IKS014 in Advanced Solid Tumors That Express HER2
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorIksuda Therapeutics Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
HER2 positive solid tumors with expression defined as IHC3+, IHC2+/ISH+, or low HER2 expression defined as IHC2+ (ISH-) or IHC1+ (ISH- /+ or untested).
Participants with HR positive BC must have received prior treatment with a CDK4/6 inhibitor, in countries where this is standard therapy.
Platelets ≥ 75,000 /mcL
Hemoglobin ≥ 9.0 g/dL
Disqualifiers
History of (noninfectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.
Any clinically apparent ≥ Grade 2 pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (i.e., pulmonary emboli within three months of the trial enrollment, severe asthma, severe chronic obstructive pulmonary disease [COPD], restrictive lung disease, pleural effusion, etc.), and any autoimmune, connective tissue or inflammatory disorders with potential pulmonary involvement (e.g., rheumatoid arthritis, Sjogren's, sarcoidosis), or prior pneumonectomy.
Current evidence of ≥ Grade 2 keratitis or other corneal abnormality.
Evidence of a clinically significant (≥ Grade 2) abnormality on slit-lamp examination or other clinically significant ophthalmologic finding, as determined by an ophthalmologist.
Trial design
Design model
Sequential
Treatments tested in this trial
IKS014
DrugIKS014 is a human monoclonal antibody (Ab) targeting HER2 linked to monomethyl auristatin F (MMAF) cytotoxic agent.
Treatment groups
165 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Dose Escalation Cohort (Part 1)Experimental treatment 1 intervention
Group B: Dose Expansion: HER2+ Breast Cancer ParticipantsExperimental treatment 1 intervention
Group C: Dose Expansion: HER2 Low Breast Cancer ParticipantsExperimental treatment 1 intervention
Group D: Dose Expansion: HER2+ Gastric Cancer or Gastro-esophageal Junction ParticipantsExperimental treatment 1 intervention
Group E: Dose Expansion: HER2 Low Gastric Cancer or Gastro-esophageal Junction ParticipantsExperimental treatment 1 intervention
Group F: Dose Expansion: HER2 Solid Tumor Cancer ParticipantsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Recommended Phase 2 Dose (Part 1)
Based on tolerability, preliminary anti-tumor activity, and pharmacokinetics
Time frame
Up to 24 months2
Objective Response Rate (Part 2)
Anti-tumor activity will be assessed by RECIST 1.1
Time frame
Up to 24 monthsSecondary outcomes
1
Objective Response Rate (Part 1)
Anti-tumor activity will be assessed by RECIST 1.1
Time frame
Up to 24 months2
Plasma Concentrations of IKS014 (Part 1 and 2)
Pharmacokinetic parameters will be determined from observed concentrations of IKS014
Time frame
Up to 48 months3
Evaluation of the immunogenicity of IKS014 (Part 1 and 2)
Occurrence of ADA measured in serum at selected timepoints during the study
Time frame
Up to 48 monthsSponsors and contacts
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Source ClinicalTrials.gov