Clinical trial for KRAS Altered Advanced or Metastatic Solid Tumors
Official title AMG 410 Alone and in Combination With Other Agents in Participants With KRAS Altered Advanced or Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT07094113
What this study is testing
What is AMG 410?
AMG 410 is an investigational medicine, taken by mouth, being studied as a potential treatment for kras altered advanced or metastatic solid tumors.
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
- This study aims to find the safest and most effective dose of AMG 410, either alone or with other treatments, for these cancers.
- Who it's for
- Adults with advanced or metastatic solid tumors that have a KRAS gene alteration.
- What's involved
- Participants will receive AMG 410, possibly with other drugs, and undergo regular tests to check how their body handles the medicine and how the cancer responds.
- Time commitment
- The study involves multiple visits to determine the right dose, followed by longer treatment periods for those who continue.
- 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 and older
You may be able to join if
- Age ≥ 18 years (or \> legal age within the country if it is older than 18 years).
- Pathologically documented, locally-advanced or metastatic malignancy with any missense mutation in the KRAS gene or evidence of KRAS amplification...
- Participants must have no standard of care treatment options or have actively refused such therapy.
- Able to swallow and retain per oral administered study treatment.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
You likely can't join if
- Untreated symptomatic central nervous system or leptomeningeal metastases.
- Uncontrolled pleural effusion and/or ascites.
- History of other malignancy within the past 5 years.
- Active systemic infection or symptoms that indicate an acute and/or uncontrolled infection requiring IV antibiotics within 7days prior to the first...
- History of arterial or venous thrombosis (eg, stroke, transient ischemic attack, pulmonary embolism, or deep vein thrombosis).
- Live and live-attenuated vaccines are prohibited within 28 days prior to the first dose of study treatment.
See the full eligibility criteria
- Age ≥ 18 years (or \> legal age within the country if it is older than 18 years).
- 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 amplification assay.
- Participants must have no standard of care treatment options or have actively refused such therapy.
- Able to swallow and retain per oral administered study treatment.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Disease measurable as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), as determined by the site investigator.
- Adequate organ function.
- Archival (formalin-fixed, paraffin-embedded [FFPE]) tumor tissue or block collected within 5 years before screening must be available.
- Untreated symptomatic central nervous system or leptomeningeal metastases.
- Uncontrolled pleural effusion and/or ascites.
- History of other malignancy within the past 5 years.
- Active systemic infection or symptoms that indicate an acute and/or uncontrolled infection requiring IV antibiotics within 7days prior to the first dose of study treatment.
- History of arterial or venous thrombosis (eg, stroke, transient ischemic attack, pulmonary embolism, or deep vein thrombosis).
- Live and live-attenuated vaccines are prohibited within 28 days prior to the first dose of study treatment.
- History of solid organ transplant.
- Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, hormonal therapy, or investigational agent) within 28 days of first dose of study treatment.
- Presence or history of any of the following viral infections: HIV, Hepatitis C, Hepatitis B, and active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
- Toxicities from prior anti-tumor therapy (including radiotherapy) not having improved to at least Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 1.
- Therapeutic or palliative radiation therapy within 2 weeks of first dose of study treatment.
- Major surgery within 28 days of first dose of study treatment.
- History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator, would pose a risk to participant safety.
The study team makes the final eligibility decision.
Where it is enrolling
- Duarte, California, United States
- Los Angeles, California, United States
- Atlanta, Georgia, United States
- Boston, Massachusetts, United States
- St Louis, Missouri, United States
- Durham, North Carolina, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
- San Antonio, Texas, United States
- Fairfax, Virginia, United States
- Camperdown, New South Wales, Australia
- Woodville South, South Australia, Australia
- Melbourne, Victoria, Australia
- Edegem, Belgium
- Ghent, Belgium
- Edmonton, Alberta, Canada
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
+ 17 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, but 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Duarte, California, United States; Los Angeles, California, United States; Atlanta, Georgia, United States; Boston, Massachusetts, United States; St Louis, Missouri, United States; Durham, North Carolina, United States and 31 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.