mTOR inhibitor · small molecule

everolimus

5 active trials across 8 of our biomarkers, targeting mTOR. Not approved for any biomarker on marked.bio yet.

Also known as RAD001, Afinitor.

Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.

Biomarkers

Biomarker	Active trials	All trials	Furthest active phase
PIK3CA activating mutation	2	5	Phase 2
ALK fusion	1	1	Phase 1
ESR1 mutation	1	1	Phase 3
KRAS G12C	1	7	Phase 1
KRAS G12D	1	7	Phase 1
BRAF V600E	0	1	–
EGFR exon 19 deletion / L858R	0	1	–
IDH1/2 mutation	0	1	–

Trials

5 of 16 trials shown

Elacestrant + Everolimus in Patients ER+/HER2-, ESR1mut, Advanced Breast Cancer Progressing to ET and CDK4/6i.

Recruiting Phase 3 MedSIR Started 2024Primary completion 2027-09 NCT06382948

everolimuselacestrant FDA EUdexamethasoneAuxiliary Medicinal Product - Luteinizing hormone-releasing hormone (LHRH) analo

Elacestrant + Everolimus in Patients ER+/HER2-, ESR1mut, Advanced Breast Cancer Progressing to ET and CDK4/6i.

ESR1 mutationAdvanced Breast Cancer, ER-positive Breast Cancer, HER2-negative Breast Cancer, ESR1 Gene Mutation
Chidamide/Everolimus for PIK3CA Wild-type/Mutant HR+/HER2- Advanced Breast Cancer

Recruiting Phase 2 Cancer Institute and Hospital, Chinese Academy of Medical Sciences Started 2023Primary completion 2026-07 NCT05983107

everolimusChidamideEndocrine therapyOvarian function suppression(OFS)

PIK3CA Mutant subjects were enrolled in queue A

PIK3CA activating mutationStatus may be outdated, last updated 2023-08-09HR+/HER2- Advanced Breast Cancer, Targeted Therapy
Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer

Active, not recruiting Phase 1/2 Stemline Therapeutics Started 2023Primary completion 2026-12 NCT05563220

elacestrantalpelisib FDA EUeverolimusribociclibpalbociclib FDA EUcapivasertib FDA EUabemaciclib

Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA) mutation by local laboratory assessment.

PIK3CA activating mutationBreast Cancer, Metastatic Breast Cancer
Phase Ib Study of Avutometinib, Defactinib, and Everolimus in RAS Pathway Mutant Endometrial Cancer

Recruiting Phase 1 M.D. Anderson Cancer Center Started 2026Primary completion 2028-08 NCT07318324

avutometinib FDAdefactinib FDAeverolimus

Participants must have histologically or cytologically confirmed recurrent RAS mutant endometrial cancer.

KRAS G12CKRAS G12DPhase IB, Avutometinib, RAS Pathway, Endometrial
Ceritinib and Everolimus in Treating Patients With Locally Advanced or Metastatic Solid Tumors or Stage IIIB-IV Non-small Cell Lung Cancer

Active, not recruiting Phase 1 M.D. Anderson Cancer Center Started 2016Primary completion 2026-12 NCT02321501

ceritinib FDA EUeverolimus

For dose expansion cohort: patients with stage IIIB or IV ALK + NSCLC who have failed at least one line of therapy and are progressing on an ALK inhibito…

ALK fusionALK Positive, Locally Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, ROS1 Gene Rearrangement
Treatment Plan for an Individual Patient With Recurrent Uterine Papillary Serous Carcinoma (UPSC) With PIK3CA Gene Mutation

Completed Phase 2/3 Greater Baltimore Medical Center Started 2017 NCT03285802

letrozoleeverolimus

…n for an Individual Patient With Recurrent Uterine Papillary Serous Carcinoma (UPSC) With PIK3CA Gene Mutation

PIK3CA activating mutationUterine Cancer
Study to Evaluate the Safety and Efficacy of Everolimus, in Subjects With PIK3CA Amplification, PTEN Loss and PIK3CA Mutation Refractory Solid Tumors

Completed Phase 2 Samsung Medical Center Started 2015 NCT02449538

everolimus

PIK3CA amplification, PTEN loss and PIK3CA mutation Refractory Solid Tumors that has recurred or progressed following standard therapy, or th…

PIK3CA activating mutationSolid Tumor
Everolimus With and Without Temozolomide in Adult Low Grade Glioma

Terminated Phase 2 University of California, San Francisco Started 2014 NCT02023905

everolimustemozolomide

…f the presence of an Isocitrate dehydrogenase 1 (IDH1) and/or Isocitrate dehydrogenase 2 (IDH2) mutation of any type.

