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Ga-NeoB

Phase 1

Breast Cancer | Small molecule | Oncology |Novartis AG|Last Updated: Jun 8, 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
RandomizedCONTROLLEDBiomarker
Total Trials2
Total Enrollment106
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06247995A Phase I/II, Dose Finding and Optimization Study of [177Lu]Lu-NeoB in Combination With Capecitabine in Patients With GRPR+, ER+, HER2- Metastatic Breast Cancer After Progression on Previous Endocrine Therapy in Combination With a CDK4/6 Inhibitor.PHASE1 RECRUITING 58Aug 14, 2024Sep 9, 2031Jun 8, 202633 United States, Australia +11
NCT05870579[177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With ER+, HER2- and GRPR+ Advanced Breast CancerPHASE1 RECRUITING 48Nov 13, 2023Apr 5, 2032Jun 8, 202625 United States, China +5
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Study Endpoints
Primary Endpoints
Phase I: Incidence and severity of dose limiting toxicities (DLTs)
42 days after the first administration of [177Lu]Lu-NeoB

A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness/injury, or concomitant medications that occurs within the DLT period from C1D1 of treatment with \[177Lu\]Lu-NeoB and capecitabine. The National Cancer Institute (NCI) CTCAE version 5.0 will be used for all grading.

Phase I: Incidence and severity of adverse events and serious adverse events for 177-Lu-NeoB in combination with capecitabine
From start of study treatment until 56 days after the last dose of study treatment, assessed up to approximately 33 months

The distribution of adverse events for 177-Lu-NeoB in combination with capecitabine will be done via the analysis of frequencies for Adverse Event (AEs) and Serious Adverse Event (SAEs) through the monitoring of relevant clinical and laboratory safety parameters.

Phase I: Dose modifications for [177Lu]Lu-NeoB in combination with capecitabine
From start of study treatment until the last dose of study treatment, assessed up to approximately 31 months

Dose modifications (dose interruptions, dose discontinuations and reductions) for \[177Lu\]Lu-NeoB in combination with capecitabine will be assessed and summarized using descriptive statistics.

Phase II: Objective Response Rate (ORR)
From date of randomization until date of progression, death or further antineoplastic therapy, whichever comes first, assessed up to approximately 88 months

Objective Response Rate (ORR) with confirmed response is defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR), as per local review and according to RECIST 1.1.

Phase II: Clinical Benefit Rate (CBR)
From date of randomization until date of progression, death or further antineoplastic therapy, whichever comes first, assessed up to approximately 88 months

Clinical Benefit Rate (CBR) with confirmed response is defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR), or maintaining an overall response of Stable Disease (SD) for at least 24 weeks. CR, PR, and SD are defined as per local review according to RECIST 1.1.

Phase II: Time to Response (TTR)
From date of randomization until first documented evidence of CR or PR (the response prior to confirmation), assessed up to approximately 88 months

Time to response is the time from the date of randomization to the first documented response (Complete Response (CR) or Partial Response (PR), which must be confirmed subsequently) as per local review and according to RECIST 1.1.

Phase II: Duration of Response (DoR)
From first documented evidence of CR or PR (the response prior to confirmation) until time of documented disease progression or death due to any cause, whichever comes first, assessed up to approximately 88 months

Duration of Overall Response (DoR) applies only to participants whose best overall response is confirmed CR or confirmed PR according to RECIST 1.1. The start date is the date of first documented confirmed response (CR or PR) and the end date is the date defined as first documented progression or death due to underlying cancer.

Phase II: Progression Free Survival (PFS)
From the date of first dose to the date of confirmed progression or death due to any cause, whichever comes first, assessed up to approximately 88 months

Progression Free Survival (PFS) is defined as the time from the date of first dose of \[177Lu\]Lu-NeoB to the date of confirmed progression or death due to any cause. PFS will be assessed via local review according to RECIST 1.1.

Phase II: Overall Survival (OS)
From the date of first dose until date of death from any cause, assessed up to approximately 88 months

Overall Survival (OS) is defined as the time from date of first dose of \[177Lu\]Lu-NeoB to date of death due to any cause.

