Gedatolisib

DRUG12 trials

Sponsors

Celcuity Inc., Hoffman Oncology, Celcuity Inc, University of Florida, Dana-Farber Cancer Institute

Conditions

Breast CancerBreast Neoplasm Malignant FemaleEndometrial CancerGenital Diseases, MaleHead & Neck CancerLung Cancer Squamous CellMetastasic Castration-Resistant Prostate Cancer (mCRPC)Metastatic Breast Cancer

Phase 1

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

Hoffman OncologyBreast Cancer

Start: 2016-01-31End: 2022-03-15Target: 18Updated: 2022-02-09

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

CompletedNCT02684032

Celcuity IncBreast Cancer

Start: 2016-06-14End: 2022-01-19Updated: 2022-07-27

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

TerminatedNCT02920450

University of FloridaNon-Small Cell Lung Cancer

Start: 2017-09-25End: 2019-04-04Updated: 2019-10-04

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

SuspendedNCT03065062

Dana-Farber Cancer InstituteHead & Neck Cancer, Lung Cancer Squamous Cell, Pancreatic Cancer +1

Start: 2017-02-28End: 2027-01-31Target: 75Updated: 2026-02-13

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

CompletedNCT03243331

Kathy MillerMetastatic Breast Cancer, Triple Negative Breast Cancer

Start: 2018-01-19End: 2020-05-27Updated: 2021-01-07

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

WithdrawnNCT03400254

Abramson Cancer Center at Penn MedicineBreast Cancer

Start: 2019-02-26End: 2019-11-12Updated: 2020-04-28

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

Active, not recruitingNCT03911973

Kari WisinskiTNBC - Triple-Negative Breast Cancer

Start: 2019-04-17End: 2024-07-31Target: 37Updated: 2024-06-07

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

RecruitingNCT06190899

Celcuity IncGenital Diseases, Male, mCRPC (Metastatic Castration-resistant Prostate Cancer), Prostate Cancer +3

Start: 2024-01-01End: 2027-11-30Target: 54Updated: 2025-03-21

A Phase 1/2, Open-Label, Randomized, Dose Finding and Dose Expansion Study of Gedatolisib in Combination with Darolutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC)

RecruitingCTIS2023-505898-32-00

Celcuity Inc.Metastasic Castration-Resistant Prostate Cancer (mCRPC)

Start: 2024-02-28Target: 40Updated: 2025-12-23

Phase 2

RESOLVE: Abemaciclib + Letrozole +/- Metformin, Zotatifin, or Gedatolisib in Endometrial or Low-Grade Serous Ovarian Cancer

RecruitingNCT03675893

Dana-Farber Cancer InstituteEndometrial Cancer, Ovarian Cancer

Start: 2018-12-24End: 2031-08-01Target: 180Updated: 2025-06-15

Phase 3

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 recruitingNCT05501886

Celcuity IncBreast Cancer

Start: 2022-12-08End: 2026-12-31Target: 701Updated: 2026-02-10

Unknown Phase

Expanded Access Protocol for Subjects Previously Treated With Gedatolisib in B2151009

Celcuity IncBreast Neoplasm Malignant Female

Updated: 2025-03-21

Related Papers

VIKTORIA-1 Trial of Gedatolisib Plus Fulvestrant With or Without Palbociclib in Hormone Receptor-Positive/HER2-/PIK3CA Wild-Type Advanced Breast Cancer.

2026-03-09

Letrozole, abemaciclib and metformin in endometrial cancer: a non-randomized phase 2 trial.

2025-12-03

Abstract P4-08-25: Overall survival in patients with HR+/HER2- advanced breast cancer treated in a phase 1b trial evaluating gedatolisib in combination with palbociclib and endocrine therapy

Clinical Cancer Research2025-06-13

Phase I/II trial investigating gedatolisib plus talazoparib in advanced triple negative or BRCA1/2 positive, HER2 negative breast cancers.

2025-06-05

Phase 2 study of letrozole, abemaciclib, and metformin in estrogen receptor (ER)–positive recurrent endometrial cancer (EC).

Journal of Clinical Oncology2025-05-283 citations

A phase 1/2, open-label, randomized, dose-finding and dose expansion study of gedatolisib in combination with darolutamide in metastatic castration-resistant prostate cancer (mCRPC).

Journal of Clinical Oncology2024-06-01

Abstract CT087: A phase 1/2, open-label, randomized, dose-finding and dose expansion study of gedatolisib in combination with darolutamide in metastatic castration-resistant prostate cancer (mCRPC)

Cancer Research2024-04-05

Gedatolisib in combination with palbociclib and endocrine therapy in women with hormone receptor-positive, HER2-negative advanced breast cancer: results from the dose expansion groups of an open-label, phase 1b study.

2024-04-0132 citations

A phase 3 study of gedatolisib plus fulvestrant with and without palbociclib in patients with HR+/ HER2- advanced breast cancer previously treated with a CDK4/6 inhibitor plus a nonsteroidal aromatase inhibitor (VIKTORIA-1).

Journal of Clinical Oncology2023-06-0117 citations

Abstract CT063: A Phase 3 study of gedatolisib plus fulvestrant with and without palbociclib in patients with HR+/HER2- advanced breast cancer previously treated with a CDK4/6 inhibitor plus a non-steroidal aromatase inhibitor (VIKTORIA-1)

Cancer Research2023-04-142 citations

Results of the safety run-in of gedatolisib plus talazoparib in advanced triple negative or BRCA 1/2 positive HER2 negative breast cancer.

Journal of Clinical Oncology2022-06-013 citations

Abstract P4-01-07: Insights into the compensation mechanism behind targeting PI3K and Wnt in triple-negative breast cancer

Cancer Research2022-02-15

Actionable Molecular Alterations Are Revealed in Majority of Advanced Non-Small Cell Lung Cancer Patients by Genomic Tumor Profiling at Progression after First Line Treatment

Cancers2021-12-287 citations

First-in-Human Study of PF-06647020 (Cofetuzumab Pelidotin), an Antibody–Drug Conjugate Targeting Protein Tyrosine Kinase 7, in Advanced Solid Tumors

Clinical Cancer Research2021-06-0375 citations

Abstract PS10-26: An initial safety study of gedatolisib plus cofetuzumab pelidotin for metastatic triple-negative breast cancer

Cancer Research2021-02-151 citations

Biomarker analysis from a phase I study using gedatolisib+palbociclib+hormone therapy in ER+/HER2- metastatic breast cancer (mBC).

Journal of Clinical Oncology2020-05-20

Abstract OT3-06-02: An initial safety study of gedatolisib plus PTK7-ADC for metastatic triple-negative breast cancer

Cancer Research2019-02-158 citations

Phase Ib study of gedatolisib in combination with palbociclib and endocrine therapy (ET) in women with estrogen receptor (ER) positive (+) metastatic breast cancer (MBC) (B2151009).

Journal of Clinical Oncology2018-05-2015 citations

A Multi-Arm Phase I Study of the PI3K/mTOR Inhibitors PF-04691502 and Gedatolisib (PF-05212384) plus Irinotecan or the MEK Inhibitor PD-0325901 in Advanced Cancer.

2017-12-0178 citations

Phase Ib study to assess the safety, tolerability, and clinical activity of gedatolisib in combination with palbociclib and either letrozole or fulvestrant in women with metastatic or locally advanced/recurrent breast cancer (B2151009; NCT02684032).

Journal of Clinical Oncology2017-05-205 citations