Brief Title: IAM1363 in HER2 Cancers

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Incidence and severity of dose limiting toxicities (DLTs) (Part 1 only)

Primary Outcome 1 - Timeframe: 21 days

Primary Outcome 2 - Measure: Incidence and severity of adverse events (AEs)

Primary Outcome 2 - Timeframe: Through 30 days after the last dose of study drug

Primary Outcome 3 - Measure: Pharmacokinetic (PK) parameters

Primary Outcome 3 - Timeframe: Up to 42 days

Primary Outcome 4 - Measure: Confirmed objective response rate (cORR)

Primary Outcome 4 - Timeframe: Through study completion

Primary Outcome 5 - Measure: Confirmed central nervous system ORR (CNS-cORR)

Primary Outcome 5 - Timeframe: estimated as 46 months

Primary Outcome 6 - Measure: Frequency of IAM1363 dose modifications

Primary Outcome 6 - Timeframe: Through study completion

Primary Outcome 7 - Measure: including treatment discontinuations

Primary Outcome 7 - Timeframe: estimated as 46 months

Primary Outcome 8 - Measure: Incidence and severity of clinical laboratory abnormalities

Primary Outcome 8 - Timeframe: Through 30 days after the last dose of study drug

Primary Outcome 9 - Measure: Incidence of ECG abnormalities

Primary Outcome 9 - Timeframe: Through 30 days post last dose of study drug

CONDITION

• 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

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Iambic Therapeutics, Inc., Senior Medical Director

Role: Study Director

Affiliation: Iambic Therapeutics, Inc

Overall Contact

Name: Iambic Therapeutics, Inc., Senior Medical Director

Phone: 619-330-5499

Email: [email protected]

LOCATION