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AEZS-108

Phase 2

Ovarian Cancer | Small molecule | Oncology |COSCIENS Biopharma Inc.|Last Updated: Dec 13, 2011

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment85

FDA Designations

No designations recorded

Clinical trial landscape

AEZS-108 · 1 trial · 2 indications

Phase 2 1
NCT00569257Antitumoral Activity and Safety of AEZS-108 in Women With LHRH Receptor Positive Gynecological TumorsOvarian Cancer
COMPLETED85 Analytics
PHASE2COMPLETED
Antitumoral Activity and Safety of AEZS-108 in Women With LHRH Receptor Positive Gynecological Tumors
Ovarian CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Tumor response as per RECIST or (for Ovarian CA patients without evaluable target lesion following RECIST) GCIG criteria
up to six 3-weekly treatment cycles

Secondary Endpoints

Time-to-progression (TTP); Overall survival
up to observation of event
Safety of AEZS-108 (possibly drug-related adverse events)
4 weeks beyond last drug admnistration
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
AEZS-108DRUGintravenous infusion at a dose of 267 mg/sqm every 3 weeks, up to 6 treatment cycles
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites17

Inclusion Criteria: * LHRH receptor positive tumor status: positive receptor status determined by immunohistochemistry from primary tumor * Histologically confirmed epithelial ovarian cancer (Stratum A) * Advanced (FIGO III or IV) or recurrent disease * Progression during treatment with a platinum-...

Countries:BulgariaGermany
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Competitive Landscape -Ovarian Cancer 176 trials

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 AEZS-108

What is AEZS-108 used for?

AEZS-108 is an investigational small molecule being studied for the treatment of endometrial cancer and ovarian cancer. It is a targeted therapy that has been evaluated in clinical trials for these gynecological tumors. The drug is still in clinical development and is not approved by the FDA.

How does AEZS-108 work?

AEZS-108 targets LHRH receptors, which are found on certain gynecological tumors. By binding to these receptors, the drug is designed to deliver its anticancer effect specifically to cancer cells that express LHRH receptors. This targeted approach is being studied in patients with LHRH receptor positive tumors.

Who is developing AEZS-108?

AEZS-108 is being developed by COSCIENS Biopharma Inc., a biopharmaceutical company. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with gynecological cancers. COSCIENS Biopharma Inc. is publicly traded under the ticker symbol CSCI.

What phase is AEZS-108 in?

AEZS-108 has completed a Phase 2 clinical trial and a Phase 3 clinical trial. The Phase 2 trial evaluated the drug in women with LHRH receptor positive gynecological tumors, while the Phase 3 trial studied it as a second-line therapy for endometrial cancer. The drug is investigational and not yet approved.

What clinical trials is AEZS-108 in?

AEZS-108 has been studied in two completed clinical trials. The first, NCT00569257, was a Phase 2 trial in women with LHRH receptor positive ovarian and endometrial cancer. The second, NCT01767155, was a Phase 3 trial of zoptarelin doxorubicin (AEZS-108) as second-line therapy for endometrial cancer, enrolling 511 patients.

Is AEZS-108 the same as zoptarelin doxorubicin?

Yes, AEZS-108 is also known as zoptarelin doxorubicin. The Phase 3 clinical trial for endometrial cancer used the name zoptarelin doxorubicin (AEZS-108) to refer to the same drug. Both names refer to the same investigational compound being developed by COSCIENS Biopharma Inc.