IDH1/2 mutationLow Grade Glioma, World Health Organization (WHO) Grade II Astrocytomas, Oligodendrogliomas, Mixed Oligoastrocytomas
Phase 1b/2 Study of Retaspimycin HCl (IPI-504) in Combination With Everolimus in KRAS Mutant Non-small Cell Lung Cancer

Completed Phase 1/2 Infinity Pharmaceuticals Started 2011 NCT01427946

IPI-504everolimus

Pathological diagnosis of KRAS mutation positive NSCLC - Stage IIIB or IV

KRAS G12CKRAS G12DNon-small Cell Lung Cancer
Irinotecan, Cetuximab and Everolimus to Patients With Metastatic Colorectal Cancer

Completed Phase 2 Herlev Hospital Started 2010 NCT01387880

everolimus

Patients with KRAS-mutation in their primary tumour or metastasis.

KRAS G12CKRAS G12DMetastatic Colorectal Cancer
Study of JI-101 in Patients With Advanced Low Grade Endocrine Tumors, Ovarian Cancers or K-RAS Mutant Colon Cancers

Terminated Phase 1/2 University of Utah Started 2010 NCT01149434

JI-101everolimus

…y or cytologically confirmed metastatic/advanced ovarian carcinoma or metastatic/advanced KRAS mutant colorectal cancer or metastatic/advanced Head and neck squamous cell cancer (HNSCC) that …

KRAS G12CKRAS G12DCancer, Neuroendocrine, Ovarian Cancer, Colon Cancer
Neratinib and Everolimus, Palbociclib, or Trametinib in Treating Participants With Refractory and Advanced or Metastatic Solid Tumors With EGFR Mutation/Amplification, HER2 Mutation/Amplification, or HER3/4 Mutation or KRAS Mutation

Terminated Phase 1 M.D. Anderson Cancer Center Started 2017 NCT03065387

everolimusneratinibpalbociclibtrametinib

…nib in Treating Participants With Refractory and Advanced or Metastatic Solid Tumors With EGFR Mutation/Amplification, HER2 Mutation/Amplification, or HER3/4 Mutation or KRAS Mutation

EGFR exon 19 deletion / L858RKRAS G12CKRAS G12DAdvanced Malignant Solid Neoplasm, EGFR Gene Amplification, EGFR Gene Mutation, ERBB2 Gene Amplification
Phase I Trial of VS-6766 Alone and in Combination With Everolimus

Completed Phase 1 Royal Marsden NHS Foundation Trust Started 2013 NCT02407509

avutometinib FDAeverolimus

In Part IIC at least three patients should have KRAS mutant lung cancer.

KRAS G12CKRAS G12DSolid Tumours, Multiple Myeloma, Lung Cancer, Ovarian Cancer
Vemurafenib in Combination With Everolimus or Temsirolimus With Advanced Cancer

Completed Phase 1 M.D. Anderson Cancer Center Started 2012 NCT01596140

vemurafenib FDA EUeverolimustemozolomide

Confirmation of BRAF mutation-positive malignancy is required for selection of patients for vemurafenib therapy

BRAF V600EAdvanced Cancer, Solid Tumor
SORAVE - Sorafenib and Everolimus in Solid Tumors

Completed Phase 1 University of Cologne Started 2009 NCT00933777

sorafenibeverolimus

…th solid tumors relapsed after and/or refractory to standard therapy (dose finding part), KRAS mutated NSCLC patients after ≥ 1st relapse for the extension phase

KRAS G12CKRAS G12DUnspecified Adult Solid Tumor, Protocol Specific, Non-Small Cell Lung Cancer
A Phase 0/I Study of Ribociclib (LEE011) in Combination With Everolimus in Preoperative Recurrent High-Grade Glioma Patients Scheduled for Resection

Completed Early Phase 1 St. Joseph's Hospital and Medical Center, Phoenix Started 2019 NCT03834740

ribociclibeverolimus

…array CGH, (c) mTOR+: PTEN loss OR PIK3C2B or AKT3 amplification on aCGH OR mutations for PIK3CA or PIK3R1, or mTOR or PTEN mutations using rhAMP analysis or pS6 positivity on immunohistochemistry (≥10% for pS6).

PIK3CA activating mutationGlioblastoma Multiforme, Glioma of Brain

Biomarkers

Sponsors

Trials