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Anti-tumor antibiotic

IAM1363 Monotherapy for Breast Cancer

Phase 1

Recruiting

Research Sponsored by Iambic Therapeutics, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have relapsed/refractory HER2-altered malignancy

Age ≥ 18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, estimated as 46 months

Awards & highlights

Study Summary

This trial is testing a new drug called IAM1363 on patients with advanced cancers that have specific genetic mutations. They want to see how safe and effective IAM1363 is when given alone or in combination

Who is the study for?

This trial is for adults with advanced cancers that have HER2 alterations. Participants must be able to receive treatment and provide a tumor sample. Specific details on who can or cannot participate are not provided.Check my eligibility

What is being tested?

The study is testing IAM1363, both alone and combined with Trastuzumab, to see how safe it is and if it works against advanced HER2-altered cancers. It's an early-stage trial where doses will be adjusted to find the right balance between safety and effectiveness.See study design

What are the potential side effects?

Potential side effects of IAM1363 and Trastuzumab in treating cancer aren't detailed here, but typically may include reactions at the infusion site, fatigue, nausea, fever, chills or allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has returned or didn't respond to treatment and involves a change in the HER2 gene.

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I am 18 years old or older.

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My cancer has worsened after the last treatment or I couldn't tolerate it.

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I am fully active or can carry out light work.

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My heart pumps blood well (LVEF ≥ 50%).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, estimated as 46 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, estimated as 46 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, estimated as 46 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Confirmed Intra-cranial (IC) ORR (Part 3 Only)

Confirmed Objective Response Rate (ORR)

Incidence of adverse events (AEs) (Parts 1 and 2)

+1 more

Secondary outcome measures

Area under the Time-Concentration Curve (AUC) from dosing (time 0) to the time of the last measured concentration (AUC0-last) of IAM1363

Best Overall Response (BoR) based on RECIST v1.1

Clinical Benefit Rate (CBR) based on RECIST v1.1

+8 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: IAM1363 MonotherapyExperimental Treatment1 Intervention

Treatment with single-agent IAM1363 capsules, administered orally once daily in 21-day cycles from planned dose levels of 120mg to 480mg.

Group II: IAM1363 + trastuzumabExperimental Treatment2 Interventions

Treatment with single-agent IAM1363 capsules, administered once daily in 21-day cycles from planned dose levels of 120mg to 480mg, in combination with trastuzumab, administered per prescribing information as an IV infusion weekly or every 3 weeks, or subcutaneously every 3 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Trastuzumab

2014

Completed Phase 4

~5190

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Iambic Therapeutics, IncLead Sponsor

Chief Medical OfficerStudy DirectorIambic

123 Previous Clinical Trials

21,407 Total Patients Enrolled

2 Trials studying Breast Cancer

155 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment for this medical study currently accepting new participants?

"As per information from clinicaltrials.gov, recruitment for this trial is currently closed. Initially listed on 2/1/2024 and last modified on 2/2/2024, the study has concluded patient enrollment. However, there are alternative trials actively seeking participants at present."

Answered by AI

Has IAM1363 Monotherapy received approval from the FDA for use as a standalone treatment?

"Given that this is a Phase 1 trial with restricted data supporting its safety and effectiveness, IAM1363 Monotherapy was rated as a level 1 for safety by our team at Power."

Answered by AI

What is the primary objective of conducting this clinical trial?

"The primary aim of this clinical investigation, spanning an estimated time frame of 46 months until completion, is to determine the Confirmed Intra-cranial (IC) ORR specifically in Part 3. Additional endpoints include Time to Maximum Concentration of IAM1363 post a single dose and after 15 doses, Disease Control Rate (DCR) according to RECIST v1.1 across all study segments - Parts 1, 2, and 3 - as well as Progression-free Survival (PFS) following RECIST v1.1 criteria for all participant groups within Parts 1, 2, and"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "A Phase 1/1b Study of IAM1363 in HER2 Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06253871.