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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-524056-63-00 | Other Identifier | EU CT Number |
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The primary objectives of this trial are to evaluate the safety profile of AMG 436 and to determine the maximum tolerated dose (MTD) and/or the recommended dose for AMG 436 as monotherapy and in combination with other anti-cancer therapies in participants with MSI-H/dMMR solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1A | Experimental | AMG 436 monotherapy dose escalation. |
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| Part 1B: Food Effect Substudy | Experimental | Participants will receive AMG 436 under fasted and fed conditions (United States only). |
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| Part 2 | Experimental | AMG 436 + combination dose escalation. |
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| Part 3 | Experimental | AMG 436 monotherapy Dose expansion and optimization. |
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| Part 4 | Experimental | AMG 436 + chemotherapy combination dose expansions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 436 | Drug | AMG 436 will be administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with a Dose Limiting Toxicity (DLT) | Up to 21 days | |
| Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Serum Concentration (Cmax) of AMG 436 | Up to 57 days | |
| Minimum Serum Concentration (Cmin) of AMG 436 | Up to 57 days | |
| Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of AMG 436 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amgen Call Center | Contact | 866-572-6436 | medinfo@amgen.com |
| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Orange County Lennar Foundation Cancer Center | Recruiting | Irvine | California | 92618 | United States | |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Data sharing requests relating to this trial will be considered beginning 18 months after the trial has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this trial.
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen trial/trials in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
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| Up to 57 days |
| Time to Achieve Cmax (Tmax) of AMG 436 | Up to 57 days |
| Part 1B: Cmax of AMG 436 in the Fed and/or Fasted State | Up to 24 days |
| Part 1B: Tmax of AMG 436 in the Fed and/or Fasted State | Up to 24 days |
| Part 1B: AUC Over the Dosing Interval of AMG 436 in the Fed and/or Fasted State | Up to 24 days |
| Confirmed Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Up to 5 years |
| Duration of Response (DOR) per RECIST v1.1 | Up to 5 years |
| Time to Response (TTR) per RECIST v1.1 | Up to 5 years |
| Disease Control Rate (DCR) per RECIST v1.1 | Up to 5 years |
| Progression-free Survival (PFS) per RECIST v1.1 | Up to 5 years |
| Overall Survival (OS) per RECIST v1.1 | Up to 5 years |
| Change From Baseline in Tumor Phosphorylated Checkpoint Kinase 2 (CHK2) Following AMG 436 | Baseline up to 5 years |
| Midwestern Regional Medical Center dba City of Hope Chicago |
| Recruiting |
| Zion |
| Illinois |
| 60099 |
| United States |
| New England Cancer Specialists | Recruiting | Westbrook | Maine | 04092 | United States |
| Tennessee Oncology PLLC | Recruiting | Nashville | Tennessee | 37203 | United States |
| Next Oncology - Dallas | Recruiting | Irving | Texas | 75039 | United States |
| Calvary Mater Newcastle Hospital | Recruiting | Waratah | New South Wales | 2298 | Australia |
| Peter MacCallum Cancer Centre | Recruiting | Melbourne | Victoria | 3000 | Australia |
| Universite Catholique de Louvain Cliniques Universitaires Saint Luc | Recruiting | Brussels | 1200 | Belgium |
| Universitair Ziekenhuis Gent | Recruiting | Ghent | 9000 | Belgium |
| Princess Margaret Cancer Centre | Recruiting | Toronto | Ontario | M5G 1Z5 | Canada |
| Sun Yat-Sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510663 | China |
| Zhongshan Hospital Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
| Hopital Saint Antoine | Recruiting | Paris | 75012 | France |
| Gustave Roussy | Recruiting | Villejuif | 94805 | France |
| Aichi Cancer Center | Recruiting | Nagoya | Aichi-ken | 464-8681 | Japan |
| National Cancer Center Hospital East | Recruiting | Kashiwa-shi | Chiba | 277-8577 | Japan |
| National Cancer Center Hospital | Recruiting | Chuo-ku | Tokyo | 104-0045 | Japan |
| The Cancer Institute Hospital of Japanese Foundation for Cancer Research | Recruiting | Koto-ku | Tokyo | 135-8550 | Japan |
| Hospital Clinic i Provincial de Barcelona | Recruiting | Barcelona | Catalonia | 08036 | Spain |
| Clinica Universidad de Navarra | Recruiting | Madrid | 28027 | Spain |
| Taipei Veterans General Hospital | Recruiting | Taipei | 11217 | Taiwan |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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