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GRN163L

Phase 1

Breast Cancer | Small molecule | Oncology |Geron Corporation|Last Updated: Dec 24, 2015

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

GRN163L · 2 trials · 2 indications

Phase 1 2
NCT00732056A Study of GRN163L With Paclitaxel and Bevacizumab to Treat Patients With Locally Recurrent Or Metastatic Breast CancerBreast Cancer
COMPLETED24 Analytics
NCT00124189Safety and Dose Study of GRN163L to Treat Patients With Chronic Lymphoproliferative Disease(CLD)Chronic Lymphoproliferative Diseases
COMPLETED48 Analytics
PHASE1COMPLETED
A Study of GRN163L With Paclitaxel and Bevacizumab to Treat Patients With Locally Recurrent Or Metastatic Breast Cancer
Breast CancerUnlock trial analytics
PHASE1COMPLETED
Safety and Dose Study of GRN163L to Treat Patients With Chronic Lymphoproliferative Disease(CLD)
Chronic Lymphoproliferative DiseasesUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety, MTD, efficacy
First 4 weeks
Safety, tolerability, dose-limiting toxicities (DLT), and maximum tolerated dose (MTD) or recommended phase II dose of GRN163L in patients with relapsed or refractory chronic lymphoproliferative disease
First 3 weeks

Secondary Endpoints

PK and efficacy
Baseline to end of treatment
PK and PD
Measured in the first 6 weeks
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL3+3 cohort dose escalation
open labelOTHERSequential dose cohort, open label, escalation trial evaluating one infusion duration of 2 hours

Interventions

NameTypeDescription
GRN163LDRUG25% dose escalation infused over 2 hours weekly
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Eligibility Criteria

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

Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of the breast with measurable locally recurrent or metastatic disease * May have had one prior non-taxane chemotherapy regimen for metastatic disease * If HER2 positive, must have had prior treatment with trastuzumab (He...

Countries:United States
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Competitive Landscape -Breast Cancer 402 trials

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 GRN163L

What is GRN163L used for?

GRN163L is an investigational small molecule being studied for chronic lymphoproliferative diseases and breast cancer. It has been evaluated in Phase 1 clinical trials for these oncology indications.

Who makes GRN163L?

GRN163L is being developed by Geron Corporation, a biopharmaceutical company traded on NASDAQ under the ticker symbol GERN.

What phase is GRN163L in?

GRN163L is in Phase 1 clinical development. It has completed Phase 1 trials, and it remains investigational, meaning it is not yet approved by regulatory authorities.

What clinical trials is GRN163L in?

GRN163L has been studied in two completed Phase 1 trials. One trial, NCT00124189, enrolled 48 patients with chronic lymphoproliferative diseases. Another trial, NCT00732056, enrolled 24 patients with locally recurrent or metastatic breast cancer, combining GRN163L with paclitaxel and bevacizumab.

Is GRN163L the same as imetelstat?

No, GRN163L is not the same as imetelstat. GRN163L is a distinct investigational small molecule developed by Geron Corporation for chronic lymphoproliferative diseases and breast cancer.