Asset profile
Tucatinib
Small molecule
Approvedregulatory verdict
Evidence outlook
Approved: TUKYSA is a kinase inhibitor indicated: • in combination with trastuzumab and... (FDA)
This approval is for an indication outside this terminal's covered markets; the covered program shown here is investigational. Regulatory approval supersedes design-level evidence grading for the approved use.
Featured evidence outside covered markets:HER2CLIMB-02 (NCT03975647) · HER2-positive Breast Cancer · Phase 3 · ungradedHER2CLIMB-05 (NCT05132582) · HER2 Positive Breast Cancer · Phase 3 · met primary endpoint · ungradedNCT04457596 · Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, HER2 Positive Breast Carcinoma, Invasive Breast Carcinoma, Multifocal Breast Carcinoma, Synchronous Bilateral Breast Carcinoma, Anatomic Stage I Breast Cancer AJCC v8 · Phase 3 · ungraded
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Featured trials
The studies most instrumental to this drug's clinical progression, individually graded on design and result. Pick an indication; Research unlocks the trials, endpoints, key results and grades.
Competitive landscape
73 competitors in this universe: 12 direct rivals (same mechanism and indication), 1 same-class, 60 same-indication; 59 further along in development.
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| Drug | Stage | Modality | Mechanism | Evidence signal | Reported efficacygraded featured trials |
|---|---|---|---|---|---|
| Tucatinib: this drug | Phase 3 | Small molecule | HER2 | ||
| Trastuzumab Deruxtecan | Approved | Antibody–drug conjugate | HER2 | ||
| Zanidatamab | Approved | Multispecific antibody | HER2 | ||
| Zongertinib | Approved | Small molecule | HER2, HER2 Mutant-selective | ||
| BL-M07D1 | Phase 3 | Antibody–drug conjugate | HER2 | ||
| Disitamab Vedotin | Phase 3 | Antibody–drug conjugate | HER2 | ||
| Trastuzumab Rezetecan | Phase 3 | Antibody–drug conjugate | HER2 | ||
| HRS-4508 | Phase 2 | Small molecule | HER2 | ||
| 177Lu-DWJ155 | Phase 1 | Radiopharmaceutical | HER2 | ||
| BL-M17D1 | Phase 1 | Antibody–drug conjugate | HER2 | ||
| KJ015 | Phase 1 | Monoclonal antibody | HER2 | ||
| MT-304 | Phase 1 | Cell therapy | HER2 | ||
| NVL-330 | Phase 1 | Small molecule | HER2 | ||
| DB-1303 | Phase 3 | Monoclonal antibody | HER2 | ||
| Afatinib (Gilotrif) | Approved | Small molecule | EGFR/HER1, HER2, HER4 | ||
| Alectinib (Alecensa) | Approved | Small molecule | ALK |
…and 58 more. Research shows the complete landscape.
Research
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Research adds each competitor's evidence grade and sourced trial results, aligned per race, so you can see who actually has the data.
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Upcoming events
(26 total)
Estimated primary-completion dates from ClinicalTrials.gov. These are registry estimates, never confirmed readout dates; they can move as trials progress.
