Colorectal CancerPhase 1NCT07738939
IKS04 Regimen in Advanced Solid Tumors That Express CA242
A Phase 1 study testing IKS04 antibody drug conjugate ADC + Isumab04 monoclonal antibody in people with Colorectal Cancer and Gastro Esophageal Junctional Cancer, run by Iksuda Therapeutics Ltd. at 4 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Gastro Esophageal Junctional Cancer, Gastric Cancer (GC)
- What is being tested?
- IKS04 antibody drug conjugate ADC + Isumab04 monoclonal antibody
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 4 sitesUnited States
- Study dates
- Nov 2026to Dec 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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) (serum glutamate pyruvate transaminase [SGPT]) ≤ 3 x institutional upper limit of normal (ULN) ≤ 5 x ULN if liver metastases present
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- Total bilirubin ≤ 1.5 x ULN, unless participant has Gilbert's Syndrome
- Albumin > 2.5 g/dL
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
- Part I
- Fresh biopsy tissue or formalin-fixed paraffin-embedded (FFPE) tumor tissue block or slides available for retrospective assessment of CA242 positivity in a central laboratory.
- Measurable and non-measurable disease
- Part II
- Fresh biopsy tissue or FFPE tumor tissue block or slides for assessment of CA242 positivity in a central laboratory prior to administration of first dose of study drug.
- Measurable disease only
Who cannot join
- Participants with a significant pulmonary disease or condition, including:
- Significant symptomatic chronic obstructive pulmonary disease (COPD), as assessed by the Investigator.
- History or any current evidence on imaging studies of interstitial lung disease (ILD), pulmonary fibrosis.
- History of pulmonary inflammatory disease, pneumonitis, acute respiratory distress syndrome (ARDS).
- History of pneumonia within 3 months prior to the first trial drug administration.
- Participants who have received previous treatment with any CA242 directed ADC or any ADC containing a PBD payload for their current tumor indication.
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- Participant may not have received more than 5 prior lines of systemic therapy.
- Received treatment with a strong cytochrome P450 (CYP) 3A4 inhibitor within 7 days or 5 half-lives (whichever is longer) prior to the first trial drug administration
- Central nervous system metastatic disease unless treated prior to first dose of trial drug.
- Active second malignancy or history of another malignancy within the last 2 years with specific exceptions as per protocol
- Active, known or suspected autoimmune disease, or a documented history of autoimmune disease or syndrome requiring systemic steroids or other immunosuppressive medications, such as:
- Myocarditis, pneumonitis, glomerulonephritis.
- Autoimmune hepatitis, inflammatory bowel disease (IBD)
- Sjogren's syndrome
- Rheumatoid arthritis (RA), systemic lupus erythematosus (SLE)
- Myositis
- Myasthenia gravis
- Guillain-Barré Syndrome
- Multiple sclerosis
- Granulomatosis with polyangiitis (Wegner's granulomatosis)
- Vasculitis
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites
Mass General Hospital
Boston, Massachusetts, 02114
Leon Pappas, MD
MD Anderson Cancer Center
Houston, Texas, 77030
Kanwal Raghav, MD
UCLA Medical Center
Los Angeles, California, 90404
Randy Hecht, MD
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Jordan Berlin, MD
About this study
Official title: A Phase 1 Dose Escalation Trial to Determine the Safety, Tolerance, Maximum Tolerated Dose, and Preliminary Antineoplastic Activity of the IKS04 Regimen Targeting CA242
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.
Read the detailed 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.
- Conditions
- Colorectal Cancer, Gastro Esophageal Junctional Cancer, Gastric Cancer (GC), GEJ Adenocarcinoma, PDAC - Pancreatic Ductal Adenocarcinoma, Biliary Tract Cancer (BTC)
- Being tested
- IKS04 antibody drug conjugate ADC + Isumab04 monoclonal antibody
- Keywords
- CA242, advanced gastrointestinal tumors, IKS04, Isumab04
- Medical subject headings
- Colorectal Neoplasms, Stomach Neoplasms, Biliary Tract Neoplasms, Gallbladder Neoplasms, Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IKS04 antibody drug conjugate ADC + Isumab04 monoclonal antibodyDrug
IKS04 Regimen [Isumab04 (the antibody component of IKS04) followed by IKS04 ADC]
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation Cohort (Part I) | Experimental | Each patient will receive repeat doses by IV infusions on Day 1 of each 21-day cycle. Receives: Drug: IKS04 antibody drug conjugate ADC + Isumab04 monoclonal antibody |
| Dose Expansion (Part II): CA242+ Colorectal Cancer Participants | Experimental | The IKS04 Regimen will be administered IV at the RP2D or RDE identified in Part I on Day 1 of each 21-day cycle. Receives: Drug: IKS04 antibody drug conjugate ADC + Isumab04 monoclonal antibody |
| Dose Expansion (Part II): CA242+ Gastro-Esophageal Adenocarcinoma Participants | Experimental | The IKS04 Regimen will be administered IV at the RP2D or RDE identified in Part I on Day 1 of each 21-day cycle. Receives: Drug: IKS04 antibody drug conjugate ADC + Isumab04 monoclonal antibody |
| Dose Expansion (Part II): CA242+ Biliary Tract Cancer Participants | Experimental | The IKS04 Regimen will be administered IV at the RP2D or RDE identified in Part I on Day 1 of each 21-day cycle. Receives: Drug: IKS04 antibody drug conjugate ADC + Isumab04 monoclonal antibody |
| Dose Expansion (Part II): CA242+ Advanced Solid Tumor Cancer Participants | Experimental | The IKS04 Regimen will be administered IV at the RP2D or RDE identified in Part I on Day 1 of each 21-day cycle. Receives: Drug: IKS04 antibody drug conjugate ADC + Isumab04 monoclonal antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended Phase 2 Dose (Part I)
Based on tolerability, preliminary anti-tumor activity, and pharmacokinetics
Measured: Up to 24 months
Objective Response Rate (Part II)
Anti-tumor activity will be assessed by RECIST 1.1
Measured: Up to 24 months
Secondary outcomes (5)
Objective Response Rate
Anti-tumor activity will be assessed by RECIST 1.1
Measured: Up to 24 months
Maximum Concentration (Cmax) (Part I and II)
Cmax of total ADC, total antibody and unconjugated payload will be measured.
