Gedatolisib

Phase 3Small molecule

HHoffman Oncology

Gedatolisib is one of 159 small molecule programs targeting Triple-Negative Breast Cancer. It is currently in Phase 3.

Indications

Total Trials

Active Trials

158

Competitors

Pipeline

Status by Indication[3][1]

Indication

Triple-Negative Breast CancerActive, not recruiting

Breast CancerActive, not recruiting

Prostate CancerActive, not recruiting

Ovarian CancerActive, not recruiting

Endometrial CancerRecruiting

Triple-Negative Breast CancerPhase 1

Active, not recruiting

Breast CancerPhase 3

Active, not recruiting

Prostate CancerPhase 1/Phase 2

Active, not recruiting

Ovarian CancerPhase 2

Active, not recruiting

Endometrial CancerPhase 2

Recruiting

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Gedatolisib

HHoffman Oncology

Phase 3

5 2

Trodelvy

Gilead

Preclinical

37 3

Cymbalta

Alnylam Pharmaceuticals

Preclinical

3 4

Blenoxane

Bristol-Myers Squibb

Preclinical

1 5

Recentin

NNational Cancer Institute (NCI)

Preclinical

2 6

Spravato

WWim Janssens

Preclinical

2 7

Avastin

Roche

Preclinical

4 8

Nubain

AAultman Health Foundation

Preclinical

1 9

Feraheme

AAzurity Pharmaceuticals

Preclinical

1 10

Systemic Therapy

Bristol-Myers Squibb

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 3Active, not recruiting

Breast Cancer

NCT05501886

Q4 2027

Phase 1/2Recruiting

Prostate Cancer

NCT06190899

Q3 2031

Phase 2Recruiting

Endometrial Cancer

NCT03675893

Clinical

Trials by Indication[1]

Breast Cancer5 trials

Gedatolisib Plus Talazoparib in Advanced Triple Negative or BRCA1/2 Positive, HER2 Negative Breast Cancers

Active, not recruiting·KKari Wisinski·Phase 1/2·NCT03911973·37 enrolled

Gedatolisib, Hydroxychloroquine or the Combination for Prevention of Recurrent Breast Cancer ("GLACIER")

Withdrawn·—·Phase 1/2·NCT03400254

Phase I Study of Combination of Gedatolisib With Palbociclib and Faslodex in Patients With ER+/HER2- Breast Cancer

Unknown status·HHoffman Oncology·Phase 1·NCT02626507·18 enrolled

Show 2 more trials

A Study To Assess The Tolerability And Clinical Activity Of Gedatolisib In Combination With Palbociclib/Letrozole Or Palbociclib/Fulvestrant In Women With Metastatic Breast Cancer

Completed·CCelcuity Inc·Phase 1·NCT02684032·141 enrolled

Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1)

Active, not recruiting·CCelcuity Inc·Phase 3·NCT05501886·701 enrolled

Prostate Cancer1 trial

Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer

Recruiting·CCelcuity Inc·Phase 1/2·NCT06190899·54 enrolled

Advanced or Metastatic NSCLC1 trial

Study of Paclitaxel, Carboplatin, and PF-05212384 in Advanced or Metastatic NSCLC (UF-STO-LUNG-002)

Terminated·UUniversity of Florida·Phase 1/2·NCT02920450·3 enrolled

Other Solid Tumors1 trial

Study of the CDK4/6 Inhibitor Palbociclib (PD-0332991) in Combination With the PI3K/mTOR Inhibitor Gedatolisib (PF-05212384) for Patients With Advanced Squamous Cell Lung, Pancreatic, Head & Neck and Other Solid Tumors

Suspended·—·Phase 1·NCT03065062·75 enrolled

Triple-Negative Breast Cancer1 trial

An Initial Safety Study of Gedatolisib Plus PTK7-ADC for Metastatic Triple-negative Breast Cancer

Completed·KKathy Miller·Phase 1·NCT03243331·18 enrolled

2 more indications

ESS1 trial

Expanded Access Protocol for Subjects Previously Treated With Gedatolisib in B2151009

Available·CCelcuity Inc··NCT05134922

Endometrial Cancer1 trial

RESOLVE: A Multi-Cohort Phase 2 Study of Letrozole/Abemaciclib Alone and in Combination With Metformin and Gedatolisib

Recruiting·DDana-Farber Cancer Institute·Phase 2·NCT03675893·110 enrolled

Sources

References

[1]
ClinicalTrials.gov — 11 trial records for Gedatolisib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Gedatolisib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Gedatolisib. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Hoffman Oncology company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: HHoffman Oncology

Gedatolisib

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q4 2027

Q3 2031

Trials by Indication[1]

Breast Cancer5 trials

Prostate Cancer1 trial

Advanced or Metastatic NSCLC1 trial

Other Solid Tumors1 trial

Triple-Negative Breast Cancer1 trial

ESS1 trial

Endometrial Cancer1 trial

References

Drug Info

Quick Facts

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