A Phase 1/1b Study of IAM1363 in HER2 Cancers

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Key

Inclusion Criteria:

- Age ≥ 18 years.

- Have relapsed/refractory HER2-altered malignancy.

- 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% Key
Exclusion Criteria:
- Clinically significant cardiac disease.

- Infection with human immunodeficiency virus (HIV)-1 or HIV-2.

Exception: Patients 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.

- Patients requiring immediate local therapy for brain metastases

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06253871
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Iambic Therapeutics, Inc
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Iambic Therapeutics, Inc., Senior Medical Director
Principal Investigator Affiliation	Iambic Therapeutics, Inc
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	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

Additional Details

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 3 parts, which are described in further detail below:

- Part 1 (Monotherapy Dose Escalation) - Part 2 (Dose Optimization) - Part 3 (Simon 2-Stage Evaluation) 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).

Arms & Interventions

Arms

Experimental: IAM1363 Monotherapy

Treatment with IAM1363 capsules, dosed orally either once or twice daily in 21-day cycles.

Interventions

Drug: - IAM1363

Oral, immediate release capsules of IAM1363

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

USC Norris Comprehensive Cancer Center, Los Angeles, California

Status

Recruiting

Address

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90089

Site Contact

[email protected]

619-330-5499

Comprehensive Hematology Oncology, Saint Petersburg, Florida

Status

Recruiting