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PSMA/PRAME

Phase 1

Ovarian | Monoclonal antibody | Oncology |MannKind Corporation|Last Updated: Aug 3, 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

PSMA/PRAME · 1 trial · 23 indications

Phase 1 1
NCT00423254Safety and Immune Response to a Multi-component Immune Based Therapy (MKC1106-PP) for Patients With Advanced Cancer.Ovarian
COMPLETED12 Analytics
PHASE1COMPLETED
Safety and Immune Response to a Multi-component Immune Based Therapy (MKC1106-PP) for Patients With Advanced Cancer.
OvarianUnlock trial analytics

Study Endpoints

Primary Endpoints

To determine the immunologic response to the treatment with MKC1106-PP regimen and 2) to determine the safety and adverse event profile of MKC1106-PP
Every 6 Weeks

Secondary Endpoints

to determine the blood plasmid levels by PCR analysis
Every 6 Weeks
measure cytokine levels
Every 6 Weeks
to describe any objective tumor responses to the treatment with MKC1106-PP
Every 6 Weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Low Dose CohortEXPERIMENTAL -
High Dose CohortEXPERIMENTAL -

Interventions

NameTypeDescription
PSMA/PRAMEBIOLOGICALLow dose
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: 18 years of age or older Advanced, refractory solid malignancy that is histologically proven Measurable disease ECOG performance status of 0, 1 or 2 Adequate bone marrow reserve as evidenced by a Absolute neutrophil count (ANC) = 1,500/microL; Platelet count = 100,000/microL Ade...

Countries:United States
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Competitive Landscape -Ovarian Cancer 176 trials (matched to "Ovarian")

Top 20 of 59 competitors

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK5PHASE3Pembrolizumab, Paclitaxel, Bevacizumab, Docetaxel
AstraZeneca PLCAZN19PHASE3Olaparib
GSK plc Sponsored ADRGSK4PHASE3Niraparib
Eli Lilly and CompanyLLY8PHASE3Sofetabart Mipitecan, Paclitaxel, Topotecan, Gemcitabine, Pegylated liposomal doxorubicin
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
Verastem, Inc.VSTM4PHASE3avutometinib, Defactinib, Pegylated liposomal doxorubicin, Paclitaxel, Letrozole
Zentalis Pharmaceuticals, Inc.ZNTL3PHASE3Azenosertib
Imunon, Inc.IMNN3PHASE3IMNN-001, Paclitaxel, Carboplatin, Olaparib, Niraparib
Incyte CorporationINCY2PHASE3INCB123667
Genelux Corp.GNLX1PHASE3olvimulogene nanivacirepvec, Platinum chemotherapy: carboplatin or cisplatin, Non-platinum chemotherapy: Physician's Choice of gemcitabine, taxane or pegylated liposomal doxorubicin, Bevacizumab
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
Exelixis, Inc.EXEL2PHASE2Cabozantinib
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Frequently asked questions about PSMA/PRAME

What is PSMA/PRAME used for in ovarian cancer?

PSMA/PRAME is an investigational monoclonal antibody being studied for the treatment of ovarian cancer. It is currently in Phase 1 clinical development. The drug is being evaluated for its safety and immune response in patients with advanced cancer, including ovarian cancer.

What does PSMA/PRAME target?

PSMA/PRAME is a monoclonal antibody that targets two antigens: PSMA (prostate-specific membrane antigen) and PRAME (preferentially expressed antigen in melanoma). These targets are associated with various cancer types, and the drug is designed to elicit an immune response against cells expressing these antigens.

Who makes PSMA/PRAME?

PSMA/PRAME is being developed by MannKind Corporation, a biopharmaceutical company. The company is listed on the stock exchange under the ticker symbol MNKD. The drug is currently in Phase 1 clinical trials for the treatment of ovarian cancer.

What phase is PSMA/PRAME in?

PSMA/PRAME is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The drug is being studied in a completed Phase 1 trial to evaluate its safety and immune response in patients with advanced cancer.

What clinical trials is PSMA/PRAME in?

PSMA/PRAME has one completed clinical trial, identified as NCT00423254. This Phase 1 study, titled "Safety and Immune Response to a Multi-component Immune Based Therapy (MKC1106-PP) for Patients With Advanced Cancer," enrolled 12 participants and included patients with ovarian cancer and other advanced solid tumors.

Is PSMA/PRAME the same as MKC1106-PP?

Yes, PSMA/PRAME is also known as MKC1106-PP. The completed Phase 1 clinical trial NCT00423254 evaluated MKC1106-PP, which is the same investigational therapy. This multi-component immune-based therapy is being developed by MannKind Corporation for advanced cancers, including ovarian cancer.