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QXL138AM every 2 weeks by Infusion

Phase 1

Ovarian Cancer | Monoclonal antibody | Oncology |cbdMD, Inc.|Last Updated: Aug 27, 2026

Target and mechanism

ModalityMonoclonal antibody

Also known as QXL138AM Injection every 2 weeks by IV Infusion

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment100

FDA Designations

No designations recorded

Clinical trial landscape

QXL138AM every 2 weeks by Infusion · 1 trial · 9 indications

Phase 1 1
NCT06582017Safety, PK and Efficacy of QXL138AM in Patients With Solid Tumors and Multiple MyelomaOvarian Cancer
RECRUITING100 Analytics
PHASE1RECRUITING
Safety, PK and Efficacy of QXL138AM in Patients With Solid Tumors and Multiple Myeloma
Ovarian CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of Adverse Events
Throughout study - anticipated 3.5 years

Record all safety events during study including AEs, SAEs, DLTs, AESIs.

Secondary Endpoints

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
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Phase 1a Dose Escalation in Solid Tumors - Part A1EXPERIMENTALDose escalation of QXL138AM in participants with locally advanced un-resectable and/or metastatic solid tumors.
Phase 1a Dose Escalation in Multiple Myeloma - Part A2EXPERIMENTALDose escalation of QXL138AM in participants with multiple myeloma.
Phase 1b Dose Expansion in Solid Tumors - Part B1EXPERIMENTALDose expansion in solid tumors using the recommended dose for expansion from Part A1
Phase 1b Dose Expansion in Multiple Myeloma - Part B2EXPERIMENTALDose expansion in Multiple Myeloma using the recommended dose for expansion from Part A2

Interventions

NameTypeDescription
QXL138AM Injection every 2 weeks by IV InfusionBIOLOGICALmasked immuno-cytokine comprised of an anti-CD138 IgG1 antibody fused to human interferon alpha 2a
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites10

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 despit...

Countries:United States
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Competitive Landscape -Ovarian Cancer 175 trials

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AbbVie, Inc.ABBV13PHASE3Mirvetuximab soravtansine plus Bevacizumab, Bevacizumab
Bristol-Myers Squibb CompanyBMY4PHASE3Rucaparib, Nivolumab
Genmab A/S Sponsored ADRGMAB5PHASE3Rina-S, Paclitaxel, Topotecan, Pegylated liposomal doxorubicin, Gemcitabine
Pfizer Inc.PFE4PHASE3Avelumab, Lorlatanib, Talazoparib, Pemetrexed, Axitinib
Corcept Therapeutics Incorporated.CORT2PHASE3Nab-paclitaxel/m^2, Relacorilant once daily
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Imunon, Inc.IMNN3PHASE3IMNN-001, Paclitaxel, Carboplatin, Olaparib, Niraparib
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Regeneron Pharmaceuticals, Inc.REGN4PHASE2Ubamatamab, Bevacizumab, Cemiplimab, Fianlimab, PLD
Novartis AG Sponsored ADRNVS4PHASE2Dabrafenib, Trametinib
BeOne Medicines Ltd. Sponsored ADRONC2PHASE3Pamiparib
IQVIA Holdings IncIQV1PHASE3Oregovomab, Paclitaxel, Carboplatin
Xencor, Inc.XNCR3PHASE2vudalimab
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