Numerous clinical trials evaluate tucatinib across phases 1 through 3—including phase 2 combination studies and healthy volunteer trials—primarily targeting HER2-positive metastatic breast cancer, colorectal adenocarcinoma, gastric or gastroesophageal junction adenocarcinoma, and solid malignancies with leptomeningeal disease. Sponsored by pharmaceutical leaders, academic institutions, and clinical research entities, these studies demonstrate recruitment statuses ranging from actively recruiting and active, not recruiting to completed, not yet recruiting, or withdrawn.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07768358 | NOT_YET_RECRUITING | HER2-positive Breast Cancer; Cervical Cancer; Biliary Tract Neoplasms; Urothelial Cancer; Advanced Non-Small Cell Lung Cancer; Gastric or Gastroesophageal Junction Adenocarcinoma (GEC); Colorectal Cancer |
Pfizer |
2026-11-06 | PHASE4 |
| NCT05868226 | RECRUITING | 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 |
QuantumLeap Healthcare Collaborative |
2023-02-15 | PHASE1; PHASE2 |
| NCT01042379 | RECRUITING | Breast Neoplasms; Breast Cancer; Breast Tumors; Angiosarcoma; TNBC - Triple-Negative Breast Cancer; HER2-positive Breast Cancer; HER2-negative Breast Cancer; Hormone Receptor Positive Tumor; Hormone Receptor Negative Tumor; Early-stage Breast Cancer; Locally Advanced Breast Cancer |
QuantumLeap Healthcare Collaborative |
2010-03-01 | PHASE2 |
| NCT06686394 | RECRUITING | Breast Neoplasms; Breast Cancer |
Merck Sharp & Dohme LLC |
2025-02-26 | PHASE1; PHASE2 |
| NCT06439693 | RECRUITING | Breast Cancer Female; Breast Cancer; Breast Cancer Metastatic; Estrogen Receptor-positive Breast Cancer; HER2-positive Breast Cancer; Stage IV Breast Cancer |
Dana-Farber Cancer Institute |
2024-08-08 | PHASE2 |
| NCT06157892 | ACTIVE_NOT_RECRUITING | Breast Neoplasms; Gastroesophageal Junction Adenocarcinoma; HER2 Low Breast Neoplasms; HER2 Positive Breast Neoplasms; Stomach Neoplasms; Triple Negative Breast Neoplasms; Metastatic Breast Cancer; Metastatic Gastric Cancer; Advanced Breast Cancer; Advanced Gastric Cancer |
Seagen, a wholly owned subsidiary of Pfizer |
2024-05-20 | PHASE2 |
| NCT07413939 | RECRUITING | HER2-positive Breast Cancer |
Hoffmann-La Roche |
2026-05-21 | PHASE2; PHASE3 |
| NCT07193394 | RECRUITING | Metastatic Breast Cancer ( HER2 Negative); Unresectable Breast Cancer |
Institut Curie |
2026-01-31 | PHASE2 |
| NCT05892068 | ACTIVE_NOT_RECRUITING | Metastatic Breast Cancer |
Memorial Sloan Kettering Cancer Center |
2023-05-09 | PHASE2 |
| NCT04457596 | ACTIVE_NOT_RECRUITING | 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 |
Alliance for Clinical Trials in Oncology |
2021-03-02 | PHASE3 |
| NCT07494448 | NOT_YET_RECRUITING | HER 2 Positive Advanced Breast Cancer; Breast Cancer |
MedSIR |
2026-07-01 | PHASE1; PHASE2 |
| NCT05253651 | RECRUITING | Colorectal Neoplasms |
Seagen, a wholly owned subsidiary of Pfizer |
2022-10-24 | PHASE3 |
| NCT02693535 | RECRUITING | Lymphoma, Non-Hodgkin; Multiple Myeloma; Advanced Solid Tumors |
American Society of Clinical Oncology |
2016-03-14 | PHASE2 |
