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Tucatinib

FDA-approved product (tablet, oral), marketed as Tukysa.

Registered studies
50+
Lab records
0
Pathogens at ≥40%
3 of 4

Chemical structure

Chemical structure of Tucatinib
A drawing shows what the molecule is, not what it does.

Existing / approved use

Documented · FDA, WHO, ChEMBL

Approved for

  • Breast cancer
  • Breast carcinoma
  • Breast neoplasm
  • Cancer
  • Colorectal carcinoma
  • Colorectal neoplasm
  • HER2 Positive Breast Carcinoma
  • Metastasis
  • Neoplasm

Indications ChEMBL records as approved, from FDA and DailyMed labels. Label ↗

WHO therapeutic group
Human epidermal growth factor receptor 2 (her2) tyrosine kinase inhibitors
FDA pharmacologic class
Kinase Inhibitor FDA label ↗
Anti-infective classification
Not classified as an anti-infective.

Repurposing investigation

This medicine is being investigated here for AI-predicted antimicrobial activity against M. tuberculosis, MRSA and E. coli. It was surfaced computationally for further investigation; it is not an established treatment for these infections.

AI-predicted activity

AI prediction · nothing measured
  • MRSA51.9% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • E. coli51.6% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • K. pneumoniae28.5% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • M. tuberculosis54.0% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.

A model’s estimate of laboratory activity against each pathogen species. It is not clinical effectiveness.

Evidence

Clinical and experimental

Documented evidence

Clinical

50+registered studies name this medicine, for any condition. The registry search keeps the first 50, so there may be more. See them below.

Experimental

No evidence found

No laboratory measurement against the four pathogens in the ChEMBL records loaded here.

Docking

Computational · nothing measured

Dihydrofolate reductase ↗ (E. coli)

-9.4 kcal/mol

0better fit →-12

KPC-2 carbapenemase ↗ (K. pneumoniae)

-8.5 kcal/mol

0better fit →-12

Enoyl-ACP reductase (InhA) ↗ (M. tuberculosis)

-9.6 kcal/mol

0better fit →-12

Dihydrofolate reductase ↗ (MRSA)

-10.2 kcal/mol

0better fit →-12

AutoDock Vina, one experimentally solved protein per pathogen. This project’s screening target is -7.0 kcal/mol, its own mark rather than a universal cutoff. A docking score is a structural hypothesis, not proof of binding, and requires experimental validation.

Other medicines to investigate

AI prediction · nothing measured

Other repurposing candidates: approved medicines besides Tucatinib with AI-predicted activity ≥40% against the chosen pathogen, leaving out existing antimicrobials. They are computational candidates for further investigation, not alternatives and not recommendations.

Sorted by AI-predicted activity, high to low. The order is not a ranking of which medicine is better.

Registered studies

A registration describes a study; it does not establish a positive result.

  • Tucatinib, Trastuzumab and Capecitabine With Brain and/or Spinal Radiotherapy (XRT) in Patients With HER2+, HER2 Mutated and/or HER2-amplified Metastatic Breast Cancer and Leptomeningeal Disease: A Multi-centre Phase II, Single Arm Feasibility Study

    NCT06016387 · start 2023-11-25

    Registered record
    Registry ID
    NCT06016387
    Conditions
    HER2-positive Breast Cancer; LMD
    Interventions
    Tucatinib 150 MG; Trastuzumab; Capecitabine; Brain & Spinal Radiation
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2023-11-25
    Completion
    2028-10-05
    Enrolment
    30

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionHER2-positive Breast Cancer; LMD
    InterventionTucatinib 150 MG; Trastuzumab; Capecitabine; Brain & Spinal Radiation
    PhasePhase 2
    Registry statusRecruiting
  • Study of Tucatinib and Doxil in Participants With Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Metastatic Breast Cancer

    NCT05748834 · start 2023-07-24

    Registered record
    Registry ID
    NCT05748834
    Conditions
    Breast Cancer
    Interventions
    Tucatinib; Doxil
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2023-07-24
    Completion
    2027-11
    Enrolment
    36

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionBreast Cancer
    InterventionTucatinib; Doxil
    PhasePhase 2
    Registry statusRecruiting
  • Exploiting Circulating Tumour DNA to Intensify the Postoperative Treatment Resected Colon Cancer Patients

