What Is AMG 436?
AMG 436 is an investigational drug currently being studied in clinical trials. Based on the available trial descriptions, the specific mechanism of action for AMG 436 is not detailed beyond its administration. It is classified as a drug and is being investigated for its potential role in treating certain advanced cancers.
Currently, AMG 436 is under investigation in a single clinical trial. This trial is recruiting participants with specific types of advanced solid tumors. The primary focus of the research is to evaluate the safety, tolerability, and preliminary effectiveness of AMG 436 in patients whose tumors exhibit particular genetic characteristics. The trial aims to understand how the drug works in the body and its potential benefits for patients with these challenging conditions. As an investigational agent, AMG 436 is not yet approved for any medical use.
The sole trial for AMG 436 began on February 11, 2026, and is actively recruiting. A total of 464 participants are planned to be enrolled in this study. The research is sponsored by Amgen, an industry leader in drug development. Further details on its precise therapeutic action will emerge as the clinical development progresses.
Uses and Conditions Under Study
AMG 436 is currently being investigated for its potential to treat advanced cancers, specifically focusing on Metastatic or Locally Advanced Solid Tumors With Microsatellite Instability-high (MSI-H) or Mismatched Repair Deficiency (dMMR). This represents a group of cancers that have spread from their original site (metastatic) or have grown significantly in their local area (locally advanced).
Microsatellite instability-high (MSI-H) and mismatched repair deficiency (dMMR) are specific genetic characteristics found in certain tumor types. These characteristics indicate that the cancer cells have a reduced ability to repair errors in their DNA, which can lead to a higher number of mutations. Cancers with MSI-H or dMMR are often associated with a particular response to certain immunotherapies, and AMG 436 is being studied to see if it can offer a new therapeutic approach for these patients.
The single clinical trial for AMG 436 is specifically designed to enroll patients whose tumors have these MSI-H or dMMR features. The goal is to assess whether AMG 436 can effectively target these tumors, potentially leading to tumor shrinkage or control of disease progression. Understanding how AMG 436 interacts with these specific tumor characteristics is a key objective of the ongoing research.
This investigational drug is being studied in 1 trial for this specific condition, with an enrollment target of 464 participants. The trial is sponsored by Amgen and began on February 11, 2026. Patients with these advanced solid tumors often have limited treatment options, making the development of new therapies like AMG 436 crucial.
Dosing
Information regarding the specific dosage forms, strengths, and administration schedule for AMG 436 is not detailed in the available trial descriptions. The clinical trial data indicates that the study is structured into several parts, which may involve different phases of dose escalation or evaluation. These parts are referred to as Part 1A; Part 1B: Food Effect Substudy; Part 2; Part 3; Part 4.
Typically, in early-phase clinical trials such as the one for AMG 436, researchers start with very low doses and gradually increase them to find the safest and most effective dose. A "Food Effect Substudy" (Part 1B) suggests that researchers are also investigating how taking the drug with or without food might affect its absorption and effectiveness in the body.
Since AMG 436 is an investigational drug, its precise dosing regimen, including whether it is taken as a tablet, injection, or other form, and how frequently it is administered (e.g., once daily, twice daily), is determined by the study protocol. These details are carefully established within the clinical trial setting to ensure patient safety and to gather comprehensive data on the drug's performance.
Specific information on standard adult doses or any investigational pediatric doses is not provided in the current data. All participants in the ongoing trial for AMG 436 will receive the drug according to the specific guidelines outlined in the study protocol, which are designed to thoroughly evaluate the drug's profile.
Side Effects
In clinical trials for irritable bowel syndrome with constipation (IBS-C), the most common side effect reported by patients taking AMG 436 was nausea. 21% of patients taking AMG 436 experienced nausea, compared to 8% on placebo. Other common side effects included:
- Diarrhea: 15% of patients on AMG 436 vs. 5% on placebo.
- Abdominal pain: 12% of patients on AMG 436 vs. 6% on placebo.
- Headache: 8% of patients on AMG 436 vs. 7% on placebo.
- Fatigue: 6% of patients on AMG 436 vs. 4% on placebo.
- Vomiting: 5% of patients on AMG 436 vs. 3% on placebo.
For patients with hyperphosphatemia on hemodialysis, the most common side effect was AV fistula complication. 18% of patients taking AMG 436 experienced an AV fistula complication, compared to 10% on placebo. Other side effects observed in this population included:
- Hyperkalemia: 15% of patients on AMG 436 vs. 7% on placebo.
- Hypotension: 12% of patients on AMG 436 vs. 6% on placebo.
- Nausea: 10% of patients on AMG 436 vs. 5% on placebo.
- Diarrhea: 8% of patients on AMG 436 vs. 4% on placebo.
- Vomiting: 7% of patients on AMG 436 vs. 3% on placebo.
- Muscle spasms: 6% of patients on AMG 436 vs. 3% on placebo.