| NCT05955170 | RECRUITING | HER2-positive Breast Cancer |
Institut Curie |
2023-12-19 | PHASE2 |
| NCT07318389 | NOT_YET_RECRUITING | Dynamic Tumor Resistance; Metastatic Colorectal Cancer |
M.D. Anderson Cancer Center |
2026-06-10 | EARLY_PHASE1 |
| NCT05748834 | RECRUITING | Breast Cancer |
SCRI Development Innovations, LLC |
2023-07-24 | PHASE2 |
| NCT05062889 | SUSPENDED | Stage II Colon Cancer; Stage III Colon Cancer; HER2-positive Colon Cancer; RAS Wild-type Colon Cancer |
Gruppo Oncologico del Nord-Ovest |
2023-05-17 | PHASE2 |
| NCT05672524 | RECRUITING | Adenocarcinoma of the Rectum; Locally Advanced Rectal Adenocarcinoma; Rectal Adenocarcinoma; HER2 Positive Rectal Adenocarcinoma; Rectal Cancer |
Memorial Sloan Kettering Cancer Center |
2022-12-30 | PHASE2 |
| NCT05458674 | ACTIVE_NOT_RECRUITING | Breast Cancer; Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Cancer |
Criterium, Inc. |
2024-01-30 | PHASE2 |
| NCT05319873 | ACTIVE_NOT_RECRUITING | 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 |
Jonsson Comprehensive Cancer Center |
2022-04-07 | PHASE1; PHASE2 |
| NCT05673928 | RECRUITING | Metastatic Solid Tumor; Brain Metastases |
M.D. Anderson Cancer Center |
2023-05-16 | PHASE2 |
| NCT06983691 | NOT_YET_RECRUITING | HER2+ Metastatic Breast Cancer (MBC) |
Duke University |
2026-08 | |
| NCT03297606 | RECRUITING | Lymphoma, Non-Hodgkin; Multiple Myeloma; Advanced Solid Tumors |
Canadian Cancer Trials Group |
2018-03-23 | PHASE2 |
| NCT06016387 | RECRUITING | HER2-positive Breast Cancer; LMD |
Sunnybrook Health Sciences Centre |
2023-11-25 | PHASE2 |
| NCT06239467 | ACTIVE_NOT_RECRUITING | Advanced Cancer; Breast Cancer; Advanced Solid Tumors; PI3K Gene Mutation |
OnKure, Inc. |
2024-02-26 | PHASE1 |
| NCT05382364 | ACTIVE_NOT_RECRUITING | Metastatic HER2+ Advanced Breast Cancer; Breast Neoplasms; Gastric or Gastroesophageal Junction Adenocarcinoma (GEC); Colorectal Cancer |
Pfizer |
2022-06-29 | PHASE1 |
| NCT05800275 | RECRUITING | Leptomeningeal Metastasis; Leptomeningeal Disease; HER2-positive Metastatic Breast Cancer |
UNICANCER |
2023-12-18 | PHASE2 |
| NCT05323955 | ACTIVE_NOT_RECRUITING | Brain Metastases; Human Epidermal Growth Factor 2 Positive Carcinoma of Breast; Advanced Breast Cancer |
Carey Anders, M.D. |
2023-03-23 | PHASE2 |
| NCT06162559 | RECRUITING | Breast Cancer |
The Netherlands Cancer Institute |
2023-12-18 | PHASE1 |
| NCT05230810 | ACTIVE_NOT_RECRUITING | HER2-positive Metastatic Breast Cancer |
Criterium, Inc. |
2022-08-25 | PHASE1; PHASE2 |
| NCT05553522 | TERMINATED | Brain Metastases; HER2-positive Breast Cancer |
Baptist Health South Florida |
2024-01-29 | PHASE1 |
| NCT05132582 | ACTIVE_NOT_RECRUITING | HER2 Positive Breast Cancer |
Seagen, a wholly owned subsidiary of Pfizer |
2022-03-07 | PHASE3 |
| NCT04789096 | TERMINATED | Breast Cancer; HER2-positive Breast Cancer |
Breast Cancer Trials, Australia and New Zealand |
2023-03-07 | PHASE2 |
| NCT05583110 | TERMINATED | HER2-positive Metastatic Breast Cancer; Locally Advanced HER2 Positive Breast Carcinoma |
Spanish Breast Cancer Research Group |
