SOT109 for Colorectal Cancer
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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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
Part B: Dose Optimization
Randomized, multinational, multicenter, open-label trial evaluating two recommended doses for optimization to identify the optimal biological dose
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
Patients with advanced unresectable or metastatic colorectal cancer treated with SOT109 given once every 21 days via the IV route over 30 (±15) minutes.
Patients with advanced unresectable or metastatic colorectal cancer treated with SOT109 given once every 21 days via the IV route over 30 (±15) minutes.
Patients with advanced unresectable or metastatic colorectal cancer treated with SOT109 given once every 21 days via the IV route over 30 (±15) minutes.
Patients with advanced unresectable or metastatic colorectal cancer treated with SOT109 given once every 21 days via the IV route over 30 (±15) minutes.
Patients with advanced unresectable or metastatic colorectal cancer treated with SOT109 given once every 21 days via the IV route over 30 (±15) minutes.
Patients with advanced unresectable or metastatic colorectal cancer treated with SOT109 given once every 21 days via the IV route over 30 (±15) minutes.
Patients with advanced unresectable or metastatic colorectal cancer treated with SOT109 given once every 21 days via the IV route over 30 (±15) minutes.
Find a Clinic Near You
Who Is Running the Clinical Trial?
SOTIO Biotech a.s.
Lead Sponsor
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.
3.
onclive.com
onclive.com/view/fda-grants-fast-track-designation-to-sot109-in-advanced-colorectal-cancerFDA 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,
4.
aacrjournals.org
aacrjournals.org/cancerres/article/85/8_Supplement_1/5469/760259/Abstract-5469-Preclinical-safety-and-efficacy-ofAbstract 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, ...
7.
businesswire.com
businesswire.com/news/home/20250303272507/en/SOTIO-Unveils-Promising-Preclinical-Data-on-SOT109-a-Next-Gen-ADC-Targeting-Cadherin-17-CDH17-for-Colorectal-CancerSOTIO 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 ...
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