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Lu-A9-0631

Phase 1

Breast Cancer | Small molecule | Oncology |BrainsWay Ltd.|Last Updated: Sep 4, 2026

Target and mechanism

Molecular targetGRPR
ModalitySmall molecule

Also known as [177Lu]Lu-A9-0631

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment115

FDA Designations

No designations recorded

Clinical trial landscape

Lu-A9-0631 · 1 trial · 4 indications

Phase 1 1
NCT07661641A Study of [177Lu]Lu-A9-0631 and [225Ac]Ac-A9-0642 With [68Ga]Ga-A9-6217 or [177Lu]Lu-A9-0631 Imaging in GRPR+ Solid TumorsBreast Cancer
RECRUITING115 Analytics
PHASE1RECRUITING
A Study of [177Lu]Lu-A9-0631 and [225Ac]Ac-A9-0642 With [68Ga]Ga-A9-6217 or [177Lu]Lu-A9-0631 Imaging in GRPR+ Solid Tumors
Breast Cancer
NCT07661641115
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Study Endpoints

Primary Endpoints

Phase 1-1b: Incidence of Adverse Events by Frequency, Duration, and Severity
From the first dose of study drug up to the End of Treatment (30 days after the last dose)

An AE is defined as any untoward medical occurrence in a participant administered study drug, which does not necessarily have to have a causal relationship with the study drug. The number of patients experiencing an AE in Part 1 will be reported.

Phase 1: Number of Patients with Dose-Limiting Toxicities (DLTs).
Up to 28 days following first study treatment

DLTs is defined as any predefined AE occurring during the DLT observation period.

Phase 1: Maximum tolerated dose (MTD)
Up to 28 days following first study treatment

Incidence of dose-limiting toxicity (DLT) per dose level of \[177Lu\]Lu-A9-0631 and/or \[225Ac\]Ac-A9-0642.

Secondary Endpoints

Phase 1-1b: Absorbed dose estimates (Gy) in normal organs for [177Lu]Lu-A9-0631 and/or [225Ac]Ac-A9-0642
Up to 7 days after each injection for up to 6 cycles (each cycle is 28 days)
Phase 1-1b: Objective Response Rate (ORR)
Every 8 ± 1 weeks until radiographic disease progression or up to 12 months after the last dose of [177Lu]Lu-A9-0631 and/or [225Ac]Ac-A9-0642
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Phase 1 Dose EscalationEXPERIMENTAL -
Phase 1B Dose ExpansionEXPERIMENTAL -

Interventions

NameTypeDescription
[68Ga]Ga-A9-6217DIAGNOSTIC_TESTAdministered IV
Low dose [177Lu]Lu-A9-0631DIAGNOSTIC_TESTAdministered IV
[177Lu]Lu-A9-0631DRUGAdministered IV
[225Ac]Ac-A9-0642DRUGAdministered IV
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Participant has provided written informed consent prior to any study-specific procedure. * Age ≥ 18 years old. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. * Have measurable target lesion per RECIST v1.1. * Progression from, intolerant to, or ineli...

Countries:Australia
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Competitive Landscape -Breast Cancer 399 trials

Top 20 of 91 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN46PHASE3Fulvestrant, Capivasertib
Merck & Co., Inc.MRK12PHASE3Pembrolizumab, Paclitaxel, Doxorubicin, Epirubicin, Cyclophosphamide
Eli Lilly and CompanyLLY27PHASE3Abemaciclib, Standard Adjuvant Endocrine Therapy
BioNTech SE Sponsored ADRBNTX7PHASE3DB-1303/BNT323, T-DM1
Gilead Sciences, Inc.GILD13PHASE3Sacituzumab Govitecan-hziy, Eribulin, Capecitabine Product, Gemcitabine, Vinorelbine
Novartis AG Sponsored ADRNVS30PHASE3Ribociclib
Pfizer Inc.PFE34PHASE3ARV-471, Fulvestrant
BeOne Medicines Ltd. Sponsored ADRONC5PHASE3BGB-43395, Letrozole, Abemaciclib, Palbociclib, Ribociclib
Olema Pharmaceuticals, Inc.OLMA5PHASE3Palazestrant, Fulvestrant, Anastrozole, Letrozole, Exemestane
Jazz Pharmaceuticals Public Limited CompanyJAZZ3PHASE3Zanidatamab, Trastuzumab, Eribulin, Vinorelbine, Gemcitabine
Celcuity Inc.CELC3PHASE3Gedatolisib, Palbociclib, Fulvestrant, Alpelisib
Relay Therapeutics, Inc.RLAY2PHASE3Zovegalisib, Capivasertib, Fulvestrant
GSK plc Sponsored ADRGSK2PHASE3Niraparib
Greenwich LifeSciences, Inc.GLSI1PHASE3GLSI-100
Bristol-Myers Squibb CompanyBMY5PHASE2Iza-bren, Nab-paclitaxel, Paclitaxel, Capecitabine, Carboplatin
BriaCell Therapeutics CorpBCTX1PHASE3SV-BR-1-GM, Cyclophosphamide, Interferon infiltration of the inoculation site, Retifanlimab, Treatment of Physician's Choice
Incyte CorporationINCY4PHASE2Ruxolitinib, Capecitabine, Regorafenib
Natera, Inc.NTRA3PHASE2Discontinuation of the anti-HER2 maintenance therapy
Puma Biotechnology, Inc.PBYI3PHASE2Neratinib, Loperamide, Colesevelam
Atossa Therapeutics, Inc.ATOS1PHASE2endoxifen, goserelin
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