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Tests treatment safety and results for Ovarian Cancer
Official title Safety, PK and Efficacy of QXL138AM in Patients With Solid Tumors and Multiple Myeloma
ClinicalTrials.gov ID: NCT06582017
What this study is testing
What is QXL138AM Injection every 2 weeks by IV Infusion?
QXL138AM Injection every 2 weeks by IV Infusion is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for ovarian cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants with Solid Tumors
- Histopathologically confirmed diagnosis of an advanced, unresectable, or metastatic solid tumor (ovarian, pancreatic, urothelial, renal...
- Have progressed despite standard therapies, or for whom conventional therapy is not effective or tolerable, as judged by the Investigator. Patients...
- Participants with Multiple Myeloma
- Have progressed despite standard therapies, or for whom conventional therapy is not effective or tolerable, as judged by the Investigator.
You likely can't join if
- New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, a history of risk...
- The use of concomitant medications that may significantly prolong the QT/QTc interval.
- Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy.
- Known hypersensitivity to the investigational product or components (anti-CD138 IgG1 antibody, Interferon A2a and/or the formulation excipients...
- Female participant is lactating.
- Any other clinically significant comorbidities.
See the full eligibility criteria
- 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...
- 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...
- 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.
- 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...
- The use of concomitant medications that may significantly prolong the QT/QTc interval.
- Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy.
- Known hypersensitivity to the investigational product or components (anti-CD138 IgG1 antibody, Interferon A2a and/or the formulation excipients: histidine, sucrose, arginine, polysorbate 80).
- Female participant is lactating.
- Any other clinically significant comorbidities.
- Received prior anticancer therapy within 28 days or 5x the half-life (whichever is shorter) prior to the first dose of investigational product.
- Participants who received wide-field radiation therapy within 4 weeks prior to first dose of investigational product, (2 weeks for limited field radiation therapy)
- Major surgery within 30 days before first dose of investigational product
- Chronic use of systemic corticosteroids of more than 20 mg/day of prednisone or equivalent.
- Active, clinically significant liver disease such as Hepatitis B or C, autoimmune hepatitis, or cirrhosis (Child Hugh Stage B or C).
- Current or history of mood disorder such as major depression per DSM-5 within past two years not controlled with current therapy.
- Active autoimmune disorders not controlled with current therapy.
- Active endocrine disorders including hypothyroidism, hyperthyroidism, hypoglycemia, hyperglycemia, and diabetes mellitus not controlled with current therapy.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Newport, California, United States
- Denver, Colorado, United States
- Atlanta, Georgia, United States
- New York, New York, United States
- Rochester, New York, United States
- San Antonio, Texas, United States
- Milwaukee, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Newport, California, United States; Denver, Colorado, United States; Atlanta, Georgia, United States; New York, New York, United States; Rochester, New York, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.