Spots Global Cancer Trial Database for A Phase 1/1b Study of IAM1363 in HER2 Cancers

Study Description

Brief Summary: This is a Phase 1/1b open-label, multi-center dose escalation and dose optimization study, designed to evaluate safety and preliminary efficacy of IAM1363 as monotherapy and in combination with trastuzumab in patients with advanced cancers that harbor HER2 alterations.

Detailed Description: This is a Phase 1/1b open-label, multi-center study, designed to evaluate IAM1363 as monotherapy and in combination in patients 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) which consists of the following 2 subparts: * Part 2a (Monotherapy Dose Optimization) * Part 2b (Combination with Trastuzumab Dose Selection/Optimization) * Part 3 (Simon 2-Stage Evaluation) Part 1 will enroll patients with confirmed, relapsed/refractory malignancy with documented diagnosis of HER2 alterations including patients with brain metastases. Once a provisional MTD/RP2D is determined, Part 2 will enroll additional cohorts to optimize dose selection and to further evaluate the safety and preliminary efficacy of IAM1363 as monotherapy and in combination with trastuzumab. 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 as monotherapy or in combination with trastuzumab at the selected dose(s).

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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