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XMT-1522

Phase 1

Advanced Breast Cancer | Small molecule | Oncology |Day One Biopharmaceuticals, Inc.|Last Updated: Feb 24, 2021

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment120

FDA Designations

No designations recorded

Clinical trial landscape

XMT-1522 · 1 trial · 3 indications

Phase 1 1
NCT02952729Study of Antibody Drug Conjugate in Patients With Advanced Breast Cancer Expressing HER2Advanced Breast Cancer
COMPLETED120 Analytics
PHASE1COMPLETED
Study of Antibody Drug Conjugate in Patients With Advanced Breast Cancer Expressing HER2
Advanced Breast CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum tolerated dose or recommended Phase 2 dose
Up to 14 weeks, from the date of first dose until unacceptable side effects or a dose-limiting toxicity is met.

Evaluate adverse events and use of concomitant medication use after XMT-1522 doses

Secondary Endpoints

Time of maximum observed concentration of XMT-1522
Daily for one week after first dose; weekly until 21 days after first dose; immediately before and after and 1 week after all subsequent doses
Maximum concentration of XMT-1522
Daily for one week after first dose; weekly until 21 days after first dose; immediately before and after and 1 week after all subsequent doses
Area under the concentration curve of the last measurable concentration of XMT-1522
Daily for one week after first dose; weekly until 21 days after first dose; immediately before and after and 1 week after all subsequent doses
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose Escalation and ConfirmationEXPERIMENTALXMT-1522 treatment will administered in groups of patients who will receive doses that increase over time. Once the maximum tolerated dose or recommended Phase 2 dose is achieved, new groups of patients will receive XMT-1522 at this fixed dose.

Interventions

NameTypeDescription
XMT-1522DRUGone intravenous dose administered in-clinic every 21 days
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Able and willing to give informed consent * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Measurable disease via RECIST * Resolution of all toxic side effects from prior oncology treatments * Adequate organ function as measured by various blood param...

Countries:United States
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Competitive Landscape -Breast Cancer 402 trials (matched to "Advanced Breast Cancer")

Top 20 of 92 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN47PHASE3Fulvestrant, 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 CorpBCTX2PHASE3SV-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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Frequently asked questions about XMT-1522

What is XMT-1522 used for?

XMT-1522 is an investigational small molecule being developed for the treatment of advanced breast cancer. It is currently in Phase 1 clinical development and has been studied in patients with advanced breast cancer expressing HER2. The drug is not yet approved and remains under clinical investigation.

What does XMT-1522 target?

XMT-1522 is an antibody drug conjugate that targets HER2, a protein commonly expressed in certain breast cancers. By targeting HER2, the drug aims to deliver its therapeutic effect directly to cancer cells that express this marker, potentially improving treatment outcomes for patients with HER2-expressing advanced breast cancer.

Who makes XMT-1522?

XMT-1522 is being developed by Day One Biopharmaceuticals, Inc., a company traded on the NASDAQ under the ticker symbol DAWN. The company is focused on advancing this investigational therapy for patients with advanced breast cancer.

What phase is XMT-1522 in?

XMT-1522 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug is no longer in active clinical trials, though it remains under investigation for advanced breast cancer.

What clinical trials is XMT-1522 in?

XMT-1522 has been studied in a Phase 1 clinical trial with the identifier NCT02952729. This trial, titled 'Study of Antibody Drug Conjugate in Patients With Advanced Breast Cancer Expressing HER2,' enrolled 120 participants and has been completed. The study was conducted in the United States and included patients with advanced breast cancer, as well as advanced nonsmall cell lung cancer and advanced gastric cancer.