A Phase 1 Dose Escalation Trial to Determine the Safety, Tolerance, Maximum Tolerated Dose, and Preliminary Antineoplastic Activity of the IKS04 Regimen Targeting CA242
Iksuda Therapeutics Ltd.
Summary
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.
Description
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: * Advanced or metastatic CRC, BTCs, GEA, and PDAC that is histologically or cytologically confirmed * Disease that has progressed despite prior treatment, for which additional effective therapy is not available, not tolerable, is contraindicated, or the participant refuses standard therapy. * Platelets ≥ 100,000 /mcL * Hemoglobin ≥ 9.0 g/dL., no transfusions with RBCs are allowed within 2 weeks prior to first trial drug administration * ANC ≥ 1500/mcL * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (s…