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ABBV-155

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |AbbVie Inc.|Last Updated: Dec 10, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment168
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03595059A Study With ABBV-155 Alone and in Combination With Taxane Therapy in Adults With Relapsed and/or Refractory Solid TumorsPHASE1 COMPLETED 168 — — Jul 13, 2018Sep 12, 2025Dec 10, 202540 United States, Australia +8
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Study Endpoints
Primary Endpoints
MTD and/or RPTD of ABBV-155
Up to approximately 21 days after initial dose of study drug

The Maximum Tolerated Dose (MTD) and/or the Recommended Phase Two Dose (RPTD) of ABBV-155 will be determined during the dose escalation phase (Part 1).

Overall Response Rate (ORR)
Up to approximately 2 to 6 months

ORR is defined as the percentage of participants with documented best response partial response (PR) or better according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Secondary Endpoints
Number of Participants with Adverse Events (AE)
Up to approximately 12 months
Duration of Response (DOR)
Up to approximately 12 months
Rate of Complete Response (CR)
Up to approximately 2 to 6 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Escalation 1a: ABBV-155EXPERIMENTALParticipants will be administered ABBV-155 (various doses).
Escalation 1b: ABBV-155 + paclitaxel or docetaxelEXPERIMENTALParticipants will be administered ABBV-155 (various doses) in combination with paclitaxel or docetaxel .
Expansion 2a: ABBV-155 in SCLCEXPERIMENTALDescription: Participants with small cell lung cancer (SCLC) will administer ABBV-155 (at the recommended Phase 2 dose).
Expansion 2b: ABBV-155 + paclitaxel in Breast CancerEXPERIMENTALParticipants with breast cancer will be administered ABBV-155 (at the recommended Phase 2 dose identified for combination with paclitaxel in part 1b) in combination with paclitaxel.
Expansion 2b: ABBV-155 + docetaxel in NSCLCEXPERIMENTALParticipants with non-small cell lung cancer (NSCLC) will be administered ABBV-155 (at or near the recommended Phase 2 dose identified for combination with paclitaxel in part 1b) in combination with docetaxel.
Interventions
NameTypeDescription
ABBV-155DRUGIntravenous (IV) Infusion
PaclitaxelDRUGIntravenous (IV) Infusion
DocetaxelDRUGIntravenous (IV) Infusion
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites40

Inclusion Criteria: * Has a histologic or cytologic diagnosis of a malignant solid tumor. * Participants enrolled in Part 2a (monotherapy, dose expansion) must have small cell lung cancer (SCLC) diagnosis; participants enrolled to Part 2b (combination therapy, dose expansion) must have either NSCLC...

Countries:United StatesAustraliaCanadaIsraelJapanNetherlandsPuerto RicoSouth KoreaSpainTaiwan
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Competitive Landscape -Other Solid Tumors 9 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab, V503, GARDASIL
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
AstraZeneca PLCAZN1 — Trastuzumab deruxtecan
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