QT/QTc interval
- Use of medications that significantly prolong QT/QTc interval
- Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy
- Known hypersensitivity to QXL138AM components or excipients
- Female participants who are lactating
- Other clinically significant comorbidities
- Prior anticancer therapy within 28 days or 5 times the half-life before first dose
- Recent wide-field radiation therapy within 4 weeks or limited field radiation within 2 weeks
- Major surgery within 30 days before first dose
- Chronic systemic corticosteroid use exceeding 20 mg/day prednisone or equivalent
- Active significant liver disease such as Hepatitis B or C, autoimmune hepatitis, or cirrhosis (Child Hugh Stage B or C)
- Current or recent mood disorders such as major depression within 2 years not controlled with therapy
- Active autoimmune disorders not controlled with current therapy
- Active endocrine disorders including uncontrolled thyroid, blood sugar, or diabetes conditions
AI-Screening
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Trial Site Locations
Total: 10 locations
1
University of Southern California
Los Angeles, California, United States, 90033
Actively Recruiting
2
Cedars-Sanai Medical Center - Samuel Oschin Comprehensive Cancer
Los Angeles, California, United States, 90048
Actively Recruiting
3
Cedars-Sanai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
4
Hoag Memorial Hospital Presbyterian
Newport, California, United States, 92663
Actively Recruiting
5
Sarah Cannon Research Institute - Denver DDU
Denver, Colorado, United States, 80218
Actively Recruiting
6
Emory University - Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
7
New York Cancer & Blood Specialists
New York, New York, United States, 11967
Actively Recruiting
8
University of Rochester - Wilmot Cancer Institute
Rochester, New York, United States, 14642
Actively Recruiting
9
START San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
10
Froedtert Hospital & the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
D
David Stover, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
4
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