Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AMG 410 · 1 trial · 1 indication
Clinically significant changes in safety assessments (vital signs, electrocardiograms \[ECGs\], and clinical laboratory tests) are to be reported as adverse events.
Clinically significant changes in safety assessments (vital signs, ECGs, and clinical laboratory tests) are to be reported as adverse events.
| Arm | Type | Description |
|---|---|---|
| Part 1: Monotherapy Dose Exploration | EXPERIMENTAL | Participants will receive escalating doses of AMG 410. |
| Part 1: Food Effect Substudy Cohort | EXPERIMENTAL | A food effect substudy will be conducted. During the substudy, participants will receive AMG 410 under fasted and fed conditions. |
| Part 1: China-specific Cohort | EXPERIMENTAL | Participants identified through regionally approved molecular KRAS testing will receive AMG 410. |
| Part 2: Monotherapy Dose Expansion | EXPERIMENTAL | Monotherapy dose expansion of AMG 410 may proceed in KRAS altered tumors in non-small cell lung cancer (NSCLC), colorectal cancer (CRC), pancreatic ductal adenocarcinoma (PDAC), and other KRAS altered tumor types. |
| Part 3a: Combination Therapy Dose Exploration and Dose Expansion | EXPERIMENTAL | Part 3a allows for AMG 410 dose exploration and expansion in combination with pembrolizumab in KRAS altered advanced or metastatic solid tumors. |
| Part 3b: Combination Therapy Dose Exploration and Dose Expansion | EXPERIMENTAL | Part 3b allows for AMG 410 dose exploration and expansion in combination with panitumumab in advanced or metastatic CRC and/or PDAC. |
| Name | Type | Description |
|---|---|---|
| AMG 410 | DRUG | Administered as an oral tablet. |
| Pembrolizumab | DRUG | Administered as an intravenous (IV) infusion. |
| Panitumumab | DRUG | Administered as an IV infusion. |
Inclusion Criteria: 1. Age ≥ 18 years (or \> legal age within the country if it is older than 18 years). 2. Pathologically documented, locally-advanced or metastatic malignancy with any missense mutation in the KRAS gene or evidence of KRAS amplification using an analytically validated KRASWT ampli...
AMG 410 is an investigational small molecule being developed for the treatment of KRAS altered advanced or metastatic solid tumors. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
AMG 410 is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug.
AMG 410 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and efficacy in patients.
AMG 410 is being studied in a Phase 1 clinical trial with the identifier NCT07094113. This trial is evaluating AMG 410 alone and in combination with other agents in participants with KRAS altered advanced or metastatic solid tumors. The trial is currently recruiting participants.
AMG 410 is a small molecule designed to target KRAS altered tumors. It is being studied for its potential to treat advanced or metastatic solid tumors that harbor KRAS alterations, which are genetic changes that can drive cancer growth.