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 by Amgen Inc. for KRAS altered advanced or metastatic solid tumors. It is a targeted oncology therapy that is biomarker selected, meaning it is intended for patients whose tumors carry alterations in KRAS. It is currently in Phase 1 clinical development.
AMG 410 is being studied for the treatment of KRAS altered advanced or metastatic solid tumors. The Phase 1 trial enrolls adults 18 years and older with these tumor types. Because the study is still in early clinical development, AMG 410 has not been established as a treatment option outside of a clinical trial setting.
AMG 410 targets KRAS, a signaling protein that is frequently altered in solid tumors. By acting on KRAS, AMG 410 is designed to address tumors that carry KRAS alterations. It is a small molecule therapeutic, and the Phase 1 study is restricted to patients whose tumors are KRAS altered.
AMG 410 is being developed by Amgen Inc., which trades on Nasdaq under the ticker AMGN. Amgen is the sponsor of the Phase 1 clinical program evaluating AMG 410 both as a single agent and in combination with other agents in patients with KRAS altered advanced or metastatic solid tumors.
AMG 410 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The single ongoing Phase 1 trial is currently recruiting participants and is designed to evaluate AMG 410 alone and in combination with other agents.
AMG 410 is being evaluated in one Phase 1 trial, NCT07094113, titled AMG 410 Alone and in Combination With Other Agents in Participants With KRAS Altered Advanced or Metastatic Solid Tumors. The trial is recruiting, has an estimated enrollment of 434 participants, and is open to all sexes aged 18 years and older across multiple countries.