marked.bio

CDK4/6 inhibitor · small molecule

ribociclib

14 active trials across 12 of our biomarkers, targeting CDK4/6. Not approved for any biomarker on marked.bio yet.

Also known as LEE011, Kisqali.

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

Biomarkers

BiomarkerActive trialsAll trialsFurthest active phase
PIK3CA activating mutation 7 11 Phase 3
BRAF V600E 2 6 Phase 2
ESR1 mutation 2 3 Phase 3
ALK fusion 1 2 Phase 2
BRCA1/2 mutation 1 1 Phase 3
EGFR exon 19 deletion / L858R 1 1 Phase 1
HER2-low / ultralow (IHC 1+ or 2+/ISH-) 1 2 Phase 1
KRAS G12C 1 3 Phase 1
KRAS G12D 1 3 Phase 1
NTRK1/2/3 fusion 1 1 Phase 2
ROS1 fusion 1 1 Phase 2
IDH1/2 mutation 0 1 –

Sponsors

Industry sponsors leading active biomarker-selected trials of ribociclib.

  1. Novartis 2
  2. AstraZeneca 2
  3. BridgeBio Oncology Therapeutics 1
  4. Eli Lilly 1
  5. Roche 1
  6. Stemline Therapeutics 1
  7. Totus Medicines 1
  8. Relay Therapeutics 1
  9. OnKure 1

Trials

14 of 28 trials shown

  1. A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA)

    Recruiting Phase 3 Eli Lilly Started 2025Primary completion 2029-05 NCT07174336

    STX-478ribociclibpalbociclib FDA EUabemaciclibanastrozoleletrozoleExemestanefulvestrant FDA EU

    Have evidence of an activating PIK3CA mutation, detected in tumor or blood samples using an appropriate assay.

    PIK3CA activating mutationBreast Neoplasms, Neoplasm Metastasis

  2. Saruparib (AZD5305) Plus Camizestrant or Plus Endocrine Therapy, Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer

    Recruiting Phase 3 AstraZeneca Started 2024Primary completion 2029-12 NCT06380751

    saruparibcamizestrantabemaciclibribociclibpalbociclibfulvestrantletrozoleanastrozoleExemestane

    Documented germline tumour loss of function mutation in BRCA1, BRCA2, or PALB2

    BRCA1/2 mutationAdvanced Breast Cancer

  3. Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6)

    Active, not recruiting Phase 3 AstraZeneca Started 2021Primary completion 2025-06 NCT04964934

    camizestrant FDAanastrozoleletrozolepalbociclibabemaciclib FDALuteinizing hormone-releasing hormone (LHRH) agonistribociclib

    Have an ESR1 mutation in their cancer;

    ESR1 mutationER-Positive HER2-Negative Breast Cancer

  4. A Phase ll, Interventional, Single-arm Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib and Fulvestrant in Chinese Patients With PIK3CA-mutant, HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer.

    Not yet recruiting Phase 2 Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Started 2026Primary completion 2028-12 NCT07618390

    inavolisib FDA EUribociclibfulvestrant FDA EU

    …fficacy and Safety of Inavolisib Plus Ribociclib and Fulvestrant in Chinese Patients With PIK3CA-mutant, HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer.

    PIK3CA activating mutationBreast Cancer

  5. A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer

    Recruiting Phase 2 Roche Started 2025Primary completion 2027-07 NCT07054190

    inavolisib FDA EUribociclibletrozolegiredestrant

    Confirmed PIK3CA mutation

    PIK3CA activating mutationBreast Cancer

  6. 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

  7. Elacestrant vs Elacestrant Plus a CDK4/6 Inhibitor in Patients With ERpositive/HER2-negative Advanced or Metastatic Breast Cancer

    Recruiting Phase 2 Northwestern University Started 2023Primary completion 2028-07 NCT06062498

    elacestrant FDA EUpalbociclibabemaciclib FDAribociclib

    Patients must have a confirmed ESR1 mutation.