    NCT05062889 · start 2023-05-17

    Registered record
    Registry ID
    NCT05062889
    Conditions
    Stage II Colon Cancer; Stage III Colon Cancer; HER2-positive Colon Cancer; RAS Wild-type Colon Cancer
    Interventions
    5-Fluorouracil continuous infusion FOLFOXIRI schedule; 5-Fluorouracil bolus FOLFOX schedule; 5-Fluorouracil continuous infusion FOLFOX schedule; Oxaliplatin FOLFOX and FOLFOXIRI schedule; Oxaliplatin CAPOX schedule; L-Leucovorin; Capecitabine; Irinotecan; Trifluridine/Tipiracil; Trastuzumab; Tucatinib
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Suspended
    Start
    2023-05-17
    Completion
    2029-12
    Enrolment
    477

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionStage II Colon Cancer; Stage III Colon Cancer; HER2-positive Colon Cancer; RAS Wild-type Colon Cancer
    Intervention5-Fluorouracil continuous infusion FOLFOXIRI schedule; 5-Fluorouracil bolus FOLFOX schedule; 5-Fluorouracil continuous infusion FOLFOX schedule; Oxaliplatin FOLFOX and FOLFOXIRI schedule +7 more
    PhasePhase 2
    Registry statusSuspended
  • A Phase II Study of Tucatinib and Ado-trastuzumab Emtansine (T-DM1) in Patients With HER2-positive Metastatic Solid Tumors and Metastases to Brain (TUCATEMEB)

    NCT05673928 · start 2023-05-16

    Registered record
    Registry ID
    NCT05673928
    Conditions
    Metastatic Solid Tumor; Brain Metastases
    Interventions
    Trastuzumab emtansine; Tucatinib
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2023-05-16
    Completion
    2029-03-01
    Enrolment
    30

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionMetastatic Solid Tumor; Brain Metastases
    InterventionTrastuzumab emtansine; Tucatinib
    PhasePhase 2
    Registry statusRecruiting
  • Secondary BRain Metastases Prevention After Isolated Intracranial Progression on Trastuzumab/Pertuzumab or T-DM1 in Patients With aDvanced Human Epidermal Growth Factor Receptor 2+ brEast Cancer With the Addition of Tucatinib

    NCT05323955 · start 2023-03-23

    Registered record
    Registry ID
    NCT05323955
    Conditions
    Brain Metastases; Human Epidermal Growth Factor 2 Positive Carcinoma of Breast; Advanced Breast Cancer
    Interventions
    Trastuzumab; Trastuzumab Emtansine (T-DM1); Pertuzumab; Tucatinib
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Active not recruiting
    Start
    2023-03-23
    Completion
    2027-11
    Enrolment
    48

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionBrain Metastases; Human Epidermal Growth Factor 2 Positive Carcinoma of Breast; Advanced Breast Cancer
    InterventionTrastuzumab; Trastuzumab Emtansine (T-DM1); Pertuzumab; Tucatinib
    PhasePhase 2
    Registry statusActive not recruiting
  • Tucatinib Together With Pembrolizumab and Trastuzumab

    NCT04789096 · start 2023-03-07

    Registered record
    Registry ID
    NCT04789096
    Conditions
    Breast Cancer; HER2-positive Breast Cancer
    Interventions
    Tucatinib; Pembrolizumab; Trastuzumab; Capecitabine
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Terminated
    Start
    2023-03-07
    Completion
    2025-06-04
    Enrolment
    31

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionBreast Cancer; HER2-positive Breast Cancer
    InterventionTucatinib; Pembrolizumab; Trastuzumab; Capecitabine
    PhasePhase 2
    Registry statusTerminated
  • PRE-ISPY Phase I/II Oncology Platform Program