2023-03-08 | PHASE2 |
| NCT05041842 | ACTIVE_NOT_RECRUITING | Metastatic Breast Cancer With a Isolated Brain Progression |
UNICANCER |
2021-12-17 | PHASE2 |
| NCT04538742 | ACTIVE_NOT_RECRUITING | Metastatic Breast Cancer |
AstraZeneca |
2020-12-28 | PHASE1; PHASE2 |
| NCT06067776 | NOT_YET_RECRUITING | Metastatic Lung Non-Small Cell Carcinoma; Recurrent Lung Non-Small Cell Carcinoma; Stage IV Lung Cancer AJCC v8 |
Jonathan Riess |
2024-01-01 | PHASE1 |
| NCT02892123 | COMPLETED | HER2-expressing Cancers |
Jazz Pharmaceuticals |
2016-09-30 | PHASE1 |
| NCT05227131 | WITHDRAWN | Metastatic Breast Cancer; Advanced Breast Cancer; HER2-positive Breast Cancer |
MedSIR |
2022-05-15 | PHASE2 |
| NCT05356897 | WITHDRAWN | Metastatic Colon Adenocarcinoma; Metastatic Colorectal Adenocarcinoma; Metastatic Rectal Adenocarcinoma; Stage IV Colon Cancer AJCC V8; Stage IV Colorectal Cancer AJCC V8; Stage IV Rectal Cancer AJCC V8 |
Academic and Community Cancer Research United |
2023-10-31 | PHASE2 |
| NCT04430738 | ACTIVE_NOT_RECRUITING | Colorectal Carcinoma; Gastric Adenocarcinoma; GEJ Adenocarcinoma; Esophageal Adenocarcinoma; Cholangiocarcinoma; Gallbladder Carcinoma |
Seagen, a wholly owned subsidiary of Pfizer |
2020-09-15 | PHASE2 |
| NCT04539938 | COMPLETED | HER2 Positive Breast Cancer |
Seagen, a wholly owned subsidiary of Pfizer |
2020-12-01 | PHASE2 |
| NCT04512261 | WITHDRAWN | Breast Cancer; Brain Metastases; HER2-positive Breast Cancer; CNS Disease |
Reva Basho |
2022-06-01 | PHASE1; PHASE2 |
| NCT04499924 | COMPLETED | Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma; Esophageal Adenocarcinoma |
Seagen Inc. |
2021-03-22 | PHASE2; PHASE3 |
| NCT05458674 | Recruiting | Breast Cancer |
Criterium Inc. |
2024-01-01 | Phase 2 |
| NCT04632992 | COMPLETED | Advanced Unresectable or Metastatic Solid Malignancy |
Genentech, Inc. |
2021-01-13 | PHASE2 |
| NCT04579380 | ACTIVE_NOT_RECRUITING | Uterine Neoplasms; Uterine Cervical Neoplasms; Biliary Tract Neoplasms; Urologic Neoplasms; Carcinoma, Non-Small-Cell Lung; HER2 Mutations Breast Neoplasms |
Seagen, a wholly owned subsidiary of Pfizer |
2021-01-11 | PHASE2 |
| NCT04721977 | ACTIVE_NOT_RECRUITING | Breast Cancer |
Pfizer |
2021-04-08 | PHASE2 |
| NCT05748834 | Recruiting | Breast Cancer |
SCRI Development Innovations LLC|Seagen Inc. |
2023-07-24 | Phase 2 |
| NCT03975647 | ACTIVE_NOT_RECRUITING | HER2-positive Breast Cancer |
Seagen, a wholly owned subsidiary of Pfizer |
2019-10-02 | PHASE3 |
| NCT04896320 | WITHDRAWN | Breast Cancer Stage IV |
Providence Health & Services |
2021-12-15 | PHASE1; PHASE2 |
| NCT05892068 | Recruiting | Metastatic Breast Cancer |
Memorial Sloan Kettering Cancer Center|Seagen Inc. |
2023-05-09 | Phase 2 |
| NCT05190445 | ACTIVE_NOT_RECRUITING | HER2-positive Gastric Cancer |
Pieris Pharmaceuticals, Inc. |
2021-11-01 | PHASE2 |
| NCT03054363 | COMPLETED | Breast Cancer |
University of Colorado, Denver |
2017-11-27 | PHASE1; PHASE2 |
| NCT05230810 | Recruiting | HER2-positive Metastatic Breast Cancer |
Criterium Inc.|Novartis|Seagen Inc. |
2022-08-25 | Phase 1|Phase 2 |
