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IKS014 in Advanced Solid Tumors That Express HER2
This study will evaluate the recommended dose for further clinical development, safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of IKS014, a HER2 targeting antibody-drug conjugate, in patients with advanced solid tumors.
Study details:
The study will consist of 2 parts: dose-escalation (Part 1) and dose-expansion (Part 2). The dose-escalation part (Part 1) of the study is to evaluate the safety and tolerability of increasing dose levels of IKS014 to establish a recommended phase 2 dose (RP2D); and the dose-expansion part (Part 2) of the study is to further evaluate the safety, pharmacokinetics/pharmacodynamics, and efficacy of IKS014 at the RP2D.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-09-14
Primary completion: 2025-09-01
Study completion finish: 2027-09-01
Study type
TREATMENT
Phase
PHASE1
Trial ID
NCT05872295
Intervention or treatment
DRUG: IKS014
Conditions
- • Breast Cancer
- • Gastric Cancer
- • Gastroesophageal-junction Cancer
Find a site
Closest Location:
Westmead Hospital
Research sites nearby
Select from list below to view details:
Westmead Hospital
Westmead, New South Wales, Australia
Alfred Health
Melbourne, Victoria, Australia
Linear Clinical Research
Nedlands, Western Australia, Australia
Concord Repatriation General Hospital Medical Oncology Clinical Trials Unit
Concord, New South Wales, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Dose Escalation Cohort (Part 1)
| DRUG: IKS014
|
EXPERIMENTAL: Dose Expansion: HER2+ Breast Cancer Participants
| DRUG: IKS014
|
EXPERIMENTAL: Dose Expansion: HER2 Low Breast Cancer Participants
| DRUG: IKS014
|
EXPERIMENTAL: Dose Expansion: HER2+ Gastric Cancer or Gastro-esophageal Junction Participants
| DRUG: IKS014
|
EXPERIMENTAL: Dose Expansion: HER2 Low Gastric Cancer or Gastro-esophageal Junction Participants
| DRUG: IKS014
|
EXPERIMENTAL: Dose Expansion: HER2 Solid Tumor Cancer Participants
| DRUG: IKS014
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Recommended Phase 2 Dose (Part 1) | Based on tolerability, preliminary anti-tumor activity, and pharmacokinetics | Up to 24 months |
Objective Response Rate (Part 2) | Anti-tumor activity will be assessed by RECIST 1.1 | Up to 24 months |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Objective Response Rate (Part 1) | Anti-tumor activity will be assessed by RECIST 1.1 | Up to 24 months |
Plasma Concentrations of IKS014 (Part 1 and 2) | Pharmacokinetic parameters will be determined from observed concentrations of IKS014 | Up to 48 months |
Evaluation of the immunogenicity of IKS014 (Part 1 and 2) | Occurrence of ADA measured in serum at selected timepoints during the study | Up to 48 months |
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