    NCT05868226 · start 2023-02-15

    Registered record
    Registry ID
    NCT05868226
    Conditions
    HER2-positive Breast Cancer; Metastatic Cancer; Metastatic Breast Cancer; Metastatic; HER2-positive Metastatic Breast Cancer; HER2 Mutation-Related Tumors; HER-2 Protein Overexpression; HER2-negative Breast Cancer; Triple Negative Breast Cancer; HR Positive; Hormone Receptor-positive Breast Cancer; Estrogen Receptor Positive Tumor; Progesterone Receptor-positive Breast Cancer; Hormone Receptor Negative Breast Carcinoma; Solid Tumor; Solid Tumor, Adult; Solid Carcinoma; HER2 Low Breast Cancer; HER2 Low Breast Carcinoma; ER Positive Breast Cancer; PR-positive Breast Cancer; Minimal Residual Disease; Colo-rectal Cancer; Colon Cancer; Rectal Cancer; ctDNA Monitoring; Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms; Neoplasm, Residual; Adenocarcinoma of Colon; Adenocarcinoma
    Interventions
    ALX148; Fam-Trastuzumab Deruxtecan-Nxki; Zanidatamab; Tucatinib; TTX-MC138
    Study type
    INTERVENTIONAL
    Phase
    Phase 1 / Phase 2
    Registry status
    Recruiting
    Start
    2023-02-15
    Completion
    2031-12-30
    Enrolment
    280

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionHER2-positive Breast Cancer; Metastatic Cancer; Metastatic Breast Cancer; Metastatic +28 more
    InterventionALX148; Fam-Trastuzumab Deruxtecan-Nxki; Zanidatamab; Tucatinib +1 more
    PhasePhase 1 / Phase 2
    Registry statusRecruiting
  • A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer

    NCT05253651 · start 2022-10-24

    Registered record
    Registry ID
    NCT05253651
    Conditions
    Colorectal Neoplasms
    Interventions
    tucatinib; trastuzumab; bevacizumab; cetuximab; oxaliplatin; leucovorin; levoleucovorin; fluorouracil
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Recruiting
    Start
    2022-10-24
    Completion
    2030-07-03
    Enrolment
    400

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionColorectal Neoplasms
    Interventiontucatinib; trastuzumab; bevacizumab; cetuximab +4 more
    PhasePhase 3
    Registry statusRecruiting
  • Clinical Trial of Alpelisb and Tucatinib in Patients With PIK3CA-Mutant HER2+ Metastatic Breast Cancer.

    NCT05230810 · start 2022-08-25

    Registered record
    Registry ID
    NCT05230810
    Conditions
    HER2-positive Metastatic Breast Cancer
    Interventions
    Alpelisib; Tucatinib; Fulvestrant
    Study type
    INTERVENTIONAL
    Phase
    Phase 1 / Phase 2
    Registry status
    Active not recruiting
    Start
    2022-08-25
    Completion
    2026-06-30
    Enrolment
    40

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionHER2-positive Metastatic Breast Cancer
    InterventionAlpelisib; Tucatinib; Fulvestrant
    PhasePhase 1 / Phase 2
    Registry statusActive not recruiting
  • Safety and Pharmacokinetics of Tucatinib (MK-7119) in Chinese Participants With Cancer (MK-7119-002)

    NCT05382364 · start 2022-06-29

    Registered record
    Registry ID
    NCT05382364
    Conditions
    Metastatic HER2+ Advanced Breast Cancer; Breast Neoplasms; Gastric or Gastroesophageal Junction Adenocarcinoma (GEC); Colorectal Cancer
    Interventions
    Tucatinib
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Active not recruiting
    Start
    2022-06-29
    Completion
    2026-12-31
    Enrolment
    25

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionMetastatic HER2+ Advanced Breast Cancer; Breast Neoplasms; Gastric or Gastroesophageal Junction Adenocarcinoma (GEC); Colorectal Cancer
    InterventionTucatinib
    PhasePhase 1
    Registry statusActive not recruiting
  • Tucatinib in Patients With Locally Advanced or Metastatic HER2-positive Breast Cancer Who Received at Least Two Prior Anti-HER2 Treatment Regimens.

