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RG1507

Phase 1

Breast Cancer | Small molecule | Oncology |Roche Holding AG|Last Updated: Nov 2, 2016

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment8

FDA Designations

No designations recorded

Clinical trial landscape

RG1507 · 3 trials · 2 indications

Phase 1 3
NCT00882674A Study to Evaluate the Biological Activity of R1507 in Women With Operable Breast CancerBreast Cancer
COMPLETED8 Analytics
NCT00560144A Multiple Ascending Dose Study of R1507 in Children and Adolescents With Advanced Solid Tumors.Neoplasms
COMPLETED34 Analytics
NCT00400361A Multiple Ascending Dose Study of R1507 in Patients With Advanced Solid Tumors.Neoplasms
COMPLETED98 Analytics
PHASE1COMPLETED
A Study to Evaluate the Biological Activity of R1507 in Women With Operable Breast Cancer
Breast CancerUnlock trial analytics
PHASE1COMPLETED
A Multiple Ascending Dose Study of R1507 in Children and Adolescents With Advanced Solid Tumors.
NeoplasmsUnlock trial analytics
PHASE1COMPLETED
A Multiple Ascending Dose Study of R1507 in Patients With Advanced Solid Tumors.
NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

Percent reduction in IGF-1R expression
From initial diagnosis to tumor excision
Serum drug exposure level equivalent to exposure in adults at adult recommended dose.
Throughout study
AEs, laboratory parameters, Cmax, Tmax, AUC, clearance, Vdss elimination half life
Throughout study

Secondary Endpoints

Correlation of R1507 pharmacokinetic parameters with biological changes in tumor tissue
Days 1, 8 and 31
Adverse events, laboratory parameters
Throughout study
MTD (AEs, laboratory parameters)
Throughout study
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -
3EXPERIMENTAL -

Interventions

NameTypeDescription
RG1507DRUG16mg/kg, 9mg/kg, 3mg/kg or 1mg/kg iv on Day 1 in one of 4 cohorts of patients
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * female patients, \>=18 years of age; * invasive, and operable, breast cancer; * ECOG Performance Status of 0 or 1. Exclusion Criteria: * evidence of metastatic disease; * inflammatory breast cancer; * prior hormonal or systemic therapy for breast cancer; * prior treatment wi...

Countries:United KingdomUnited 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 RG1507

What is RG1507 used for?

RG1507 is an investigational small molecule being studied for the treatment of breast cancer and other neoplasms, or solid tumors. It has been evaluated in Phase 1 clinical trials in patients with advanced solid tumors, including a study specifically in women with operable breast cancer.

Who makes RG1507?

RG1507 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company has sponsored multiple Phase 1 clinical trials of the drug in patients with advanced solid tumors and breast cancer.

What phase is RG1507 in?

RG1507 is in Phase 1 clinical development. It has completed two Phase 1 trials in adults and one Phase 1 trial in children and adolescents with advanced solid tumors. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is RG1507 in?

RG1507 has been studied in three completed Phase 1 trials: NCT00400361, a multiple ascending dose study in adults with advanced solid tumors; NCT00560144, a similar study in children and adolescents; and NCT00882674, a study evaluating biological activity in women with operable breast cancer.

Is RG1507 the same as R1507?

Yes, RG1507 is also known as R1507. The drug has been referred to by both names in clinical trial records, including studies NCT00400361, NCT00560144, and NCT00882674, which all use the R1507 designation.