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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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • IAM1363

    Drug

    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

Treatment groups

383 Participants
are divided into 1 treatment group
Group A: IAM1363 Monotherapy or Combination TherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence and severity of dose limiting toxicities (DLTs) (Part 1 only)

Incidence and severity of DLTs during the first cycle of treatment in participants in Part 1

Time frame
21 days
2

Incidence and severity of adverse events (AEs)

Incidence of treatment emergent AEs (TEAEs) and serious adverse events (SAEs)

Time frame
Through 30 days after the last dose of study drug
3

Pharmacokinetic (PK) parameters

PK parameters. Includes but is not limited to assessment of maximum concentration (Cmax).

Time frame
Up to 42 days
4

Confirmed objective response rate (cORR)

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

Time frame
Through study completion, estimated as 46 months

Secondary outcomes

1

Best overall response (BoR) rate

BoR defined as the best response per RECIST v1.1 and RANO-BM across all assessments

Time frame
Through study completion, estimated as 46 months
2

Duration of response (DoR)

DoR defined as the time between the first confirmed objective response per RECIST v1.1 and RANO-BM and date of disease progression per RECIST v1.1 and RANO-BM or death due to any cause

Time frame
Through study completion, estimated as 46 months
3

Disease control rate (DCR)

DCR defined as the percentage of participants who achieve CR or PR, or stable disease (SD) per RECIST v1.1 and RANO-BM

Time frame
Through study completion, estimated as 46 months
4

Clinical benefit rate (CBR)

CBR defined as the percentage of participants who achieve CR, PR, or SD per RECIST v1.1 and RANO-BM consecutively for 3 months

Time frame
Through study completion, estimated as 46 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Iambic Therapeutics, Inc

Lead sponsor

Source ClinicalTrials.gov
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