100 Participants NeededMy employer runs this trial

SOT109 for Colorectal Cancer

Recruiting at 2 trial locations
RK
Overseen ByRichard Kapsa
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new cancer treatment called SOT109, which targets specific markers on cancer cells in colorectal cancer, potentially sparing healthy cells. The trial consists of two parts: the first part identifies safe dose levels, while the second part determines the best dose for effectiveness and safety. It seeks individuals with advanced colorectal cancer that cannot be surgically removed or has spread, and who have already tried standard treatments without success. Participants should have colorectal cancer that has resisted standard therapies and have no other standard treatment options available. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot receive any other cancer treatments while participating. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that SOT109 is likely to be safe for humans?

Research has shown that SOT109 was safe in early lab tests, indicating it was well-tolerated before human testing. The treatment targets CDH17, a marker present in most colorectal cancer cases, while aiming to avoid damage to healthy cells. SOT109 is currently undergoing Phase 1 and Phase 2 clinical trials, which assess its safety in humans and identify any side effects. Although detailed information from human trials is not yet available, early lab results are promising.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about SOT109 for colorectal cancer because it offers a potentially novel approach compared to existing treatments like chemotherapy and targeted therapies. Unlike other treatments that primarily target cancer cells directly, SOT109 may work by modulating the immune system to better recognize and attack cancer cells, which is a fresh angle in treating advanced colorectal cancer. Additionally, SOT109 is administered via IV once every 21 days, potentially offering a more convenient dosing schedule and less frequent hospital visits compared to some existing therapies.

What evidence suggests that SOT109 might be an effective treatment for colorectal cancer?

Research has shown that SOT109 holds promise for treating colorectal cancer. This treatment targets cancer cells with a marker called CDH17, present in over 90% of colorectal cancer cases. In early tests, SOT109 demonstrated strong effects against tumors and appeared safe, effectively fighting cancer cells while remaining safe for patients. The treatment aims to limit harm to healthy cells, potentially resulting in fewer side effects. These findings suggest that SOT109 could be a viable option for patients with advanced colorectal cancer. Participants in this trial will receive varying doses of SOT109 to determine the optimal dosing strategy.15678

Who Is on the Research Team?

JT

Josep Tabernero, M.D., Ph.D.

Principal Investigator

Vall d'Hebron University Hospital (HUVH)

Are You a Good Fit for This Trial?

This trial is for adults with advanced colorectal or biliary tract cancer that cannot be removed by surgery or has spread to other parts of the body. Participants must have tumors with a marker called CDH17 and meet general health requirements.

Inclusion Criteria

I have cancer that can be measured or detected by scans or exams.
Estimated life expectancy ≥3 months as assessed by investigator
I am fully active or can do light work despite my illness.
See 20 more

Exclusion Criteria

History or family history of congenital long QT syndrome
I have had interstitial pneumonitis or pulmonary fibrosis.
I have not had a live vaccine in the past 30 days.
See 21 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Part A: Dose Escalation

Multinational, multicenter, open-label trial to determine the MTD and RP2Ds, evaluating safety, PK, and preliminary efficacy of escalating doses of SOT109

Approximately 12 months
Every 21 days

Part B: Dose Optimization

Randomized, multinational, multicenter, open-label trial evaluating two recommended doses for optimization to identify the optimal biological dose

Approximately 9 months
Every 21 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • SOT109

Trial Overview

The study is testing SOT109, a new medicine designed to target and kill cancer cells with the CDH17 marker while sparing healthy cells. The trial will find out how safe it is, what dose works best, and how patients' bodies handle the drug.

How Is the Trial Designed?

7

Treatment groups

Experimental Treatment

Group I: SOT109 (Part B) recommended dose for optimization 2Experimental Treatment1 Intervention
Group II: SOT109 (Part B) recommended dose for optimization 1Experimental Treatment1 Intervention
Group III: SOT109 (Part A) dose level 5Experimental Treatment1 Intervention
Group IV: SOT109 (Part A) dose level 4Experimental Treatment1 Intervention
Group V: SOT109 (Part A) dose level 3Experimental Treatment1 Intervention
Group VI: SOT109 (Part A) dose level 2Experimental Treatment1 Intervention
Group VII: SOT109 (Part A) dose level 1Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

SOTIO Biotech a.s.

Lead Sponsor

Trials
3
Recruited
270+

Citations

SOTIO Unveils Promising Preclinical Data on SOT109, a ...

SOT109's exatecan payload is expected to demonstrate superior activity, reduced susceptibility to resistance, and an enhanced bystander … ...

Treatment of patients with metastatic colorectal cancer and ...

We performed a systematic review of the treatment outcomes of patients with metastatic colorectal cancer and poor performance status.

FDA Grants Fast Track Designation to SOT109 in ...

CDH17 is expressed in more than 90% of colorectal cancer cases and across other gastrointestinal accelerated approval and priority review,

Abstract 5469: Preclinical safety and efficacy of SOT109, an ...

SOT109 targets the overexpressed tumor antigen CDH17 and exhibits potent anti-tumor efficacy coupled with a clean safety profile in preclinical models of ...

FDA Grants Fast Track Designation to SOTIO's SOT109, a ...

MSS Metastatic Colorectal Cancer Treatment! Exciting results from a phase II trial show sintilimab + bevacizumab, oxaliplatin, and capecitabine as a ...

FDA Grants Fast Track Designation to SOTIO's SOT109, a ...

SOT109 targets CDH17, a highly prevalent antigen expressed in more than 90% of CRC cases and broadly across gastrointestinal malignancies, ...

SOTIO Unveils Promising Preclinical Data on SOT109, a ...

SOT109 is a fully human and highly specific ADC with exceptional binding and internalization properties against CDH17.

Colorectal Cancer | Clinical

FDA fast-tracks alnodesertib and irinotecan for ATM-negative metastatic colorectal cancer, showing promising efficacy and safety in early trials. STELLAR ...