marked.bio

HER2 TKI · small molecule

tucatinib

7 active trials across 5 of our biomarkers, targeting HER2. Not approved for any biomarker on marked.bio yet.

Also known as ONT-380, Tukysa.

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
HER2-low / ultralow (IHC 1+ or 2+/ISH-) 3 3 Phase 2
HER2 (ERBB2) activating mutation 2 2 Phase 2
EGFR exon 19 deletion / L858R 1 1 Phase 1
PIK3CA activating mutation 1 1 Phase 1/2
BRAF V600E 0 1 –

Sponsors

Industry sponsors leading active biomarker-selected trials of tucatinib.

  1. Pfizer 2
  2. Criterium 1
  3. Pieris Pharmaceuticals 1
  4. OnKure 1

Trials

7 of 8 trials shown

  1. A Study of Disitamab Vedotin With Other Anticancer Drugs in Solid Tumors

    Active, not recruiting Phase 2 Pfizer Started 2024Primary completion 2029-07 NCT06157892

    disitamab vedotintucatinib

    Cohort A (HER2-Low Breast Cancer) Inclusion Criteria

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)Breast Neoplasms, Gastroesophageal Junction Adenocarcinoma, HER2 Low Breast Neoplasms, HER2 Positive Breast Neoplasms

  2. A Study of Tucatinib Given Before Surgery to People With HER2+ Cancers That Have Spread to the Brain

    Active, not recruiting Phase 2 Memorial Sloan Kettering Cancer Center Started 2023Primary completion 2028-05 NCT05892068

    tucatinib

    …ymal progression in patients with HER2+/mutant lung/esophagogastric/colorectal cancer and HER2 mutant breast cancer

    HER2 (ERBB2) activating mutationMetastatic Breast Cancer

  3. Clinical Trial of Alpelisb and Tucatinib in Patients With PIK3CA-Mutant HER2+ Metastatic Breast Cancer.

    Active, not recruiting Phase 1/2 Criterium Started 2022Primary completion 2026-03 NCT05230810

    alpelisib FDA EUtucatinibfulvestrant FDA EU

    Documented presence of activating mutation in PIK3CA in the tumor, based on the analysis of solid or liquid biopsy by an assay approved for cl…

    PIK3CA activating mutationHER2-positive Metastatic Breast Cancer

  4. Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations

    Active, not recruiting Phase 2 Pfizer Started 2021Primary completion 2023-11 NCT04579380

    tucatinibtrastuzumabfulvestrant

    Known activating HER2 mutations detected in fresh or archival tumor tissue or blood

    HER2 (ERBB2) activating mutationUterine Neoplasms, Uterine Cervical Neoplasms, Biliary Tract Neoplasms, Urologic Neoplasms

  5. Cinrebafusp Alfa in Combination With Ramucirumab and Paclitaxel in HER2-High Gastric or GEJ Adenocarcinoma and in Combination With Tucatinib in HER2-Low Gastric or GEJ Andenocarinoma

    Active, not recruiting Phase 2 Pieris Pharmaceuticals Started 2021Primary completion 2023-02 NCT05190445

    ramucirumabpaclitaxeltucatinib

    …aclitaxel in HER2-High Gastric or GEJ Adenocarcinoma and in Combination With Tucatinib in HER2-Low Gastric or GEJ Andenocarinoma

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)Status may be outdated, last updated 2022-09-08HER2-positive Gastric Cancer

  6. Osimertinib, Cetuximab, and Tucatinib for the Treatment of EGFR-Mutant Stage IV or Recurrent Non-small Lung Cell Cancer

    Not yet recruiting Phase 1 Jonathan Riess Started 2024Primary completion 2025-01 NCT06067776

    cetuximabosimertinib FDA EUtucatinib

    NSCLC must harbor at least one of the following EGFR activating mutations: Exon 21 L858R, Exon 19 deletion, Exon 18 G719X, Exon 21 L861Q, Exon 20 S768I.

    EGFR exon 19 deletion / L858RStatus may be outdated, last updated 2023-10-05Metastatic Lung Non-Small Cell Carcinoma, Recurrent Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8

  7. 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