Key Highlights

Risk & Performance

Pipeline Risk Assessment

Pipeline Risk Assessment

Based on historical performance

Moderate Risk

Score: 55/100

Failure Rate

20.0%

2 terminated/withdrawn out of 10 trials

Success Rate

33.3%

-53.2% vs industry average

Late-Stage Pipeline

20%

2 trials in Phase 3/4

Results Transparency

100%

1 of 1 completed trials have results

Key Signals

3 recruiting1 with results

Enrollment Performance

Analytics

Phase 1
4(44.4%)
Phase 2
3(33.3%)
Phase 3
2(22.2%)
9Total
Phase 1(4)
Phase 2(3)
Phase 3(2)

Activity Timeline

Global Presence

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Clinical Trials (10)

Showing 10 of 10 trials
NCT06190899Phase 1Recruiting

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

Role: lead

NCT05501886Phase 3Active Not Recruiting

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)

Role: lead

NCT06757634Phase 3Recruiting

Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)

Role: lead

NCT03675893Phase 2Recruiting

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

Role: collaborator

NCT05243641Phase 1Terminated

Neratinib and Capmatinib Combination (Phase Ib/II) in Metastatic Breast Cancer and Inflammatory Breast Cancer Patients With Abnormal HER-family and c-Met Pathway Activity as Measured by the CELsignia Signaling Analysis Test

Role: collaborator

NCT05134922Unknown

Expanded Access Protocol for Subjects Previously Treated With Gedatolisib in B2151009

Role: lead

NCT03911973Phase 1Active Not Recruiting

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

Role: collaborator

NCT03812393Phase 2Unknown

Evaluating the Efficacy of Neratinib on Live Cell HER2 Signaling Transduction Analysis Positive Triple Negative Breast

Role: collaborator

NCT04901299Phase 2Withdrawn

Fulvestrant + Neratinib In Breast Cancer

Role: collaborator

NCT02684032Phase 1Completed

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

Role: lead

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