NCT06253871

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

A Phase 1/1b Study of IAM1363 in Participants With Advanced Cancers Harboring HER2 Alterations

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 383 (estimated)
• Sponsor: Iambic Therapeutics, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

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

Interventions

Type	Name	Description
DRUG	IAM1363	IAM1363 monotherapy OR IAM1363 in combination with capecitabine + trastuzumab OR IAM1363 in combination with capecitabine + zanidatamab OR IAM1363 in combination with T-Dxd OR IAM1363 in combination with pembrolizumab +/- carboplatin and pemetrexed

Timeline

• Start date: 2024-03-25
• Primary completion: 2027-12-01
• Completion: 2028-12-01
• First posted: 2024-02-12
• Last updated: 2026-04-13

Locations

48 sites across 8 countries: United States, France, Ireland, Italy, Netherlands, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study