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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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.

Eligibility

Primary outcome measure(s)

• Incidence and severity of dose limiting toxicities (DLTs) (Part 1 only) — 21 days
  Incidence and severity of DLTs during the first cycle of treatment in participants in Part 1
• Incidence and severity of adverse events (AEs) — Through 30 days after the last dose of study drug
  Incidence of treatment emergent AEs (TEAEs) and serious adverse events (SAEs)
• Pharmacokinetic (PK) parameters — Up to 42 days
  PK parameters. Includes but is not limited to assessment of maximum concentration (Cmax).
• Confirmed objective response rate (cORR) — Through study completion, estimated as 46 months
  Percentage of participants who achieve a confirmed objective response (complete response \[CR\] + partial response \[PR\]) per the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
• Confirmed central nervous system ORR (CNS-cORR) — Through study completion, estimated as 46 months
  Percentage of participants who achieve a confirmed CNS-cORR (CNS-CR + CNS-PR) per the Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) Criteria
• Frequency of IAM1363 dose modifications, including treatment discontinuations — Through 30 days after the last dose of study drug
• Incidence and severity of clinical laboratory abnormalities — Through 30 days post last dose of study drug
• Incidence of ECG abnormalities — Through 30 days after the last dose of study drug
  As measured using standard ECG parameters, including pulse rate, QT intervals, and QRS duration.

Trial sites (53)

+ 13 more sites — see the full list on the official registry below.