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| Therapy Name | IAM1363 + Trastuzumab deruxtecan |
| Synonyms | |
| Therapy Description | |
| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| IAM1363 | IAM-H1|ENT-H1 | HER2 Inhibitor 45 | IAM1363 irreversibly inhibits wild-type and mutant ERBB2 (HER2), including exon 20 insertions, potentially leading to tumor growth inhibition (Cancer Res (2023) 83 (7_Supplement): 4034). | |
| Trastuzumab deruxtecan | Enhertu | DS-8201|DS8201a|T-DXd|DS-8201|fam-trastuzumab deruxtecan-nxki|DS-8201a | HER2 (ERBB2) Antibody 80 HER2 (ERBB2) Antibody-Drug Conjugate 36 | Enhertu (trastuzumab deruxtecan) is an antibody-drug conjugate (ADC) comprising an anti-ERBB2 (HER2) antibody linked to a derivative of the topoisomerase inhibitor DX-8951, which delivers the cytotoxic agent to ERBB2 (HER2)-expressing tumor cells, potentially resulting in decreased growth of tumors, including tumors with low ERBB2 (HER2) expression (PMID: 27026201). Enhertu (fam-trastuzumab deruxtecan-nxki) is FDA approved for use in patients with ERBB2 (HER2)-positive breast cancer who have received two or more anti-HER2 therapies previously, in patients with ERBB2 (HER2)-low (IHC 1+ or IHC 2+/ISH -) breast cancer received prior chemotherapy, in patients with ERBB2 (HER2)-low or untra-low (IHC 0 with membrane staining) hormone receptor-positive breast cancer who had received endocrine therapy, in patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal (GEJ) adenocarcinoma who have received prior trastuzumab-based therapy, in patients with non-small cell lung cancer harboring ERBB2 (HER2) activating mutations who have received prior systemic therapy, in patients with ERBB2 (HER2)-positive (IHC 3+) solid tumors who have received prior systemic therapy, and in combination with Perjeta (pertuzumab) in patients with ERBB2 (HER2)-positive breast cancer (FDA.gov). |
| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|
| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT06253871 | Phase I | IAM1363 IAM1363 + Pembrolizumab Carboplatin + IAM1363 + Pembrolizumab + Pemetrexed Disodium Capecitabine + IAM1363 + Trastuzumab Capecitabine + IAM1363 + Zanidatamab IAM1363 + Trastuzumab deruxtecan | A Phase 1/1b Study of IAM1363 in HER2 Cancers | Recruiting | USA | NLD | ITA | IRL | GBR | FRA | ESP | 1 |