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CPI-0209

Phase 1

Recurrent Ovarian Cancer | Small molecule | Oncology |Novartis AG|Last Updated: Jun 19, 2025

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

CPI-0209 · 1 trial · 1 indication

Phase 1 1
NCT05942300CPI-0209 Plus Carboplatin in Patients With Platinum Sensitive Recurrent Ovarian CancerRecurrent Ovarian Cancer
RECRUITING30 Analytics
PHASE1RECRUITING
CPI-0209 Plus Carboplatin in Patients With Platinum Sensitive Recurrent Ovarian Cancer
Recurrent Ovarian CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum tolerated dose (MTD) of CPI-0209
Up to 24 months

MTD will be determined via Dose-limiting toxicity (DLT)s defined as any grade 3-4 non-hematological or grade 4 hematological toxicity at least possibly related to the treatment, occurring during the first two cycles of treatment and per Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events (CTCAE) version 5.

Secondary Endpoints

Adverse Events by Grade per CTCAE v5.0
Up to 5.5 years
Overall Response Rate (ORR)
5.5 years
Progression-free Survival (PFS)
Up to 5.5 years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CPI-0209 (100 mg) + carboplatinEXPERIMENTALCPI-0209: 100 mg (oral dosing) carboplatin administered intravenously as per institutional standards
CPI-0209 (150 mg) + carboplatinEXPERIMENTALCPI-0209: 100 mg (oral dosing) carboplatin administered intravenously as per institutional standards

Interventions

NameTypeDescription
CPI-0209DRUGA second-generation EZH2 inhibitor that has been designed to achieve comprehensive anti-cancer target coverage through extended on-target residence time.
carboplatinDRUGCarboplatin is a chemotherapy drug that contains the metal platinum. It stops or slows the growth of cancer cells and other rapidly growing cells by damaging their DNA.
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patients with platinum-sensitive recurrent ovarian, fallopian or primary peritoneal cancer (defined as recurrent disease \> 6 months after completing last platinum- based chemotherapy) that are eligible to receive platinum-based chemotherapy). * Documented disease recurrence/p...

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

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 CPI-0209

What is CPI-0209 used for?

CPI-0209 is an investigational small molecule being studied for the treatment of recurrent ovarian cancer. It is currently in Phase 1 clinical development, specifically in combination with carboplatin for patients with platinum-sensitive recurrent ovarian cancer.

What does CPI-0209 target?

CPI-0209 is a small molecule in oncology development. Its specific molecular target has not been disclosed in the available clinical trial information. The ongoing trial is evaluating it in combination with carboplatin for recurrent ovarian cancer.

Who makes CPI-0209?

CPI-0209 is being developed by Novartis AG, a global pharmaceutical company listed on the New York Stock Exchange under the ticker NVS. The company is conducting a Phase 1 clinical trial of CPI-0209 in the United States.

What phase is CPI-0209 in?

CPI-0209 is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. The ongoing Phase 1 trial is recruiting patients with platinum-sensitive recurrent ovarian cancer in the United States.

What clinical trials is CPI-0209 in?

CPI-0209 is being studied in a single Phase 1 clinical trial with the identifier NCT05942300. The trial, titled 'CPI-0209 Plus Carboplatin in Patients With Platinum Sensitive Recurrent Ovarian Cancer,' is recruiting 30 female patients aged 18 years and older in the United States.