| NCT05091528 | TERMINATED | HER2-positive Breast Cancer; HER2-positive Gastric Cancer; HER2-positive Colorectal Cancer; HER2-expressing Non-small Cell Lung Cancer |
Silverback Therapeutics |
2022-02-08 | PHASE1; PHASE2 |
| NCT05382364 | Active not recruiting | Metastatic HER2+ Advanced Breast Cancer|Breast Neoplasms|Gastric or Gastroesophageal Junction Adenocarcinoma (GEC)|Colorectal Cancer |
Merck Sharp & Dohme LLC |
2022-06-29 | Phase 1 |
| NCT03043313 | COMPLETED | Metastatic Colorectal Adenocarcinoma |
Seagen Inc. |
2017-06-23 | PHASE2 |
| NCT03501979 | TERMINATED | Metastatic Breast Cancer; Leptomeningeal Disease |
University of Alabama at Birmingham |
2019-02-20 | PHASE2 |
| NCT03846583 | WITHDRAWN | Breast Cancer |
Dana-Farber Cancer Institute |
2020-06-28 | PHASE1 |
| NCT02614794 | COMPLETED | HER2 Positive Breast Cancer |
Seagen Inc. |
2016-01-28 | PHASE2 |
| NCT03914755 | COMPLETED | Healthy |
Seagen Inc. |
2019-05-08 | PHASE1 |
| NCT03722823 | COMPLETED | Hepatic Impairment |
Seagen Inc. |
2018-10-10 | PHASE1 |
| NCT03777761 | COMPLETED | Healthy |
Seagen Inc. |
2018-12-06 | PHASE1 |
| NCT03826602 | COMPLETED | Drug-drug Interaction |
Seagen Inc. |
2019-02-12 | PHASE1 |
| NCT03723395 | COMPLETED | Drug-drug Interaction |
Seagen Inc. |
2018-09-17 | PHASE1 |
| NCT03758339 | COMPLETED | Healthy |
Cascadian Therapeutics Inc. |
2017-12-30 | PHASE1 |
| NCT01983501 | COMPLETED | HER2 Positive Breast Cancers |
Seagen Inc. |
2014-02-28 | PHASE1 |
| NCT02025192 | COMPLETED | HER2 Positive Metastatic Breast Cancers |
Seagen Inc. |
2013-12-31 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2026-08-28)
Check the
Tucatinib (Irbinitinib, ONT-380, Arry-380)
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
- Tucatinib (Irbinitinib, ONT-380, Arry-380) Mechanism of Action: HER2 Inhibition in Breast Cancer Cell Research
- Tucatinib (Irbinitinib, ONT-380, Arry-380): Selectivity & Specificity
- Tucatinib (Irbinitinib, ONT-380, Arry-380) Working Concentration | Cell Culture | Treatment
- Tucatinib (Irbinitinib, ONT-380, Arry-380) Solubility in DMSO
- Tucatinib (Irbinitinib, ONT-380, Arry-380) Stock Solution
- Tucatinib (Irbinitinib, ONT-380, Arry-380) Storage
- Tucatinib (Irbinitinib, ONT-380, Arry-380) Stability
- Tucatinib (Irbinitinib, ONT-380, Arry-380) Combination Database
- Tucatinib (Irbinitinib, ONT-380, Arry-380) Molecular Weight
- Tucatinib (Irbinitinib, ONT-380, Arry-380) SMILES
- Tucatinib (Irbinitinib, ONT-380, Arry-380) CAS Number
- Tucatinib (Irbinitinib, ONT-380, Arry-380) Chemical Structure (2D and 3D)
- Tucatinib (Irbinitinib, ONT-380, Arry-380) IC50 for Cell-based and Cell-free Assays
- Tucatinib (Irbinitinib, ONT-380, Arry-380) Sigma (AMBH2D6FF9B0)? Try a better option.
- Tucatinib (Irbinitinib, ONT-380, Arry-380) MedChemExpress (HY-16069)? Try a better option.
- Tucatinib (Irbinitinib, ONT-380, Arry-380) Cayman (31411)? Try a better option.
- Tucatinib (Irbinitinib, ONT-380, Arry-380) APExBIO (C8917)? Try a better option.
- Tucatinib (Irbinitinib, ONT-380, Arry-380) SDS｜MSDS
Note: Technical data last updated: Sep 1, 2026.