A Phase 1/1b Study of IAM1363 in HER2 Cancers
Purpose
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.
Conditions
- HER2 Mutation-Related Tumors
- HER2
- HER2-positive Breast Cancer
- HER2 + Breast Cancer
- Brain Metastases From Solid Tumors
- Brain Metastases From HER2 and Breast Cancer
- CNS Metastases
- HER2-Positive Solid Tumors
- NSCLC (Non-small Cell Lung Cancer)
- HER2-positive Bladder Cancer
- HER2-positive Colorectal Cancer
- HER2 + Gastric Cancer
- HER2-positive Gastroesophageal Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
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
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Sequential Assignment
- Intervention Model Description
- Dose-escalation and dose optimization
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental IAM1363 Monotherapy or Combination Therapy |
Treatment with IAM1363 capsules, dosed orally alone or in combination with other anti-cancer agents, in 14- or 21-day cycles. |
|
Recruiting Locations
Nashville, Tennessee 37232
More Details
- Status
- Recruiting
- Sponsor
- Iambic Therapeutics, Inc
Study Contact
Iambic Therapeutics, Inc., Senior Medical Director619-330-5499
ClinicalTrials@Iambic.ai
Detailed Description
This is a Phase 1/1b open-label, multi-center study, designed to evaluate IAM1363 in participants with advanced cancers that harbor HER2 alterations. This study consists of the following 4 parts: - Part 1 (Monotherapy Dose Escalation) - Part 2 (Dose Optimization) - Part 3 (Dose Expansion) - Part 4 (Combination Cohorts) Part 1 will enroll participants with a confirmed, relapsed/refractory malignancy with documented diagnosis of HER2 alterations including participants with brain metastases. Once a provisional maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) has been determined, Part 2 will enroll additional cohorts to optimize dose selection and to further evaluate the safety and preliminary efficacy of IAM1363. Following completion of Dose Optimization, Part 3 will be opened to enroll tumor-specific cohorts utilizing a Simon 2-Stage Minimax Design to evaluate IAM1363 at the selected dose(s). Part 4 will enroll 4 cohorts of participants who will receive IAM1363 in combination with other anti-cancer agents.