Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
243 participants
INTERVENTIONAL
2024-03-25
2028-03-31
Brief Summary
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Detailed Description
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This study consists of the following 3 parts, which are described in further detail below:
* Part 1 (Monotherapy Dose Escalation)
* Part 2 (Dose Optimization)
* Part 3 (Simon 2-Stage Evaluation)
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).
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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IAM1363 Monotherapy
Treatment with IAM1363 capsules, dosed orally either once or twice daily in 21-day cycles.
IAM1363
Oral, immediate release capsules of IAM1363
Interventions
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IAM1363
Oral, immediate release capsules of IAM1363
Eligibility Criteria
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Inclusion Criteria
* Have relapsed/refractory HER2-altered malignancy
* 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
* Eastern Cooperative Oncology Group (ECOG) performance score 0-1
* Have adequate baseline hematologic, liver and renal function
* Have left ventricular ejection fraction (LVEF) ≥ 50%
Exclusion Criteria
* Infection with human immunodeficiency virus (HIV)-1 or HIV-2. Exception: Patients 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
* Uncontrolled diabetes
* History of solid organ transplantation
* History of Grade ≥2 CNS hemorrhage, or any CNS hemorrhage within 28 days before C1D1
* Patients requiring immediate local therapy for brain metastases
18 Years
ALL
No
Sponsors
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Iambic Therapeutics, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Iambic Therapeutics, Inc., Senior Medical Director
Role: STUDY_DIRECTOR
Iambic Therapeutics, Inc
Locations
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USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
Comprehensive Hematology Oncology
St. Petersburg, Florida, United States
University of Michigan
Ann Arbor, Michigan, United States
START - Midwest Cancer Research Center
Grand Rapids, Michigan, United States
Cleveland Clinic
Cleveland, Ohio, United States
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
NEXT Oncology - Austin
Austin, Texas, United States
NEXT Oncology - Dallas
Dallas, Texas, United States
Mary Crowley Cancer Research
Dallas, Texas, United States
START Mountain Region
West Valley City, Utah, United States
NEXT Oncology - Virginia Cancer Specialists
Fairfax, Virginia, United States
Countries
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Central Contacts
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Iambic Therapeutics, Inc., Senior Medical Director
Role: CONTACT
Phone: 619-330-5499
Email: [email protected]
Other Identifiers
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IAM1363-01
Identifier Type: -
Identifier Source: org_study_id