Measured: 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.
Measured: 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.
Measured: 48 months
Evaluation of Immunogenicity of IKS04 Regimen (Part I and II)
Occurrence of ADA measured in serum at selected timepoints during the study
Measured: Up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study startNov 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iksuda Therapeutics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James O'Leary, MD, Study director, Iksuda Therapeutics Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07738939
- Sponsor's protocol ID
- IKS04-01
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Dose Escalation Trial to Determine the Safety, Tolerance, Maximum Tolerated Dose, and Preliminary Antineoplastic Activity of the IKS04 Regimen Targeting CA242
- ClinicalTrials.gov ID
- NCT07738939
- Acronym / sponsor ID
- IKS04-01
- Conditions
- Colorectal Cancer, Gastro Esophageal Junctional Cancer, Gastric Cancer (GC), GEJ Adenocarcinoma, PDAC - Pancreatic Ductal Adenocarcinoma, Biliary Tract Cancer (BTC)
- Keywords
- CA242, advanced gastrointestinal tumors, IKS04, Isumab04
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Iksuda Therapeutics Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 31 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation Cohort (Part I) | Experimental | Drug: IKS04 antibody drug conjugate ADC + Isumab04 monoclonal antibodyEach patient will receive repeat doses by IV infusions on Day 1 of each 21-day cycle. |
| Dose Expansion (Part II): CA242+ Colorectal Cancer Participants | Experimental | Drug: IKS04 antibody drug conjugate ADC + Isumab04 monoclonal antibodyThe IKS04 Regimen will be administered IV at the RP2D or RDE identified in Part I on Day 1 of each 21-day cycle. |
| Dose Expansion (Part II): CA242+ Gastro-Esophageal Adenocarcinoma Participants | Experimental | Drug: IKS04 antibody drug conjugate ADC + Isumab04 monoclonal antibodyThe IKS04 Regimen will be administered IV at the RP2D or RDE identified in Part I on Day 1 of each 21-day cycle. |
| Dose Expansion (Part II): CA242+ Biliary Tract Cancer Participants | Experimental | Drug: IKS04 antibody drug conjugate ADC + Isumab04 monoclonal antibodyThe IKS04 Regimen will be administered IV at the RP2D or RDE identified in Part I on Day 1 of each 21-day cycle. |
| Dose Expansion (Part II): CA242+ Advanced Solid Tumor Cancer Participants | Experimental | Drug: IKS04 antibody drug conjugate ADC + Isumab04 monoclonal antibodyThe IKS04 Regimen will be administered IV at the RP2D or RDE identified in Part I on Day 1 of each 21-day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (21 listed)
- Participants with a significant pulmonary disease or condition, including:
- Participants who have received previous treatment with any CA242 directed ADC or any ADC containing a PBD payload for their current tumor indication.
- Participant may not have received more than 5 prior lines of systemic therapy.
- Received treatment with a strong cytochrome P450 (CYP) 3A4 inhibitor within 7 days or 5 half-lives (whichever is longer) prior to the first trial drug administration
- Central nervous system metastatic disease unless treated prior to first dose of trial drug.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IKS04 antibody drug conjugate ADC + Isumab04 monoclonal antibodyIKS04 Regimen [Isumab04 (the antibody component of IKS04) followed by IKS04 ADC] | Drug | Dose Escalation Cohort (Part I), Dose Expansion (Part II): CA242+ Advanced Solid Tumor Cancer Participants, Dose Expansion (Part II): CA242+ Biliary Tract Cancer Participants, Dose Expansion (Part II): CA242+ Colorectal Cancer Participants, Dose Expansion (Part II): CA242+ Gastro-Esophageal Adenocarcinoma Participants |
Primary outcome
Recommended Phase 2 Dose (Part I)
Time frame: Up to 24 months
Based on tolerability, preliminary anti-tumor activity, and pharmacokinetics
Objective Response Rate (Part II)
Time frame: Up to 24 months
Anti-tumor activity will be assessed by RECIST 1.1
5 secondary outcomes
Objective Response Rate
Time frame: Up to 24 months
Maximum Concentration (Cmax) (Part I and II)
Time frame: Up to 48 months
Area under the plasma concentration versus time curve (AUC) (Part I and II)
Time frame: 48 months
Half-life (T1/2) (Part I and II)
Time frame: 48 months
Evaluation of Immunogenicity of IKS04 Regimen (Part I and II)
Time frame: Up to 48 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
James O'Leary, MD study director
Iksuda Therapeutics Ltd.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IKS04 antibody drug conjugate ADC + Isumab04 monoclonal antibody in people with Colorectal Cancer and Gastro Esophageal Junctional Cancer, run by Iksuda Therapeutics Ltd. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Browning (+615-975-7776, david.browning@iksuda.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recommended Phase 2 Dose (Part I) (time frame: Up to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.