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New treatment option for HER2 Mutation-Related Tumors
Official title A Phase 1/1b Study of IAM1363 in HER2 Cancers
ClinicalTrials.gov ID: NCT06253871
What this study is testing
What is IAM1363?
IAM1363 is an investigational medicine, being studied as a potential treatment for her2 mutation-related 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 is a Phase 1/1b open-label, multi-center dose escalation and dose optimization study designed to evaluate the safety and preliminary efficacy of IAM1363 in participants with advanced cancers that harbor HER2 alterations.
- 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
- Have relapsed/refractory HER2-altered malignancy; for selected cohorts, prospective confirmation of HER2 alteration by central testing is required
- Have progression of disease after the last systemic therapy, or be intolerant of last systemic therapy
- Have radiographically measurable disease by RECIST v1.1 and/or RANO-BM
- Eastern Cooperative Oncology Group (ECOG) performance score 0-1
You likely can't join if
- Clinically significant cardiac disease
- Infection with human immunodeficiency virus (HIV)-1 or HIV-2. Exception: Participants with well-controlled HIV (e.g., CD4 \>350/mm3 and undetectable...
- Current active liver disease including hepatitis A, hepatitis B , or hepatitis C
- Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant small bowel resection that would preclude adequate absorption
- Uncontrolled diabetes
- History of solid organ transplantation
See the full eligibility criteria
- Age ≥ 18 years
- Have relapsed/refractory HER2-altered malignancy; for selected cohorts, prospective confirmation of HER2 alteration by central testing is required
- Have progression of disease after the last systemic therapy, or be intolerant of last systemic therapy
- Have radiographically measurable disease by RECIST v1.1 and/or RANO-BM
- Eastern Cooperative Oncology Group (ECOG) performance score 0-1
- Have adequate baseline hematologic, liver and renal function
- Have left ventricular ejection fraction (LVEF) ≥ 50%
- Able to swallow oral medication Key
- Clinically significant cardiac disease
- Infection with human immunodeficiency virus (HIV)-1 or HIV-2. Exception: Participants with well-controlled HIV (e.g., CD4 \>350/mm3 and undetectable viral load) are eligible
- Current active liver disease including hepatitis A, hepatitis B , or hepatitis C
- Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant small bowel resection that would preclude adequate absorption
- Uncontrolled diabetes
- History of solid organ transplantation
- History of Grade ≥2 CNS hemorrhage, or any CNS hemorrhage within 28 days before C1D1
- Prior history of non-infectious interstitial lung disease (ILD). (Exceptions: participants with prior grade 1 ILD that has completely resolved are eligible)
- Participants requiring immediate local therapy for brain metastases
The study team makes the final eligibility decision.
Where it's taking place
- La Jolla, California, United States
- Los Angeles, California, United States
- Aurora, Colorado, United States
- Miami, Florida, United States
- St. Petersburg, Florida, United States
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Detroit, Michigan, United States
- Grand Rapids, Michigan, United States
- Kansas City, Missouri, United States
- St Louis, Missouri, United States
- Lebanon, New Hampshire, United States
- New Brunswick, New Jersey, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Cleveland, Ohio, United States
- Oklahoma City, Oklahoma, United States
- Portland, Oregon, United States
- Nashville, Tennessee, United States
+ 25 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include La Jolla, California, United States; Los Angeles, California, United States; Aurora, Colorado, United States; Miami, Florida, United States; St. Petersburg, Florida, United States; Chicago, Illinois, United States and 39 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.