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ABBV-901

Phase 1

Ovarian Cancer | Small molecule | Oncology |AbbVie Inc.|Last Updated: Jul 15, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment219

FDA Designations

No designations recorded

Clinical trial landscape

ABBV-901 · 1 trial · 1 indication

Phase 1 1
NCT07278336A Study to Assess Adverse Events, Change in Disease Activity and How Intravenous (IV) ABBV901 Moves Through the Body Alone or in Combination With Bevacizumab in Adult Participants With Ovarian CancerOvarian Cancer
RECRUITING219 Analytics
PHASE1RECRUITING
A Study to Assess Adverse Events, Change in Disease Activity and How Intravenous (IV) ABBV901 Moves Through the Body Alone or in Combination With Bevacizumab in Adult Participants With Ovarian Cancer
Ovarian CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants with Adverse Events (AE)
Up to Approximately 3 Years

An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have a causal relationship with this treatment.

Overall Response
Up to Approximately 3 Years

Overall response is defined as participants achieving confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as assessed by the investigator.

Secondary Endpoints

Duration of Response (DOR)
Up to Approximately 3 Years
Progression-free survival (PFS)
Up to Approximately 3 Years
Overall Survival (OS)
Up to Approximately 3 Years
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1: ABBV-901 Dose EscalationEXPERIMENTALParticipants will receive escalating doses of ABBV-901 alone, as part of the approximately 3 year study duration.
Part 2: ABBV-901 Optimization/Expansion Dose AEXPERIMENTALParticipants will receive ABBV-901 dose A alone, as part of the approximately 3 year study duration.
Part 2: ABBV-901 Optimization/Expansion Dose BEXPERIMENTALParticipants will receive ABBV-901 dose B alone, as part of the approximately 3 year study duration.
Part 2: ABBV-901 Optimization/Expansion Dose CEXPERIMENTALParticipants will receive ABBV-901 dose C alone, as part of the approximately 3 year study duration.
Part 3: ABBV-901 + Bevacizumab EscalationEXPERIMENTALParticipants will receive escalating doses of ABBV-901 in combination Bevacizumab, as part of the approximately 3 year study duration.
Part 4: ABBV-901 + Bevacizumab ExpansionEXPERIMENTALParticipants will receive the recommended doses for expansion doses of ABBV-901 in combination Bevacizumab, as part of the approximately 3 year study duration.

Interventions

NameTypeDescription
ABBV-901DRUGIntravenous (IV)
BevacizumabDRUGIV
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Eligibility Criteria

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

Inclusion Criteria: * Diagnosis of an advanced or unresectable malignant high grade serous epithelial ovarian, fallopian tube, and primary peritoneal cancers (EOC), fallopian tube or primary peritoneal cancer by histology (World Health Organization \[WHO\] criteria). * Participants must be consider...

Countries:United StatesChinaIsraelJapanNew ZealandTaiwan
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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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Recent Changes (Last 90 Days)

LOWJul 15, 2026NCT07278336lastUpdatePostDate: changed
LOWJul 15, 2026NCT07278336lastUpdatePostDate: changed
LOWJul 10, 2026NCT07278336lastUpdatePostDate: changed
LOWJul 10, 2026NCT07278336lastUpdatePostDate: changed
LOWJun 18, 2026NCT07278336Enrollment: 207 → 219
LOWJun 18, 2026NCT07278336Enrollment: 207 → 219
LOWJun 18, 2026NCT07278336Enrollment: 207 → 219

Frequently asked questions about ABBV-901

What is ABBV-901 used for in ovarian cancer?

ABBV-901 is an investigational small molecule being studied for the treatment of ovarian cancer. It is currently in Phase 1 clinical development, with an active trial assessing the drug alone or in combination with bevacizumab in adult participants with ovarian cancer. The drug is not yet approved and remains in clinical testing.

Who makes ABBV-901?

ABBV-901 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The company is currently conducting a Phase 1 clinical trial of ABBV-901 in ovarian cancer.

What phase is ABBV-901 in?

ABBV-901 is in Phase 1 clinical development. It is an investigational drug being studied for ovarian cancer and has not been approved by regulatory authorities. The ongoing Phase 1 trial is actively recruiting participants.

What clinical trials is ABBV-901 in?

ABBV-901 is being evaluated in a Phase 1 clinical trial with the identifier NCT07278336. This study assesses adverse events, changes in disease activity, and how intravenous ABBV-901 moves through the body, alone or in combination with bevacizumab, in adult participants with ovarian cancer. The trial is actively recruiting and has a target enrollment of 219 participants.

Is ABBV-901 being tested in combination with other drugs?

Yes, ABBV-901 is being studied both alone and in combination with bevacizumab in a Phase 1 clinical trial for ovarian cancer. The trial, NCT07278336, is designed to evaluate the safety and pharmacokinetics of ABBV-901 when given intravenously, either as a monotherapy or combined with bevacizumab.