    NCT05253911 · start 2022-05-21

    Registered record
    Registry ID
    NCT05253911
    Conditions
    HER2-positive Breast Cancer
    Interventions
    TUKYSA®
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Completed
    Start
    2022-05-21
    Completion
    2025-06-30
    Enrolment
    49

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionHER2-positive Breast Cancer
    InterventionTUKYSA®
    PhaseNot recorded
    Registry statusCompleted
  • Margetuximab Plus Tucatinib and Capecitabine in HER2-positive Metastatic Breast Cancer

    NCT05227131 · start 2022-05-15

    Registered record
    Registry ID
    NCT05227131
    Conditions
    Metastatic Breast Cancer; Advanced Breast Cancer; HER2-positive Breast Cancer
    Interventions
    Margetuximab; Tucatinib; Capecitabine
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Withdrawn
    Start
    2022-05-15
    Completion
    2024-10
    Enrolment
    0

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionMetastatic Breast Cancer; Advanced Breast Cancer; HER2-positive Breast Cancer
    InterventionMargetuximab; Tucatinib; Capecitabine
    PhasePhase 2
    Registry statusWithdrawn
  • Ribociclib, Tucatinib, and Trastuzumab for the Treatment of HER2 Positive Breast Cancer

    NCT05319873 · start 2022-04-07

    Registered record
    Registry ID
    NCT05319873
    Conditions
    Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage IIA Breast Cancer AJCC v8; Anatomic Stage IIB Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IIIA Breast Cancer AJCC v8; Anatomic Stage IIIB Breast Cancer AJCC v8; Anatomic Stage IIIC Breast Cancer AJCC v8; Anatomic Stage IV Breast Cancer AJCC v8; Invasive Breast Carcinoma; Locally Advanced HER2-Positive Breast Carcinoma; Metastatic HER2-Positive Breast Carcinoma; Prognostic Stage IB Breast Cancer AJCC v8; Prognostic Stage II Breast Cancer AJCC v8; Prognostic Stage IIA Breast Cancer AJCC v8; Prognostic Stage IIB Breast Cancer AJCC v8; Prognostic Stage III Breast Cancer AJCC v8; Prognostic Stage IIIA Breast Cancer AJCC v8; Prognostic Stage IIIB Breast Cancer AJCC v8; Prognostic Stage IIIC Breast Cancer AJCC v8; Prognostic Stage IV Breast Cancer AJCC v8
    Interventions
    Carboplatin; Docetaxel; Fulvestrant; Pertuzumab; Quality-of-Life Assessment; Ribociclib; Trastuzumab; Tucatinib
    Study type
    INTERVENTIONAL
    Phase
    Phase 1 / Phase 2
    Registry status
    Active not recruiting
    Start
    2022-04-07
    Completion
    2028-04-01
    Enrolment
    18

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionAnatomic Stage II Breast Cancer AJCC v8; Anatomic Stage IIA Breast Cancer AJCC v8; Anatomic Stage IIB Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8 +16 more
    InterventionCarboplatin; Docetaxel; Fulvestrant; Pertuzumab +4 more
    PhasePhase 1 / Phase 2
    Registry statusActive not recruiting
  • A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer

    NCT05132582 · start 2022-03-07

    Registered record
    Registry ID
    NCT05132582
    Conditions
    HER2 Positive Breast Cancer
    Interventions
    Tucatinib; Trastuzumab; Pertuzumab; Combination product: Trastuzumab + Pertuzumab; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Active not recruiting
    Start
    2022-03-07
    Completion
    2027-09-28
    Enrolment
    654

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionHER2 Positive Breast Cancer
    InterventionTucatinib; Trastuzumab; Pertuzumab; Combination product: Trastuzumab + Pertuzumab +1 more
    PhasePhase 3
    Registry statusActive not recruiting
  • A Safety and Activity Study of SBT6050 in Combination With Other HER2-directed Therapies for HER2-positive Cancers

    NCT05091528 · start 2022-02-08

    Registered record
    Registry ID
    NCT05091528
    Conditions
    HER2-positive Breast Cancer; HER2-positive Gastric Cancer; HER2-positive Colorectal Cancer; HER2-expressing Non-small Cell Lung Cancer
    Interventions
    SBT6050; trastuzumab deruxtecan; tucatinib; trastuzumab; capecitabine; trastuzumab deruxtecan
    Study type
    INTERVENTIONAL
    Phase
    Phase 1 / Phase 2
    Registry status
    Terminated
    Start
    2022-02-08
    Completion
    2022-07-07
    Enrolment
    2

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionHER2-positive Breast Cancer; HER2-positive Gastric Cancer; HER2-positive Colorectal Cancer; HER2-expressing Non-small Cell Lung Cancer
    InterventionSBT6050; trastuzumab deruxtecan; tucatinib; trastuzumab +2 more
    PhasePhase 1 / Phase 2
    Registry statusTerminated