RecruitingPHASE1INTERVENTIONAL

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

This clinical trial is looking at a new medicine called IAM1363 for people with advanced cancers that have a specific change known as HER2. This includes different types of cancer like breast, lung, and stomach cancer, even if they've spread to the brain. The study has several stages, starting by finding the safest and most effective dose of IAM1363 on its own, then seeing how well it works. Later stages will test the medicine in combination with other anti-cancer treatments. The main goal is to understand how safe IAM1363 is and if it can help shrink or slow down these cancers.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Iambic Therapeutics, Inc

Enrolment target

383

Start

25 Mar 2024

Estimated completion

01 Dec 2028

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

What is this study about?

This research study is about a new medicine called IAM1363. It's being tested for people who have advanced cancers where previous treatments haven't worked or are no longer suitable. The key thing about these cancers is that they all have a specific change called a HER2 alteration. This change can be found in various cancers, such as certain types of breast cancer, lung cancer, bladder cancer, bowel cancer, and stomach cancer, including when these cancers have spread to the brain.

The study is split into different parts. Initially, it's about figuring out the best and safest dose of IAM1363 when given on its own. Researchers will carefully increase the dose for small groups of people to find this 'sweet spot'. Once they know the ideal dose, they'll expand the study to see how well it works in more people with specific HER2-altered cancers.

Later on, the study will also look at whether IAM1363 works even better when combined with other cancer treatments. The overall aim of this trial is to learn more about IAM1363 – how safe it is, what side effects it might cause, and if it can help people whose cancers have these HER2 changes.

Key takeaways

This study tests a new medicine, IAM1363, for advanced HER2-altered cancers.
It aims to find the safest and most effective dose.
It includes various cancers like breast, lung, and stomach cancers, even if they have spread to the brain.
Participation involves taking an oral medicine and regular hospital visits for monitoring.
It's an early-stage trial, so potential benefits and risks are still being understood.

Who may be eligible?

To join this study, you would need to be at least 18 years old and have an advanced cancer with a HER2 alteration that has either grown worse despite previous treatments or you couldn't tolerate those treatments. Doctors will need to be able to measure your cancer on scans.

You would also need to be generally well enough to take part, meaning you can look after yourself for the most part, and your blood tests, heart, liver, and kidney functions are working adequately. You should also be able to swallow medicines given by mouth.

There are some reasons why you might not be able to join. These include having certain significant heart problems, specific active liver conditions like Hepatitis, or if you have uncontrolled diabetes. You also wouldn't be able to join if you have a serious infection, a history of certain lung conditions, or if brain metastases (cancer spread to the brain) need immediate treatment.

Quick self-check

Are you at least 18 years old?
Do you have an advanced cancer with a HER2 alteration that has progressed on previous treatments?
Are you generally well enough to look after yourself?
Can you swallow oral medication?
Do you have good heart, liver, and kidney function?
Do you NOT have serious heart problems or active hepatitis?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

Taking part in this study would involve regular visits to the hospital for check-ups, blood tests, and scans to monitor your health and the cancer. You would take the study medicine, IAM1363, by mouth. The exact schedule for visits and how long you'll be on the treatment will depend on which part of the study you join and how you respond. The study will carefully monitor you for any side effects and to see how the treatment is working. This is a multi-centre study, meaning it's happening in several different hospitals.

Potential risks and benefits

Participating in a clinical trial like this could offer potential benefits, such as access to a new medicine that isn't yet widely available, and close monitoring of your health. However, there are also potential risks involved, mainly from side effects of the new medicine, which are not yet fully known. The research team will explain all known and possible risks to you. Remember, joining a trial is always voluntary, and you have the right to withdraw at any time without giving a reason, and this won't affect your future medical care.

Locations (53)

UCSD Moores Cancer Center
La Jolla, United States· Recruiting
USC Norris Comprehensive Cancer Center
Los Angeles, United States· Recruiting
University of Colorado Cancer Center
Aurora, United States· Recruiting
University of Miami
Miami, United States· Recruiting
Comprehensive Hematology Oncology
St. Petersburg, United States· Recruiting
University of Chicago
Chicago, United States· Recruiting
Massachusetts General Hospital
Boston, United States· Recruiting
Dana Farber Cancer Institute
Boston, United States· Recruiting
University of Michigan
Ann Arbor, United States· Recruiting
Henry Ford Cancer Institute
Detroit, United States· Recruiting
START - Midwest Cancer Research Center
Grand Rapids, United States· Recruiting
Saint Luke's Cancer Institute
Kansas City, United States· Recruiting

+41 more sites — see the official record for the full list.

Common questions

What does 'HER2 alteration' mean?

HER2 is a type of protein that can be found on the surface of cancer cells. An 'alteration' means there's a change in this protein or the gene that makes it, which can cause cancer cells to grow faster. The study medicine targets these specific changes.

What is a 'Phase 1/1b' study?

This is an early-stage study designed primarily to find a safe dose of a new medicine and to see what side effects it might cause. It also starts to look at whether the medicine shows signs of working.

Will IAM1363 cure my cancer?

This is an early study, and it's too soon to say if IAM1363 can cure cancer. The main goal is to see if it's safe and if it can help slow down or shrink HER2-altered cancers.

What are 'brain metastases'?

Brain metastases mean that cancer cells from your original tumour have spread to your brain. This study accepts some people with brain metastases.

Will I get a placebo (dummy drug) in this study?

No, this study is 'open-label', which means everyone who participates will receive the study medicine, IAM1363. There is no placebo group.

How to find out more

Iambic Therapeutics, Inc., Senior Medical Director

ClinicalTrials@Iambic.ai 619-330-5499 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.