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68Ga-FAP-2286

Phase 1

Solid Tumor | Small molecule | Oncology |Novartis AG|Last Updated: Apr 23, 2026

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 Enrollment222
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04939610A Study of 177Lu-FAP-2286 in Advanced Solid TumorsPHASE1 RECRUITING 222 — — Jul 30, 2021Jun 30, 2028Apr 23, 202640 United States, Australia +4
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Study Endpoints
Primary Endpoints
Phase 1: Dose-limiting toxicity (DLTs)
From first dose of study drug through at least 6-8 weeks after end of treatment (up to approximately 2 years)

To evaluate the safety and tolerability of \[177Lu\]Lu FAP 2286 and determine the RP2D

Phase 1: recommended Phase 2 dose (RP2D)
From first dose of study drug through at least 6-8 weeks after end of treatment (up to approximately 2 years)

To evaluate the safety and tolerability of \[177Lu\]Lu FAP 2286 and determine the RP2D

Phase 1: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) of [177Lu]Lu FAP 2286
From first dose of study drug through at least 6-8 weeks after end of treatment (up to approximately 2 years)

To evaluate the safety and tolerability of \[177Lu\]Lu FAP 2286 and determine the RP2D

Phase 2: Objective Response Rate (ORR)
From date of first [177Lu]Lu FAP 2286 treatment until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 59 months

Objective response is defined as a best confirmed response of CR or PR by RECIST v1.1 as assessed by the investigator. A confirmed CR or PR is a response that is maintained and documented on a subsequent tumor assessment no less than 28 days after the initial response. For Phase 2, ORR defined as the frequency and percentage of participants with a best confirmed response of CR or PR will be analyzed.

Phase 2: Dose-limiting toxicity (DLTs)
Assessed within 4 weeks of first Lu-FAP2286 treatment

To evaluate the safety and tolerability of \[177Lu\]Lu FAP 2286 and determine the RP2D in combination with mFOLFIRINOX in PDAC and the RP2D in combination with nab-paclitaxel in NSCLC (Phase 2 dose escalation for combination therapy)

Phase 2: recommended Phase 2 dose (RP2D)
From first dose of study drug through at least 6-8 weeks after end of treatment (up to approximately 2 years)

To evaluate the safety and tolerability of \[177Lu\]Lu FAP 2286 and determine the RP2D in combination with mFOLFIRINOX in PDAC and the RP2D in combination with nab-paclitaxel in NSCLC (Phase 2 dose escalation for combination therapy)

Phase 2: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) of [177Lu]Lu FAP 2286
From first dose of study drug through at least 6-8 weeks after end of treatment (up to approximately 2 years)

To evaluate the safety and tolerability of \[177Lu\]Lu FAP 2286 and determine the RP2D in combination with mFOLFIRINOX in PDAC and the RP2D in combination with nab-paclitaxel in NSCLC (Phase 2 dose escalation for combination therapy)

Secondary Endpoints
Phase 1: Absorbed dose (Gy) estimated in organs and tumor lesions
From first dose of study drug until disease progression or end of treatment (up to approximately 9 months)
Phase 1: Maximum standardized uptake value (SUVmax) in tumor lesions
Taken within 2 hours after 68Ga-FAP-2286 IV administration
Phase 1: Comparison of SUVmax in tumor lesions
From time of screening FDG PET/CT to 68Ga-FAP-2286 PET/CT (up to approximately 1 month)
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Phase 1: Dose EscalationEXPERIMENTALUp to 30 patients with solid tumors.
Phase 2: Specific Solid TumorsEXPERIMENTALUp to 192 participants treated with \[177Lu\]Lu-FAP-2286 in tumor-specific participant groups in monotherapy and in combination with chemotherapy.
Interventions
NameTypeDescription
68Ga-FAP-2286DRUG68Ga-FAP-2286 IV administered as imaging agent for PET scan.
177Lu-FAP-2286DRUGPhase 1: Patients with positive uptake of 68Ga-FAP- 2286 will receive a fixed dose of 177Lu-FAP-2286 IV administered every 6 weeks for a maximum of 6 doses. Doses range between 3.7 and 9.25 GBq (100-250 mCi). Phase 2: Monotherapy: Patients with positive uptake of 68Ga FAP 2286 will receive a fixed dose of 177Lu FAP 2286 IV administered at the RP2D determined in Phase 1 dose escalation in every 4 weeks. Combination therapy: Patients with positive uptake of 68Ga FAP 2286 will receive 177Lu-FAP-2286 based on dose escalation (starting with dose level 1) followed by dose expansion at selected dose.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites40

Inclusion Criteria: Eligible participants must meet the following inclusion criteria. The criteria below apply to participants enrolling in Phase 1 and Phase 2, unless otherwise specified. 1. Have signed and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved Info...

Countries:United StatesAustraliaCanadaFranceItalySpain
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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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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT04939610primaryCompletionDate: changed
LOWMay 24, 2026NCT04939610studyFirstPostDate: changed