IKS04 Regimen in Advanced Solid Tumors That Express CA242

Part of paid clinical trials in Los Angeles, California.

Sponsor
Iksuda Therapeutics Ltd.
Study ID
NCT07738939
Phase
PHASE1
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Biliary Tract Cancer (BTC)
  • Cholangiocarcinoma
  • Colorectal Cancer
  • GEJ Adenocarcinoma
  • Gall Bladder Cancer
  • Gastric Cancer (GC)
  • Gastro Esophageal Junctional Cancer
  • PDAC - Pancreatic Ductal Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IKS04 antibody drug conjugate ADC + Isumab04 monoclonal antibody — DRUG
    IKS04 Regimen \[Isumab04 (the antibody component of IKS04) followed by IKS04 ADC\]

Study Details

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.

Key Dates

First listed
Jul 31, 2026
Start date
Nov 30, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
120 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation Cohort (Part I)
    Each patient will receive repeat doses by IV infusions on Day 1 of each 21-day cycle.
  • Experimental: Dose Expansion (Part II): CA242+ Colorectal Cancer Participants
    The IKS04 Regimen will be administered IV at the RP2D or RDE identified in Part I on Day 1 of each 21-day cycle.
  • Experimental: Dose Expansion (Part II): CA242+ Gastro-Esophageal Adenocarcinoma Participants
    The IKS04 Regimen will be administered IV at the RP2D or RDE identified in Part I on Day 1 of each 21-day cycle.
  • Experimental: Dose Expansion (Part II): CA242+ Biliary Tract Cancer Participants
    The IKS04 Regimen will be administered IV at the RP2D or RDE identified in Part I on Day 1 of each 21-day cycle.
  • Experimental: Dose Expansion (Part II): CA242+ Advanced Solid Tumor Cancer Participants
    The IKS04 Regimen will be administered IV at the RP2D or RDE identified in Part I on Day 1 of each 21-day cycle.

Primary Outcome Measure

Recommended Phase 2 Dose (Part I) [ Time Frame: Up to 24 months ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
UCLA Medical CenterLos AngelesCalifornia90404
Randy Hecht, MD (PRINCIPAL_INVESTIGATOR)
Mass General HospitalBostonMassachusetts02114
Leon Pappas, MD (PRINCIPAL_INVESTIGATOR)
Vanderbilt University Medical CenterNashvilleTennessee37232
Jordan Berlin, MD (PRINCIPAL_INVESTIGATOR)
MD Anderson Cancer CenterHoustonTexas77030
Kanwal Raghav, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

Nationwide
Colorectal cancer trialsOncology trialsGI oncology trials
By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
UCLA Medical Center· Los Angeles, CAMass General Hospital· Boston, MAVanderbilt University Medical Center· Nashville, TNMD Anderson Cancer Center· Houston, TX

Related Studies