2026 (6)
November 2026 (1)
Phase 2Brain Metastases, Human Epidermal Growth Factor 2 Positive Carcinoma of Breast, Advanced Breast CancerActive not recruiting
Est. primary completion 2026-11 · NCT05323955 · CT.gov ↗
What to watch
December 2026 (5)
Phase 2Leptomeningeal Metastasis, Leptomeningeal Disease, HER2-positive Metastatic Breast CancerRecruiting
Est. primary completion 2026-12 · NCT05800275 · CT.gov ↗
What to watch
Phase 1Metastatic HER2+ Advanced Breast Cancer, Breast Neoplasms, Gastric or Gastroesophageal Junction Adenocarcinoma (GEC), Colorectal CancerActive not recruiting
Est. primary completion 2026-12-31 · NCT05382364 · CT.gov ↗
What to watch
Phase 1Advanced Cancer, Breast Cancer, Advanced Solid Tumors, PI3K Gene MutationActive not recruiting
Est. primary completion 2026-12-31 · NCT06239467 · CT.gov ↗
What to watch
Phase 2HER2-positive Breast Cancer, LMDRecruiting
Est. primary completion 2026-12-31 · NCT06016387 · CT.gov ↗
What to watch
Phase 2Lymphoma, Non-Hodgkin, Multiple Myeloma, Advanced Solid TumorsRecruiting
Est. primary completion 2026-12-31 · NCT03297606 · CT.gov ↗
What to watch
2027 (11)
March 2027 (2)
April 2027 (1)
Phase 1/2Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8 …Active not recruiting
Est. primary completion 2027-04-01 · NCT05319873 · CT.gov ↗
What to watch
June 2027 (1)
Phase 2Breast Cancer, Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast CancerActive not recruiting
Est. primary completion 2027-06-01 · NCT05458674 · CT.gov ↗
What to watch
July 2027 (1)
Phase 2Adenocarcinoma of the Rectum, Locally Advanced Rectal Adenocarcinoma, Rectal Adenocarcinoma, HER2 Positive Rectal Adenocarcinoma …Recruiting
Est. primary completion 2027-07-30 · NCT05672524 · CT.gov ↗
What to watch
November 2027 (2)
December 2027 (4)
Phase 2HER2-positive Breast CancerRecruiting
Est. primary completion 2027-12-19 · NCT05955170 · CT.gov ↗
What to watch
Phase 1/2HER 2 Positive Advanced Breast Cancer, Breast CancerNot yet recruiting
Est. primary completion 2027-12-31 · NCT07494448 · CT.gov ↗
What to watch
Phase 2Lymphoma, Non-Hodgkin, Multiple Myeloma, Advanced Solid TumorsRecruiting
Est. primary completion 2027-12-31 · NCT02693535 · CT.gov ↗
What to watch
Phase 3Colorectal NeoplasmsRecruiting
Est. primary completion 2027-12-31 · NCT05253651 · CT.gov ↗
What to watch
2028 (3)
January 2028 (1)
Phase 3Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, HER2 Positive Breast Carcinoma …Active not recruiting
Est. primary completion 2028-01-31 · NCT04457596 · CT.gov ↗
What to watch
May 2028 (1)
Phase 2Metastatic Breast CancerActive not recruiting
Est. primary completion 2028-05-09 · NCT05892068 · CT.gov ↗
What to watch
December 2028 (1)
Phase 2Metastatic Breast Cancer ( HER2 Negative), Unresectable Breast CancerRecruiting
Est. primary completion 2028-12-07 · NCT07193394 · CT.gov ↗
What to watch
2029 (1)
July 2029 (1)
Phase 2Breast Neoplasms, Gastroesophageal Junction Adenocarcinoma, HER2 Low Breast Neoplasms, HER2 Positive Breast Neoplasms, Stomach Neoplasms …Active not recruiting
Est. primary completion 2029-07-28 · NCT06157892 · CT.gov ↗
What to watch
2030 (4)
March 2030 (1)
Phase 2Breast Cancer Female, Breast Cancer, Breast Cancer Metastatic, Estrogen Receptor-positive Breast Cancer, HER2-positive Breast Cancer …Recruiting
Est. primary completion 2030-03-30 · NCT06439693 · CT.gov ↗
What to watch
April 2030 (1)
Phase 1/2Breast Neoplasms, Breast CancerRecruiting
Est. primary completion 2030-04-18 · NCT06686394 · CT.gov ↗
What to watch
December 2030 (2)
Phase 2Breast Neoplasms, Breast Cancer, Breast Tumors, Angiosarcoma, TNBC - Triple-Negative Breast Cancer, HER2-positive Breast Cancer …Recruiting
Est. primary completion 2030-12 · NCT01042379 · CT.gov ↗
What to watch
Phase 1/2HER2-positive Breast Cancer, Metastatic Cancer, Metastatic Breast Cancer, Metastatic, HER2-positive Metastatic Breast Cancer …Recruiting
Est. primary completion 2030-12-30 · NCT05868226 · CT.gov ↗
What to watch
2032 (1)
March 2032 (1)
Phase 4Non-Small Cell Lung CancerNot yet recruiting
Est. primary completion 2032-03-13 · NCT07768358 · CT.gov ↗
What to watch
All registered studies
Every ClinicalTrials.gov study of this drug's own program, grouped by indication and phase. Research unlocks the studies themselves: titles, statuses, dates and featured-trial cross-links.