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Taselisib

Phase 1

Metastatic Breast Cancer | Small molecule | Oncology |SS Innovations International Inc.|Last Updated: Apr 9, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment68

FDA Designations

No designations recorded

Clinical trial landscape

Taselisib · 1 trial · 2 indications

Phase 1 1
NCT02390427Phase Ib Dose-escalation Trial of Taselisib (GDC-0032) in Combination With Anti-HER2 Therapies in Participants With Advanced HER2+ Breast CancerMetastatic Breast Cancer
COMPLETED68 Analytics
PHASE1COMPLETED
Phase Ib Dose-escalation Trial of Taselisib (GDC-0032) in Combination With Anti-HER2 Therapies in Participants With Advanced HER2+ Breast Cancer
Metastatic Breast CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum Tolerated Dose (MTD) of Taselisib in combination with anti-HER2 therapy(ies) and/or paclitaxel.
28 Days

Secondary Endpoints

Clinical Benefit Rate (CBR) for efficacy of Taselisib in combination with anti-HER2 therapy(ies) and/or paclitaxel.
> or = 6 Months
Progression Free Survival (PFS) for efficacy of Taselisib in combination with anti-HER2 therapy(ies) and/or paclitaxel.
2 Years
Overall Survival for efficacy of Taselisib in combination with anti-HER2 therapy(ies) and/or paclitaxel.
2 Years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm AEXPERIMENTALArm A \- Taselisib with Trastuzumab emtansine (also called T-DM1) * Taselisib administered orally, daily in each treatment cycle (3 weeks). * Trastuzumab emtansine (also called T-DM1) administered once via IV per treatment cycle (3 weeks).
Arm BEXPERIMENTALArm B -Taselisib with T-DM1 and Pertuzumab * Taselisib is administered oral, daily or every other day per treatment cycle (3 weeks). * Trastuzumab emtansine (also called T-DM1) administered once via IV per treatment cycle (3 weeks). * Pertuzumab- administered once via IV per treatment cycle (3 weeks).
Arm CEXPERIMENTALArm C: * Taselisib with Pertuzumab and Trastuzumab * Cohort C will not open without additional authorization from Genentech * Taselisib is administered oral, daily in each treatment cycle (3 weeks). * Trastuzumab administered once via IV per treatment cycle (3 weeks). * Pertuzumab- administered once via IV per treatment cycle (3 weeks).
Arm DEXPERIMENTALArm D * Taselisib with Pertuzumab, Trastuzumab, and Paclitaxel * Cohort will not be opened without additional authorization from Genentech * Taselisib- administered oral, daily in each treatment cycle (3 weeks). * Pertuzumab- administered once via IV per treatment cycle (3 weeks). * Trastuzumab administered once via IV per treatment cycle (3 weeks). * Paclitaxel- administered via IV, weekly for 3 weeks within each cycle.

Interventions

NameTypeDescription
TaselisibDRUG -
Trastuzumab emtansineDRUG -
PertuzumabDRUG -
TrastuzumabDRUG -
PaclitaxelDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Metastatic, locally advanced , or locally recurrent breast cancer * Histologically confirmed HER2+ invasive breast cancer * Measurable or non-measurable disease per RECIST v1.1 * Prior therapy - Prior trastuzumab, lapatinib, pertuzumab, and trastuzumab emtansine (T-DM1) are al...

Countries:United States
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Competitive Landscape -Breast Cancer 402 trials (matched to "Metastatic 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 Taselisib

What is Taselisib used for in Metastatic Breast Cancer?

Taselisib is an investigational small molecule being studied for the treatment of Metastatic Breast Cancer, specifically in combination with anti-HER2 therapies for advanced HER2+ breast cancer. It is currently in Phase 1 clinical development and is not approved by the FDA.

What does Taselisib target?

Taselisib is a small molecule designed to target cancer cells in HER2+ breast cancer. It is being evaluated in combination with anti-HER2 therapies to treat advanced HER2+ breast cancer, including metastatic and recurrent forms of the disease.

Who makes Taselisib?

Taselisib is being developed by SS Innovations International Inc., a company traded under the ticker symbol SSII. The drug is currently in Phase 1 clinical development for the treatment of Metastatic Breast Cancer.

What phase is Taselisib in?

Taselisib is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA and is still undergoing clinical trials to evaluate its safety and efficacy in patients with Metastatic Breast Cancer.

What clinical trials is Taselisib in?

Taselisib has one completed clinical trial, NCT02390427, a Phase Ib dose-escalation study of Taselisib in combination with anti-HER2 therapies in participants with advanced HER2+ breast cancer. The trial enrolled 68 participants in the United States and is now completed.