This study will evaluate the safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of the IKS04 Regimen and identify a recommended phase 2 dose (RP2D) or recommended dose for further evaluation in expansion (RDE). The regimen includes Isumab04 (unconjugated antibody) followed by the IKS04 antibody-drug conjugate, both directed against the CA242 (CanAg) tumor-associated antigen and administered intravenously (IV) in patients with advanced solid cancers.
The study will consist of 2 parts: dose-escalation (Part I) and dose-expansion (Part II). The dose-escalation part (Part I) will evaluate the safety and tolerability of increasing dose levels of the IKS04 Regimen and to establish a RP2D and/or a RDE; and the dose-expansion portion (Part II) of the study will further characterize the safety, pharmacokinetics/pharmacodynamics, and efficacy of the IKS04 Regimen at the RP2D or RDE. Participants may continue on study until disease progression, unacceptable toxicity, or other withdrawal criteria is met.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
IKS04 Regimen \[Isumab04 (the antibody component of IKS04) followed by IKS04 ADC\]
UCLA Medical Center
Los Angeles, California, United States
Mass General Hospital
Boston, Massachusetts, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
Recommended Phase 2 Dose (Part I)
Based on tolerability, preliminary anti-tumor activity, and pharmacokinetics
Time frame: Up to 24 months
Objective Response Rate (Part II)
Anti-tumor activity will be assessed by RECIST 1.1
Time frame: Up to 24 months
Objective Response Rate
Anti-tumor activity will be assessed by RECIST 1.1
Time frame: Up to 24 months
Maximum Concentration (Cmax) (Part I and II)
Cmax of total ADC, total antibody and unconjugated payload will be measured.
Time frame: Up to 48 months
Area under the plasma concentration versus time curve (AUC) (Part I and II)
AUC of total ADC, total antibody and unconjugated payload will be measured.
Time frame: 48 months
Half-life (T1/2) (Part I and II)
Half-life (T1/2) of total ADC, total antibody and unconjugated payload will be measured.
Time frame: 48 months
Evaluation of Immunogenicity of IKS04 Regimen (Part I and II)
Occurrence of ADA measured in serum at selected timepoints during the study
Time frame: Up to 48 months
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