RecruitingPhase 1

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests QXL138AM in adults with advanced solid cancers or multiple myeloma, a cancer of blood-forming cells. It checks safety, how the body handles the drug, and early signs that it works. This is the first study of this drug in people and will help find a dose for further 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. 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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older.
  • For solid cancers: have a tissue-confirmed cancer that is advanced, cannot be removed by surgery, or has spread. Allowed cancers include ovarian, pancreatic, bladder or urinary tract, kidney, liver, digestive tract, lung, prostate, and breast cancer.
  • For solid cancers: standard treatments have failed, do not work, or cannot be tolerated, and no treatment known to help is available.
  • For multiple myeloma: standard treatments have failed, do not work, or cannot be tolerated. At least 3 prior treatments must have failed, with past use of a proteasome inhibitor, an IMiD, and an anti-CD38 drug—three types of myeloma treatment.
  • Be able to care for yourself and be out of bed for at least half the day. Have cancer that can be measured or checked using the study’s rules.
  • Have enough organ, heart, and bone marrow function. Bone marrow makes blood cells.
  • Women who can become pregnant must have negative pregnancy tests before treatment and use highly effective birth control during the study and for 120 days after the last dose.
  • Men who can father a child must use highly effective birth control during the study and for 120 days after the last dose. They must not donate sperm from before the first dose through 120 days after the last dose.

Who can't join

  • Certain serious heart problems, a heart attack in the past 6 months, unstable heartbeat, or risks for a dangerous heart rhythm. Past heart artery procedures or bypass surgery, abnormal heart test results, or drugs that affect heart rhythm may also rule you out.
  • An active, uncontrolled infection needing treatment that works throughout the body; an allergy to QXL138AM or its ingredients; or another major health condition.
  • Breastfeeding.
  • Recent cancer treatment: within 28 days or 5 times the time it takes half the drug to leave the body, whichever is shorter. Radiation within 4 weeks for a large area or 2 weeks for a small area also rules you out.
  • Major surgery within 30 days before the first dose, or ongoing steroid treatment above 20 mg of prednisone a day or an equal dose of another steroid.
  • Active, serious liver disease, such as hepatitis B or C, liver inflammation caused by the immune system, or moderate to severe liver scarring.
  • A mood disorder, such as major depression, now or within the past 2 years that is not controlled by current treatment.
  • An uncontrolled illness in which the immune system attacks the body, or an uncontrolled hormone condition, including thyroid problems, low or high blood sugar, or diabetes.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (10)

CA

CO

GA

NY

TX

WI

  • Froedtert Hospital & the Medical College of Wisconsin · Milwaukee, WI 53226Binod Dhakal, MD · Study contactMore trials in Milwaukee