Drugs / IAM1363
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT06253871 | Mar 2024 → Dec 2027 expected | HER2 positive breast carcinoma, gastroesophageal cancer, metastatic malignant neoplasm in the brain, non-small cell lung carcinoma +1 | Iambic Therapeutics, Inc | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2025-10-20 | Iambic Therapeutics, Inc | Results Iambic Shares Clinical Data from Ph1/1B Study of IAM1363, a Highly Selective Type-2 HER2 Inhibitor, Demonstrating Monotherapy Activity in Heavily Pretreated Patients with HER2 Alterations, at the 2025 ESMO Congress iambic.ai ↗
Iambic Therapeutics, a clinical-stage life science and technology company developing novel medicines using its AI-driven discovery and development platform, today announced clinical data for IAM1363, a brain-penetrant HER2 small-molecule tyrosine kinase inhibitor (TKI), which showed anti-tumor activity in heavily pretreated patients across multiple disease types, encompassing HER2-amplified, HER2-overexpressing, and HER2-mutant tumors. |
| 2025-09-03 | Iambic Therapeutics, Inc | Results Iambic to Present New Pre-Clinical NSCLC Data for IAM1363, a Selective Type II Inhibitor for HER2 Cancers, at the 2025 World Conference on Lung Cancer iambic.ai ↗
New IAM1363 data show potent anti-tumor activity and significant tumor regression across a panel of HER2-amplified and HER2-mutant NSCLC models, including greater anti-tumor activity compared to currently approved therapies. |
| 2024-03-28 | Iambic Therapeutics, Inc | Results Iambic Therapeutics to Present New Pre-Clinical Data for IAM1363, a Selective and Brain-Penetrant Inhibitor of both HER2 Wild-Type and Oncogenic Mutants, at the 2024 AACR Annual Meeting iambic.ai ↗
The poster presentation will showcase preclinical data illustrating how the unique binding mechanism and potent HER2 activity of IAM1363 overcomes multiple resistance mechanisms and how its strong EGFR avoidance widens the safety margin. |
| 2023-12-22 | Iambic Therapeutics, Inc | Regulatory Iambic Therapeutics Marks a Key Milestone in Advancing Cancer Treatment: IND Submission for IAM1363, a Selective, Brain-Penetrant HER2 Inhibitor iambic.ai ↗
Iambic Therapeutics, a biotechnology company developing novel therapeutics using its unique generative AI discovery platform, today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to initiate a Phase 1 clinical study evaluating IAM1363, a selective and brain-penetrant inhibitor of HER2 signaling for the treatment of HER2-driven solid tumors. |
All press releases naming this drug 8 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | IAM1363 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06253871 ↗ |
| Route | Oral | “Treatment with IAM1363 capsules, dosed orally alone or in combination with other anti-cancer agents, in 14- or 21-day cycles.” NCT06253871 ↗ |