Health Trials

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

ConditionsHER2 Mutation-Related TumorsHER2HER2-positive Breast CancerHER2 + Breast CancerBrain Metastases From Solid TumorsBrain Metastases From HER2 and Breast CancerCNS MetastasesHER2-Positive Solid TumorsNSCLC (Non-small Cell Lung Cancer)HER2-positive Bladder CancerHER2-positive Colorectal CancerHER2 + Gastric CancerHER2-positive Gastroesophageal Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorIambic Therapeutics, Inc

About this trial

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 criteria

Qualifiers

Age ≥ 18 years

Have relapsed/refractory HER2-altered malignancy; for selected cohorts, prospective confirmation of HER2 alteration by central testing is required

Have progression of disease after the last systemic therapy, or be intolerant of last systemic therapy

Have radiographically measurable disease by RECIST v1.1 and/or RANO-BM

Disqualifiers

Clinically significant cardiac disease

Infection with human immunodeficiency virus (HIV)-1 or HIV-2. Exception: Participants with well-controlled HIV (e.g., CD4 >350/mm3 and undetectable viral load) are eligible

Current active liver disease including hepatitis A, hepatitis B , or hepatitis C

Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant small bowel resection that would preclude adequate absorption

Trial design

Treatments tested in this trial

  • IAM1363

Treatment groups

383 Participants
are divided into 1 treatment group

Locations

53
France
Centre Georges François Leclerc21079, Dijon France
Institut de Cancerologie de l'Ouest44805, Saint-Herblain France
Institut Universitaire du Cancer de Toulouse (IUCT) Oncopole Institut Claudius Regaud "31059, Toulouse France
Ireland
The START center DublinD07 R2WY, DublinDublin, Ireland

Sponsors and collaborators

Iambic Therapeutics, Inc

Lead sponsor

Source ClinicalTrials.gov