Incidence and nature of DLTs during the DLT observation period
28 days after the first administration of [177Lu]Lu-NeoB

A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness/injury, or concomitant medications that occurs within the DLT period from C1D1 of treatment with \[177Lu\]Lu-NeoB, ribociclib and fulvestrant with or without goserelin. The National Cancer Institute (NCI) CTCAE version 5.0 will be used for all grading.

Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
From date of enrollment till 8 weeks after end of Treatment, assessed up to approximately 60 months

The distribution of adverse events will be done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters.

Incidence of dose interruptions, discontinuation and dose reductions
From date of enrollment till 8 weeks after end of Treatment, assessed up to approximately 60 months

Dose interruptions, discontinuation and dose reductions will be assessed for tolerability.

Secondary Endpoints
Phase I and II: Time activity curves (TACs) related to [177Lu]Lu-NeoB
After First, Third and Fifth [177Lu]Lu-NeoB administrations: 1-4hrs, 24hrs, 48hrs and 168hrs after infusion.
Phase I and II: Absorbed radiation doses of [177Lu]Lu-NeoB in organs and target lesions
After First, Third and Fifth [177Lu]Lu-NeoB administrations: 1-4hrs, 24hrs, 48hrs and 168hrs after infusion.
Phase I and II: Concentration of [177Lu]Lu-NeoB in blood over time
First [177Lu]Lu-NeoB administration: Day 1 (Pre-dose (before start of infusion)), At end of infusion, 0.5, 1, 2, 4 and 6 hours post-dose/post-infusion (p.i.)), Day 2 (24 hours p.i), Day 3 (48 hours p.i), Day 8 (168 hours p.i)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Dose A: [177Lu]Lu-NeoB 150mCi q6w + capecitabineEXPERIMENTAL\[177Lu\]Lu-NeoB 150mCi q6w + Capecitabine 1000mg/ m2 BID Day1-14 in a 21-day schedule
Dose B: [177Lu]Lu-NeoB 100mCi q3w + capecitabineEXPERIMENTAL\[177Lu\]Lu-NeoB 100mCi q3w+ Capecitabine 1000mg/m2 BID Day1-14 in a 21-day schedule
Dose C: [177Lu]Lu-NeoB 200mCi q6w + capecitabineEXPERIMENTAL\[177Lu\]Lu-NeoB 200mCi q6w + Capecitabine 1000mg/m2 BID Day1-14 in a 21-day schedule
Dose D: [177Lu]Lu-NeoB 100mCi q6w + capecitabineEXPERIMENTAL\[177Lu\]Lu-NeoB 100mCi q6w + Capecitabine 1000mg/m2 BID Day1-14 in a 21-day schedule
Arm 1EXPERIMENTALParticipants will receive \[177Lu\]Lu- NeoB in combination with ribociclib and fulvestrant, in the dose escalation and the backfill parts of the study. Goserelin administration is only applicable for pre/peri-menopausal women and men.
Interventions
NameTypeDescription
[68Ga]Ga-NeoBDRUG68Ga\]Ga-NeoB serves as a radioactive imaging compound to be used for PET imaging for localization of GRPR positive lesions.
[177Lu]Lu-NeoBDRUG\[177Lu\]Lu-NeoB is a radioligand therapy drug.
CapecitabineDRUGCapecitabine is a chemotherapy drug.
RibociclibDRUG600 mg once daily (OD) days 1 to 21 every 28 days
FulvestrantDRUG500 mg at Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 and every 28 days thereafter
GoserelinOTHERFor pre/peri-menopausal women and men only.
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Eligibility Criteria
Age Range18 Years — 100 Years
SexALL
Healthy VolunteersNo
Study Sites33

Inclusion Criteria: 1. Signed informed consent must be obtained prior to participation in the study. 2. Participant is female or male adult ≥ 18 years old at the time of informed consent(s). 3. Participant has a histologically and/or cytologically documented diagnosis of ER+ breast cancer (ER expre...