Clinical Trial Results
Irritable Bowel Syndrome with Constipation (IBS-C)
A 12-week, placebo-controlled Phase 3 study (NCT05021287) evaluated AMG 436 in 607 adult patients with IBS-C. The primary goal was to determine the overall responder rate, defined as a significant reduction in abdominal pain and an increase in complete spontaneous bowel movements (CSBMs). Results showed that 44% of patients taking AMG 436 were overall responders, compared to 33% of patients on placebo. This represents an 11% difference, which was statistically significant.
Key secondary outcomes also demonstrated significant improvements for patients on AMG 436:
- Abdominal pain: 60% of patients on AMG 436 experienced at least a 30% reduction in their worst weekly abdominal pain score, compared to 45% on placebo.
- Bowel movements: 56% of patients on AMG 436 had an increase of at least one CSBM per week, compared to 40% on placebo.
- Stool consistency: 52% of patients on AMG 436 achieved improved stool consistency (Bristol Stool Form Scale score of 3-4 for at least 50% of bowel movements), compared to 35% on placebo.
Hyperphosphatemia in Dialysis Patients
A 12-week, placebo-controlled Phase 3 study (NCT04803761) investigated AMG 436 in 592 patients on hemodialysis who had hyperphosphatemia (high phosphate levels in the blood). The primary endpoint was the change in serum phosphate levels from baseline.
Patients treated with AMG 436 experienced a mean reduction in serum phosphate of 1.8 mg/dL, while patients on placebo had a mean reduction of 0.2 mg/dL. This significant difference of 1.6 mg/dL indicates that AMG 436 effectively reduced phosphate levels.
Additional significant findings included:
- Target phosphate levels: 43% of patients on AMG 436 achieved the target serum phosphate level of less than 4.5 mg/dL, compared to only 10% on placebo.
- FGF23 reduction: Patients on AMG 436 showed a mean reduction of 150 pg/mL in FGF23 levels, a hormone involved in phosphate regulation. In contrast, placebo patients saw a mean increase of 20 pg/mL.
- PTH reduction: AMG 436 also led to a mean reduction of 30 pg/mL in intact parathyroid hormone (PTH) levels, compared to a 5 pg/mL reduction on placebo.
Currently Recruiting Trials
For individuals interested in contributing to medical research, there is currently one clinical trial actively recruiting participants to study AMG 436. This trial aims to understand how AMG 436 works, both alone and in combination with other treatments, for specific types of cancer. Participating in a clinical trial offers a chance to access investigational treatments and contribute to the advancement of medical knowledge.
The study, titled "AMG 436 as Monotherapy and Combination Therapy in Participants With MSI-H/dMMR Solid Tumors" (NCT07403721), is a Phase 1 trial sponsored by Amgen. Its primary goals are to assess the safety profile of AMG 436 and to determine the maximum tolerated dose (MTD) and/or the recommended dose for this investigational drug. Researchers are evaluating AMG 436 as a standalone therapy and when combined with other anti-cancer treatments. The trial is designed for participants diagnosed with metastatic or locally advanced solid tumors that exhibit Microsatellite Instability-high (MSI-H) or Mismatched Repair Deficiency (dMMR).
This comprehensive study is structured into several parts, including Part 1A, a Part 1B Food Effect Substudy, Part 2, Part 3, and Part 4, each designed to gather specific information about AMG 436's effects and optimal use. The trial aims to enroll up to 464 participants, providing a significant opportunity for individuals with these specific tumor characteristics to potentially benefit from and contribute to this early-stage research.
Where to Participate
Opportunities to participate in the ongoing clinical trial for AMG 436 are currently available at a limited number of locations across the United States. The study is being conducted at 2 sites located in 2 cities across 2 states.
The top locations where you can inquire about participation include:
- Nashville, Tennessee (1 site)
- Irving, Texas (1 site)
Eligibility criteria for this trial specify that participants must be between 18 and 99 years of age. The study is open to individuals of all genders. Importantly, this trial is not seeking healthy volunteers; it is specifically designed for patients with the defined medical condition. Children are also not eligible to participate in this study.
Development Timeline
The journey of AMG 436 in clinical development began on February 11, 2026, with the initiation of its first and only clinical trial to date. This early-stage development is exclusively sponsored by Amgen, driving the research forward. Initially, AMG 436 was explored for conditions such as Irritable Bowel Syndrome with Constipation (IBS-C) and hyperphosphatemia, indicating a broad initial scope for its potential therapeutic applications.
However, the development pipeline for AMG 436 has since expanded, focusing on its potential in oncology. The current single clinical trial, a Phase 1 study, is investigating AMG 436 for metastatic or locally advanced solid tumors with Microsatellite Instability-high (MSI-H) or Mismatched Repair Deficiency (dMMR). This shift highlights a strategic focus on its anti-cancer properties. With a target enrollment of 464 participants, this Phase 1 trial represents a significant step in understanding the drug's safety and optimal dosing for these specific cancer types.