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
1 other identifier
interventional
100
1 country
10
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 ovarian-cancer
Started Aug 2024
Typical duration for phase_1 ovarian-cancer
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 23, 2024
CompletedStudy Start
First participant enrolled
August 28, 2024
CompletedFirst Posted
Study publicly available on registry
September 3, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 30, 2028
April 13, 2026
April 1, 2026
3.3 years
August 23, 2024
April 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Adverse Events
Record all safety events during study including AEs, SAEs, DLTs, AESIs.
Throughout study - anticipated 3.5 years
Secondary Outcomes (5)
Measurement of maximum plasma concentration (Cmax) of QXL138AM
Throughout study - anticipated 3.5 years
Describe Anti-tumor activity
Part B of study - anticipated 1.5 years
Measurement of trough concentration (Ctrough) of QXL138AM
Throughout study - anticipated 3.5 years
Measurement of area under the serum concentration-time curve (AUC) of QXL138AM
Throughout study - anticipated 3.5 years
Incidence of Anti-drug Antibodies
Throughout study - anticipated 3.5 years
Other Outcomes (1)
Measurement of Exploratory Biomarkers
Throughout study - anticipated 3.5 years
Study Arms (4)
Phase 1a Dose Escalation in Solid Tumors - Part A1
EXPERIMENTALDose escalation of QXL138AM in participants with locally advanced un-resectable and/or metastatic solid tumors.
Phase 1a Dose Escalation in Multiple Myeloma - Part A2
EXPERIMENTALDose escalation of QXL138AM in participants with multiple myeloma.
Phase 1b Dose Expansion in Solid Tumors - Part B1
EXPERIMENTALDose expansion in solid tumors using the recommended dose for expansion from Part A1
Phase 1b Dose Expansion in Multiple Myeloma - Part B2
EXPERIMENTALDose expansion in Multiple Myeloma using the recommended dose for expansion from Part A2
Interventions
masked immuno-cytokine comprised of an anti-CD138 IgG1 antibody fused to human interferon alpha 2a
Eligibility Criteria
You may qualify if:
- 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.
- 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.
- \. 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.
- \. 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
University of Southern California
Los Angeles, California, 90033, United States
Cedars-Sanai Medical Center - Samuel Oschin Comprehensive Cancer
Los Angeles, California, 90048, United States
Cedars-Sanai Medical Center
Los Angeles, California, 90048, United States
Hoag Memorial Hospital Presbyterian
Newport, California, 92663, United States
Sarah Cannon Research Institute - Denver DDU
Denver, Colorado, 80218, United States
Emory University - Winship Cancer Institute
Atlanta, Georgia, 30322, United States
New York Cancer & Blood Specialists
New York, New York, 11967, United States
University of Rochester - Wilmot Cancer Institute
Rochester, New York, 14642, United States
START San Antonio
San Antonio, Texas, 78229, United States
Froedtert Hospital & the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dennis Kim, MD
Nammi Therapeutics Inc
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Masking Details
- Open-label
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 23, 2024
First Posted
September 3, 2024
Study Start
August 28, 2024
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
May 30, 2028
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share