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New treatment option for Metastatic or Locally Advanced Solid Tumors With Microsatellite...
Official title AMG 436 as Monotherapy and Combination Therapy in Participants With MSI-H/dMMR Solid Tumors
ClinicalTrials.gov ID: NCT07403721
What this study is testing
What is AMG 436?
AMG 436 is an investigational medicine, being studied as a potential treatment for metastatic or locally advanced solid tumors with microsatellite instability-high (msi-h) or mismatched repair deficiency (dmmr).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years).
- Histologically confirmed MSI-H or dMMR metastatic or locally advanced solid tumor by local testing or central testing.
- Tumor tissue (formalin-fixed, paraffin-embedded sample) archival block must be available. Participants without archived tumor tissue may enroll by...
- Disease measurable as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
- Eastern Cooperative Oncology Group performance (ECOG) 0-1.
You likely can't join if
- Participants with primary central nervous system (CNS) tumors.
- Impaired cardiac function or clinically significant cardiac disease.
- Major surgery within 28 days of trial day 1.
- Antitumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, hormonal therapy, or investigational agent) within 21 days of first...
- Radiation therapy within 28 days of the first dose of trial treatment (or local or focal radiotherapy with palliative intent within 14 days of the...
- Gastrointestinal tract disease causing the inability to take per os (PO) medication, malabsorption syndrome, requirement for intravenous (IV)...
See the full eligibility criteria
- Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years).
- Histologically confirmed MSI-H or dMMR metastatic or locally advanced solid tumor by local testing or central testing.
- Tumor tissue (formalin-fixed, paraffin-embedded sample) archival block must be available. Participants without archived tumor tissue may enroll by undergoing tumor biopsy before dosing.
- Disease measurable as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
- Eastern Cooperative Oncology Group performance (ECOG) 0-1.
- Adequate organ function as defined in the protocol.
- Participants with primary central nervous system (CNS) tumors.
- Impaired cardiac function or clinically significant cardiac disease.
- Major surgery within 28 days of trial day 1.
- Antitumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, hormonal therapy, or investigational agent) within 21 days of first dose of trial treatment, unless anti-tumor therapy is a therapy with 5...
- Radiation therapy within 28 days of the first dose of trial treatment (or local or focal radiotherapy with palliative intent within 14 days of the first dose).
- Gastrointestinal tract disease causing the inability to take per os (PO) medication, malabsorption syndrome, requirement for intravenous (IV) alimentation, uncontrolled inflammatory gastrointestinal disease (eg, Crohn's...
The study team makes the final eligibility decision.
Where it's taking place
- Irvine, California, United States
- Zion, Illinois, United States
- Westbrook, Maine, United States
- Nashville, Tennessee, United States
- Irving, Texas, United States
- Waratah, New South Wales, Australia
- Melbourne, Victoria, Australia
- Brussels, Belgium
- Ghent, Belgium
- Toronto, Ontario, Canada
- Guangzhou, Guangdong, China
- Shanghai, Shanghai Municipality, China
- Paris, France
- Villejuif, France
- Nagoya, Aichi-ken, Japan
- Kashiwa-shi, Chiba, Japan
- Chuo-ku, Tokyo, Japan
- Koto-ku, Tokyo, Japan
- Barcelona, Catalonia, Spain
- Madrid, Spain
+ 1 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Irvine, California, United States; Zion, Illinois, United States; Westbrook, Maine, United States; Nashville, Tennessee, United States; Irving, Texas, United States; Waratah, New South Wales, Australia and 15 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.