Phase 1/1b Study of IAM1363 for HER2-Altered Cancers
This study is testing a new drug called IAM1363 for people with advanced cancers that have changes in a protein called HER2. This includes HER2-positive breast cancer and other HER2-altered tumors, even those that have spread to the brain. Researchers want to see how safe IAM1363 is and if it helps shrink tumors. You might receive IAM1363 alone or in combination with other approved cancer medicines like capecitabine, trastuzumab, zanidatamab, T-Dxd, or pembrolizumab (sometimes with carboplatin and pemetrexed). To join, your cancer must have a HER2 alteration, have progressed after previous treatments, and be measurable on scans. The study will look at side effects and how the drug moves through your body.
- Study design
- This is a Phase 1/1b study, meaning it's an early-stage study to find the right dose and check for safety, and it is open-label, so you and your doctors will know which treatment you are receiving. It plans to enroll up to 383 participants across multiple centers.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your health will be monitored for side effects for up to 30 days after your last dose of study drug, and drug levels in your body will be measured for up to 42 days.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Phase 1/1b Study of IAM1363 in HER2 Cancers
At a glance
Conditions
Where it's being run
53 sites across 27 statesStudy leadership
- Iambic Therapeutics, Inc., Senior Medical Director · STUDY_DIRECTOR · Iambic Therapeutics, Inc
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Incidence and severity of dose limiting toxicities (DLTs) (Part 1 only)21 days
Incidence and severity of DLTs during the first cycle of treatment in participants in Part 1
- Incidence and severity of adverse events (AEs)Through 30 days after the last dose of study drug
Incidence of treatment emergent AEs (TEAEs) and serious adverse events (SAEs)
- Pharmacokinetic (PK) parametersUp to 42 days
PK parameters. Includes but is not limited to assessment of maximum concentration (Cmax).
- Confirmed objective response rate (cORR)Through study completion, estimated as 46 months
Percentage of participants who achieve a confirmed objective response (complete response \[CR\] + partial response \[PR\]) per the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
- Confirmed central nervous system ORR (CNS-cORR)Through study completion, estimated as 46 months
Percentage of participants who achieve a confirmed CNS-cORR (CNS-CR + CNS-PR) per the Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) Criteria
- Frequency of IAM1363 dose modifications, including treatment discontinuationsThrough 30 days after the last dose of study drug
- Incidence and severity of clinical laboratory abnormalitiesThrough 30 days post last dose of study drug
- Incidence of ECG abnormalitiesThrough 30 days after the last dose of study drug
As measured using standard ECG parameters, including pulse rate, QT intervals, and QRS duration.