New drug aims to supercharge immune system against tough cancers
NCT ID NCT06582017
First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 2 times
Summary
This early-stage trial tests a new drug called QXL138AM in about 100 people with advanced solid tumors (like ovarian, pancreatic, or lung cancer) or multiple myeloma. The drug is designed to help the immune system attack cancer cells. The main goal is to check safety and find the right dose, with a secondary look at whether it shrinks tumors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- QXL138AM (an antibody fused with an immune protein to target and attack cancer cells)
- What this could lead to
- If it works, this could point toward a new treatment option for several hard-to-treat cancers, including ovarian, pancreatic, and multiple myeloma.
- What could go wrong
- This is a very early, first-in-human trial with only 100 participants. The drug may not be safe or effective, and side effects could be serious. Success is far from guaranteed.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Aug 2024
- Expected to finish
-
May 2028
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Breast cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
10 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Cedars-Sanai Medical Center
RECRUITINGLos Angeles, California, 90048, United States
-
Cedars-Sanai Medical Center - Samuel Oschin Comprehensive Cancer
RECRUITINGLos Angeles, California, 90048, United States
-
Emory University - Winship Cancer Institute
RECRUITINGAtlanta, Georgia, 30322, United States
-
Froedtert Hospital & the Medical College of Wisconsin
RECRUITINGMilwaukee, Wisconsin, 53226, United States
-
Hoag Memorial Hospital Presbyterian
RECRUITINGNewport, California, 92663, United States
-
New York Cancer & Blood Specialists
RECRUITINGNew York, New York, 11967, United States
-
START San Antonio
RECRUITINGSan Antonio, Texas, 78229, United States
-
Sarah Cannon Research Institute - Denver DDU
RECRUITINGDenver, Colorado, 80218, United States
-
University of Rochester - Wilmot Cancer Institute
RECRUITINGRochester, New York, 14642, United States
-
University of Southern California
RECRUITINGLos Angeles, California, 90033, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a faster radiation course match the standard one after breast reconstruction?
- Bispecific antibody combo aims to deepen myeloma responses
- Can a stronger drug cocktail give older myeloma patients a better start?
- Radioactive missile aims at prostate cancer that spread
- Surgeons could freeze lung tumors from miles away using 5G robots
- Can High-Risk breast cancer patients skip an extra radiation boost?