Asset profile
Zanidatamab
Multispecific antibody
Approvedregulatory verdict
Evidence outlook
Approved: Biliary Tract Cancer
Regulatory approval supersedes design-level evidence grading; the trials behind approval are preserved below as the drug's evidence history.
Also in development:Non-Small Cell Lung Cancer · Phase 2
Also approved:US: ZIIHERA is indicated for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC). (product first approved 2024), outside this platform's coverageUS: ZIIHERA is a bispecific HER2-directed antibody indicated for: Gastroesophageal Adenocarcinoma (GEA) • in combination with fluoropyrimidine- and platinum-containing chemotherapy, and tislelizumab-jsgr, as first-line treatment of adult patients with HER2-positive (IHC 3+ or IHC 2+/ISH+) unresectable locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma, as detected by an FDA-authorized test. (product first approved 2024), outside this platform's coverage
Featured evidence outside covered markets:NCT06435429 · Metastatic HER2-positive Breast Cancer · Phase 3 · ungraded
How the evidence outlook works ↗
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
74 competitors in this universe: 12 direct rivals (same mechanism and indication), 1 same-class, 61 same-indication.
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| Drug | Stage | Modality | Mechanism | Evidence signal | Reported efficacygraded featured trials |
|---|---|---|---|---|---|
| Zanidatamab: this drug | Approved | Multispecific antibody | HER2 | ||
| Trastuzumab Deruxtecan | Approved | Antibody–drug conjugate | 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 | ||
| Tucatinib | Phase 3 | Small molecule | 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 59 more. Research shows the complete landscape.
Research
Unlock with Research ↗Unlock the full comparison
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
(22 total)
Estimated primary-completion dates from ClinicalTrials.gov. These are registry estimates, never confirmed readout dates; they can move as trials progress.
2026 (2)
2027 (3)
June 2027 (1)
Phase 3Biliary Tract NeoplasmsRecruiting
Est. primary completion 2027-06 · NCT05615818 · CT.gov ↗
What to watch
2028 (11)
January 2028 (1)
Phase 2HER2-positive Breast Cancer, Breast CancerRecruiting
Est. primary completion 2028-01-01 · NCT07102381 · CT.gov ↗
What to watch
March 2028 (1)
Phase 2Non-Small Cell Lung CancerRecruiting
Est. primary completion 2028-03-13 · NCT07192068 · CT.gov ↗
What to watch
April 2028 (1)
Phase 3Metastatic HER2-positive Breast CancerRecruiting
Est. primary completion 2028-04-28 · NCT06435429 · CT.gov ↗
What to watch
June 2028 (4)
Phase 1/2Gastroesophageal CancerNot yet recruiting
Est. primary completion 2028-06 · NCT07477444 · CT.gov ↗
What to watch
Phase 2Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, HER2-positive Gastric CancerNot yet recruiting
Est. primary completion 2028-06 · NCT07685704 · CT.gov ↗
What to watch
Phase 2Gastroesophageal AdenocarcinomaRecruiting
Est. primary completion 2028-06-01 · NCT07290985 · CT.gov ↗
What to watch
Phase 2Gastric/Gastroesophageal Junction AdenocarcinomaNot yet recruiting
Est. primary completion 2028-06-30 · NCT07273981 · CT.gov ↗
What to watch
July 2028 (1)
Phase 2Locally Advanced Rectal Cancer (LARC), Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma …Not yet recruiting
Est. primary completion 2028-07-30 · NCT07243938 · CT.gov ↗
What to watch
December 2028 (3)
Phase 3Biliary Tract CancerRecruiting
Est. primary completion 2028-12-01 · NCT06282575 · CT.gov ↗
What to watch
Phase 2Colon Carcinoma, Colorectal Carcinoma, Rectal Carcinoma, Stage I Colon Cancer AJCC v8, Stage I Colorectal Cancer AJCC v8 …Recruiting
Est. primary completion 2028-12-18 · NCT07405476 · CT.gov ↗
What to watch
Phase 2Breast Cancer, HER2-positiveRecruiting
Est. primary completion 2028-12-29 · NCT05035836 · CT.gov ↗
What to watch
2029 (3)
January 2029 (1)
Phase 1/2Metastatic Breast Cancer, Metastatic Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Esophageal Adenocarcinoma …Recruiting
Est. primary completion 2029-01-08 · NCT06324357 · CT.gov ↗
What to watch
March 2029 (1)
Phase 2Gastroesophageal Adenocarcinoma, First Line Therapy, HER2 + Gastric Cancer, PDL-1, MetastasesRecruiting
Est. primary completion 2029-03 · NCT07176312 · CT.gov ↗
What to watch
December 2029 (1)
Phase 2Neoplasms, Solid Tumors, HER2 Positive Solid Tumor, Endometrial Neoplasm, Urothelial Carcinoma (UC), Pancreatic Neoplasms …Not yet recruiting
Est. primary completion 2029-12-31 · NCT07631871 · CT.gov ↗
What to watch
2030 (2)
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
2033 (1)
July 2033 (1)
Phase 3Biliary Tract CancerNot yet recruiting
Est. primary completion 2033-07-02 · NCT07745296 · 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.