    ESR1 mutationEstrogen-receptor-positive Breast Cancer, HER2/Neu-Negative Breast Cancer, Advanced Breast Cancerv, Metastatic Breast Cancer

  8. A Study Evaluating the Activity of Anti-cancer Treatments Targeting Tumor Molecular Alterations/Characteristics in Advanced / Metastatic Tumors.

    Recruiting Phase 2 Centre Leon Berard Started 2020Primary completion 2026-10 NCT04116541

    siremadlinribociclibcabozantinibalectinibregorafenibtrametinib FDA EUdabrafenib FDA EUAvapritinib

    …r amplification and/or rearrangement of VEGFR1-3, TIE-2, KIT, RET, RAF1, BRAF (other than V600 mutations), CRAF, HRAS, PDGFR, FGFR1-2, FLT3 and/or CSFR1, and/or amplification of the ligands, an…

    BRAF V600EALK fusionROS1 fusionNTRK1/2/3 fusionMalignant Solid Tumor

  9. Study of Efficacy and Safety of LXH254 Combinations in Patients With Previously Treated Unresectable or Metastatic Melanoma

    Active, not recruiting Phase 2 Novartis Started 2020Primary completion 2027-02 NCT04417621

    naporafenibLTT462trametinib FDA EUribociclib

    Participants with BRAFV600 mutant disease:

    BRAF V600EMelanoma

  10. Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

    Recruiting Phase 1 BridgeBio Oncology Therapeutics Started 2024Primary completion 2028-11 NCT06625775

    BBO-10203trastuzumabfulvestrantribociclibFOLFOXbevacizumab

    …-positive advanced breast cancer (aBC), HR-positive/HER2-negative advanced breast cancer, KRAS mutant advanced colorectal cancer (aCRC), or KRAS mutant advanced non-small cell lung cancer (aN…

    KRAS G12CKRAS G12DPIK3CA activating mutationSolid Tumor, Adult, Metastatic Breast Cancer, Advanced Breast Cancer, HER2 Mutation-Related Tumors

  11. First-in-Human Study of OKI-219 in Advanced Solid Tumors and Advanced Breast Cancer

    Active, not recruiting Phase 1 OnKure Started 2024Primary completion 2026-12 NCT06239467

    OKI-219fulvestranttrastuzumabtucatinibAtirmociclibribociclib

    Participants with HER2-low breast cancer must have received prior trastuzumab deruxtecan.

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)Advanced Cancer, Breast Cancer, Advanced Solid Tumors, PI3K Gene Mutation

  12. A Study to Evaluate the Safety and Tolerability of TOS-358 in Women With HR+ HER2- Breast Cancer

    Recruiting Phase 1 Totus Medicines Started 2023Primary completion 2027-12 NCT05683418

    TOS-358fulvestrant FDA EUpalbociclib FDA EUribociclib

    Known PIK3CA mutations or amplifications as determined at a CAP/CLIA-certified or equivalently accredited diagno…

    PIK3CA activating mutationHR+/HER2-negative Breast Cancer

  13. First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, as a Single Agent in Patients With Advanced Solid Tumors and in Combination With Endocrine Therapy +/- a CDK4/6 or CDK4 Inhibitor in Patients With Advanced Solid Tumors or Advanced Breast Cancer

    Recruiting Phase 1 Relay Therapeutics Started 2021Primary completion 2027-04 NCT05216432

    RLY-2608fulvestrant FDA EUpalbociclib FDA EUribociclibPF-07220060 100mgPF-07220060 300 mg

    One or more documented primary oncogenic PIK3CA mutation(s) in blood and/or tumor per local assessment

    PIK3CA activating mutationPIK3CA Mutation, Solid Tumor, Adult, HER2-negative Breast Cancer, Breast Cancer

  14. Study of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC

    Active, not recruiting Phase 1 Novartis Started 2018Primary completion 2026-10 NCT03333343

    nazartinibtrametinibribociclibnaporafenibcapmatinibgefitinib FDA EU

    …tologically confirmed locally advanced (stage IIIB) or metastatic (stage IV) EGFR mutant (ex19del, L858R) NSCLC.

    EGFR exon 19 deletion / L858REGFR-mutant Non-small Cell Lung Cancer