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Monoclonal Antibodies

QXL138AM for Multiple Myeloma

Phase 1
Recruiting
Research Sponsored by Nammi Therapeutics Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female participants must be ≥18 years of age at the time of informed consent.
Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status scale of 0, 1, or 2 at Screening.
Must not have
Participants with current or history of mood disorder such as major depression per DSM-5 within the past two years not controlled with current therapy.
Participants with active autoimmune disorders not controlled with current therapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up throughout study - anticipated 3.5 years
Awards & highlights

Summary

"This trial is investigating the safety and effectiveness of QXL138AM in patients with advanced solid tumors and multiple myeloma. It will be conducted in two main parts, with the first part focusing on

Who is the study for?
This trial is for adults with advanced solid tumors or multiple myeloma that can't be removed by surgery or have spread. Participants must have measurable disease and acceptable organ function. They should not be receiving other cancer treatments, and they need to follow specific contraceptive guidelines.
What is being tested?
The study tests QXL138AM, a new drug given as an injection every two weeks. It's in early testing (Phase 1) to see how safe it is, how the body processes it, and if it works against various cancers including kidney, lung, liver, bladder, prostate, ovarian, gastrointestinal cancers and more.
What are the potential side effects?
Since this is a first-in-human study for QXL138AM, potential side effects are unknown but may include typical reactions related to IV infusions such as pain at the injection site, fever or chills. As treatment progresses more information on side effects will become available.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My mood disorder is not controlled despite treatment in the last 2 years.
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My autoimmune disorder is not under control despite treatment.
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I take more than 20 mg/day of prednisone or its equivalent.
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I am currently breastfeeding.
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My hormone-related conditions like thyroid issues or diabetes are not under control with my current treatment.
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I do not have severe heart issues or recent heart attacks.
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I do not have any active infections needing treatment.
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I am not allergic to the study drug or its ingredients.
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I haven't had cancer treatment within the last 28 days or 5 times the half-life of the last treatment, whichever is shorter.
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I do not have significant liver disease like Hepatitis B or C, autoimmune hepatitis, or severe cirrhosis.
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I have not had wide-field radiation in the last 4 weeks or limited field radiation in the last 2 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout study - anticipated 3.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout study - anticipated 3.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of Adverse Events
Secondary study objectives
Describe Anti-tumor activity
Incidence of Anti-drug Antibodies
Measurement of area under the serum concentration-time curve (AUC) of QXL138AM
+2 more
Other study objectives
Measurement of Exploratory Biomarkers

Trial Design

4Treatment groups
Experimental Treatment
Group I: Phase 1b Dose Expansion in Solid Tumors - Part B1Experimental Treatment1 Intervention
Dose expansion in solid tumors using the recommended dose for expansion from Part A1
Group II: Phase 1b Dose Expansion in Multiple Myeloma - Part B2Experimental Treatment1 Intervention
Dose expansion in Multiple Myeloma using the recommended dose for expansion from Part A2
Group III: Phase 1a Dose Escalation in Solid Tumors - Part A1Experimental Treatment1 Intervention
Dose escalation of QXL138AM in participants with locally advanced un-resectable and/or metastatic solid tumors.
Group IV: Phase 1a Dose Escalation in Multiple Myeloma - Part A2Experimental Treatment1 Intervention
Dose escalation of QXL138AM in participants with multiple myeloma.

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Who is running the clinical trial?

Nammi Therapeutics IncLead Sponsor
Dennis Kim, MDStudy DirectorNammi Therapeutics Inc
6 Previous Clinical Trials
911 Total Patients Enrolled
~67 spots leftby Dec 2027
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