A Phase 1/1b Study of IAM1363 in Participants with Advanced Cancers Harboring HER2 Alterations
Research type
Research Study
Full title
A Phase 1/1b Study of IAM1363 in Participants with Advanced Cancers Harboring HER2 Alterations
IRAS ID
1012248
Contact name
Vincent Caralli
Contact email
Sponsor organisation
Iambic Therapeutics, Inc.
Clinicaltrials.gov Identifier
Research summary
This is the first study in which the study drug (IAM1363) is being given to humans to block HER2. The study is being done to test the safety and the potential usefulness of IAM1363 in treating patients with certain HER2 cancers. A total of about 243 patients will participate in this study. This study will be conducted in 3 parts: Part 1 is called Dose Escalation, and about 126 participants will be enrolled in this part of the study. Part 2 is called Dose Optimisation, and this part of the study will enrol about 40 participants. Part 3 will test the selected dose of study drug in patients with specific types of cancer to see if it is effective; about 77 participants will be enrolled. Part 2 of the study is designed to learn more about the safety of these doses and to see if they can treat this type of cancer. Participants will be randomly selected (like flipping a coin) to receive one of the 2 doses. A Safety Review Committee, made up of the study doctors and representatives of the Sponsor decided which doses should be tested in Part 2 of the study. The population in Part 2 will include participants with advanced HER TKD mutant cancers with or without brain metastases and HER2-positive cancers with brain metastases not in need of urgent local treatment. Up to approximately 243 evaluable participants: Part 1 (Monotherapy Dose Escalation): up to approximately 126. The dose levels explored in Part 2 will be evaluated qualitatively and no formal sample size was calculated. Randomising at least 20 participants in each arm for Part 2 will provide sufficient information on safety and preliminary anti-tumour activity to determine the recommended dose for Part 3. Part 3 will include up to 77 evaluable participants using independent Simon 2-Stage designs for each of 3 cohorts to assess the anti-tumour activity of IAM1363 at the recommended dose defined in Part 2. The study will last 2 years. The study is sponsored by Iambic Therapeutics, Inc.
REC name
London - Central Research Ethics Committee
REC reference
25/LO/0549
Date of REC Opinion
8 Oct 2025
REC opinion
Further Information Favourable Opinion