NCT06253871 A Phase 1/1b Study of IAM1363 in HER2 Cancers
| NCT ID | NCT06253871 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Iambic Therapeutics, Inc |
| Condition | HER2 Mutation-Related Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 383 participants |
| Start Date | 2024-03-25 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 383 participants in total. It began in 2024-03-25 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Key Inclusion 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 Exclusion Criteria: * 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
Contact & Investigator
Iambic Therapeutics, Inc., Senior Medical Director
STUDY DIRECTOR
Iambic Therapeutics, Inc
Frequently Asked Questions
Who can join the NCT06253871 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying HER2 Mutation-Related Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06253871 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06253871 currently recruiting?
Yes, NCT06253871 is actively recruiting participants. Contact the research team at ClinicalTrials@Iambic.ai for enrollment information.
Where is the NCT06253871 trial being conducted?
This trial is being conducted at La Jolla, United States, Los Angeles, United States, Aurora, United States, Miami, United States and 11 additional locations.
Who is sponsoring the NCT06253871 clinical trial?
NCT06253871 is sponsored by Iambic Therapeutics, Inc. The principal investigator is Iambic Therapeutics, Inc., Senior Medical Director at Iambic Therapeutics, Inc. The trial plans to enroll 383 participants.