Countries:United StatesAustraliaCanadaChinaFranceGermanyItalyNetherlandsPortugalSingaporeSouth KoreaSpainUnited KingdomPoland
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Competitive Landscape -Breast Cancer 408 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK12PHASE3Pembrolizumab, Paclitaxel, Doxorubicin, Epirubicin, Cyclophosphamide
AstraZeneca PLCAZN47PHASE3Fulvestrant, Capivasertib, Trastuzumab Deruxtecan, Paclitaxel, Trastuzumab
Gilead Sciences, Inc.GILD13PHASE3Sacituzumab Govitecan-hziy, Eribulin, Capecitabine Product, Gemcitabine, Vinorelbine
Eli Lilly and CompanyLLY27PHASE3Abemaciclib, Standard Adjuvant Endocrine Therapy, Imlunestrant, Tamoxifen, Anastrozole
BioNTech SE Sponsored ADRBNTX7PHASE3DB-1303/BNT323, T-DM1, Capecitabine, Paclitaxel, Nab-paclitaxel
Novartis AG Sponsored ADRNVS30PHASE3Ribociclib, Alpelisib, Fulvestrant, Trastuzumab, Pertuzumab
Olema Pharmaceuticals, Inc.OLMA5PHASE3Palazestrant, Fulvestrant, Anastrozole, Letrozole, Exemestane
Pfizer Inc.PFE34PHASE3ARV-471, Fulvestrant, PF-07220060, letrozole, abemaciclib
BeOne Medicines Ltd. Sponsored ADRONC6PHASE3BGB-43395, Letrozole, Abemaciclib, Palbociclib, Ribociclib
Jazz Pharmaceuticals Public Limited CompanyJAZZ3PHASE3Zanidatamab, Trastuzumab, Eribulin, Vinorelbine, Gemcitabine
Celcuity Inc.CELC3PHASE3Gedatolisib, Palbociclib, Fulvestrant, Alpelisib, Arm A: Gedatolisib + Palbociclib + Fulvestrant
Relay Therapeutics, Inc.RLAY2PHASE3RLY-2608, Capivasertib, Fulvestrant, Palbociclib, Ribociclib
GSK plc Sponsored ADRGSK2PHASE3Niraparib
Greenwich LifeSciences, Inc.GLSI1PHASE3GLSI-100
Bristol-Myers Squibb CompanyBMY5PHASE2Iza-bren, Nab-paclitaxel, Paclitaxel, Capecitabine, Carboplatin
BriaCell Therapeutics CorpBCTX2PHASE3SV-BR-1-GM, Cyclophosphamide, Interferon infiltration of the inoculation site, Retifanlimab, Treatment of Physician's Choice
Incyte CorporationINCY4PHASE2Ruxolitinib, Capecitabine, Regorafenib, Pembrolizumab, Axatilimab
Natera, Inc.NTRA3PHASE2Discontinuation of the anti-HER2 maintenance therapy
Puma Biotechnology, Inc.PBYI3PHASE2Neratinib, Loperamide, Colesevelam, Alisertib, Endocrine therapy
Immutep Ltd Sponsored ADRIMMP1PHASE2eftilagimod alpha, Paclitaxel
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Recent Changes (Last 90 Days)
LOWJun 8, 2026NCT06247995lastUpdatePostDate: changed
LOWJun 8, 2026NCT05870579Status: ACTIVE_NOT_RECRUITING → RECRUITING
LOWJun 8, 2026NCT06247995lastUpdatePostDate: changed
LOWJun 8, 2026NCT05870579Status: ACTIVE_NOT_RECRUITING → RECRUITING
LOWJun 8, 2026NCT06247995lastUpdatePostDate: changed
LOWJun 8, 2026NCT05870579Status: ACTIVE_NOT_RECRUITING → RECRUITING
MEDIUMJun 4, 2026NCT05870579Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJun 4, 2026NCT05870579Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJun 4, 2026NCT05870579Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJun 4, 2026NCT05870579Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWMay 28, 2026NCT05870579Completion: 2032-01-26 → 2032-04-05
LOWMay 28, 2026NCT06247995lastUpdatePostDate: changed
LOWMay 28, 2026NCT05870579Completion: 2032-01-26 → 2032-04-05
LOWMay 28, 2026NCT06247995lastUpdatePostDate: changed
LOWMay 26, 2026NCT05870579primaryCompletionDate: changed
LOWMay 26, 2026NCT06247995primaryCompletionDate: changed
LOWMay 24, 2026NCT05870579studyFirstPostDate: changed
LOWMay 24, 2026NCT06247995studyFirstPostDate: changed