A Study Testing SOT109 for the First Time in Patients, to Assess How Safe SOT109 is, How Well it Works, and How the Body Handles it in Patients With Advanced Colorectal Cancer That Can Not be Removed by Surgery or is Metastatic

NCT07693751 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 3 other identifiers: 109S012026-526235-19-00CADENCIA-01
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 3

Brief Summary

SOT109 is a special cancer medicine designed to find and kill certain cancer cells that carry a marker called CDH17, while causing less harm to healthy cells. The study consists of two parts, Part A and Part B. The goal of Part A is to collect information about SOT109, understand its effects, and see whether it is safe and well tolerated at different dose levels. Part B of the study collects information on which of the two selected safe dose levels chosen in Part A gives the best balance between benefit and risk.

Conditions

Colorectal Cancer (Locally Advanced or Metastatic)

Keywords

Colorectal Cancer

Outcome Measures

Primary Outcomes (4)

• Part A: Maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of SOT109

  MTD will be selected as guided by the time to-event Bayesian optimal interval (TITEBOIN) design. The RP2D will be selected based on integrated evaluation of the totality of clinical and preclinical data, for all dose levels tested.

  At the end of Cycle 1 (one cycle is 21 days)

• Part B: Optimal dose of SOT109 for subsequent clinical trials

  Assessment of the safety and tolerability of two recommended doses under evaluation for dose optimization (RDOs) of SOT109 by evaluation of the occurrence of SOT109 related TEAEs, serious TEAEs, TEAEs leading to premature discontinuation of SOT109, deaths, and clinical laboratory test abnormalities of grade 3 or higher according to NCI CTCAE Version 6.0

  Cycle 1 Day 1 up to 30 days after the last dose (each cycle is 21 days)

• Part B: Objective Response Rate (ORR) of SOT109

  Percentage of participants who achieve a Best Overall Response of Complete Response (CR) or Partial Response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

  From Day 1 of Cycle 1 (one cycle is 21 days) until disease progression, initiation of new anticancer therapy, withdrawal of consent, or study discontinuation, whichever comes first, to be assessed up to approximately 9 months

• Part B: Duration of Response (DoR) of SOT109

  The time from the first documentation of objective response (CR or PR) to the first documented date of progressive disease (PD) according to RECIST v1.1.

  From the date of first documented objective response until disease progression, initiation of new anticancer therapy, withdrawal of consent, or study discontinuation, whichever comes first, assessed up to approximately 9 months.

Secondary Outcomes (11)

• Part A: Safety and Tolerability of SOT109

  From Cycle 1 Day 1 (one cycle is 21 days) assessed for approximately 12 months

• Part A: Characterization of maximum concentration (Cmax)

  From Cycle 1 Day 1 up to approximately 12 months (each cycle is 21 days)

• Part A: Characterization of time to maximum concentration (Tmax)

  From Cycle 1 Day 1 up to approximately 12 months (each cycle is 21 days)

• Part A: Characterization of area under the curve

  From Cycle 1 Day 1 up to approximately 12 months (each cycle is 21 days)

• Part A: Preliminary anticancer activity of SOT109

  From Day 1 of Cycle 1 (one cycle is 21 days) until disease progression, initiation of new anticancer therapy, withdrawal of consent, or study discontinuation, whichever comes first, to be assessed up to approximately 12 months

Study Arms (7)

SOT109 (Part A) dose level 1

EXPERIMENTAL

Patients with advanced unresectable or metastatic colorectal cancer treated with SOT109 given once every 21 days via the IV route over 30 (±15) minutes.

Biological: SOT109

SOT109 (Part A) dose level 2

EXPERIMENTAL

Patients with advanced unresectable or metastatic colorectal cancer treated with SOT109 given once every 21 days via the IV route over 30 (±15) minutes.

Biological: SOT109

SOT109 (Part A) dose level 3

EXPERIMENTAL

Patients with advanced unresectable or metastatic colorectal cancer treated with SOT109 given once every 21 days via the IV route over 30 (±15) minutes.

Biological: SOT109

SOT109 (Part A) dose level 4

EXPERIMENTAL

Patients with advanced unresectable or metastatic colorectal cancer treated with SOT109 given once every 21 days via the IV route over 30 (±15) minutes.

Biological: SOT109

SOT109 (Part A) dose level 5

EXPERIMENTAL

Patients with advanced unresectable or metastatic colorectal cancer treated with SOT109 given once every 21 days via the IV route over 30 (±15) minutes.

Biological: SOT109

SOT109 (Part B) recommended dose for optimization 1

EXPERIMENTAL

Patients with advanced unresectable or metastatic colorectal cancer treated with SOT109 given once every 21 days via the IV route over 30 (±15) minutes.

Biological: SOT109

SOT109 (Part B) recommended dose for optimization 2

EXPERIMENTAL

Patients with advanced unresectable or metastatic colorectal cancer treated with SOT109 given once every 21 days via the IV route over 30 (±15) minutes.

Biological: SOT109

Interventions

SOT109 BIOLOGICAL

SOT109 is a CDH17-directed monoclonal antibody conjugated to a linker-payload, exatecan

SOT109 (Part A) dose level 1; SOT109 (Part A) dose level 2; SOT109 (Part A) dose level 3; SOT109 (Part A) dose level 4; SOT109 (Part A) dose level 5; SOT109 (Part B) recommended dose for optimization 1; SOT109 (Part B) recommended dose for optimization 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years of age on the day of signing the ICF
• Able to understand, sign, and provide written informed consent to participate in the trial
• Estimated life expectancy ≥3 months as assessed by the investigator
• An appropriate candidate for experimental therapy as assessed by the investigator
• Agrees not to participate in other interventional clinical trial while enrolled in the present trial (with the exception of survival follow-up period)
• Absolute neutrophil count ≥1.5×109/L, platelets ≥100×109/L, hemoglobin ≥9 g/dL
• Creatinine clearance ≥60 mL/min calculated by Cockcroft-Gault formula
• Bilirubin ≤1.5× upper limits of normal (ULN), ALT and AST ≤2.5×ULN; in case of liver involvement: AST and ALT ≤5×ULN
• Participants with a documented history of Gilbert syndrome may be eligible if:
• Total bilirubin is ≤2.0 × ULN,
• Direct (conjugated) bilirubin is within normal limits (≤ULN), and
• There is no evidence of active liver disease, clinically significant hepatic impairment, hemolysis, or biliary obstruction, as determined by the investigator
• Prothrombin time/international normalized ratio ≤1.5×ULN
• Albumin ≥3.0 mg/dL
• Serum concentrations of potassium, magnesium, and calcium with abnormalities of maximum grade 1 that should be treated according to standard practice

You may not qualify if:

• Received radiation therapy ≤14 days before day 1 of cycle 1 or not recovered to grade ≤1 from treatment-related side effects
• Any prior systemic therapy for metastatic cancer other than colorectal cancer; exception:
• stable disease under hormonal treatment for prostate cancer, stable disease under hormonal treatment for breast cancer; radiochemotherapy is allowed if such treatment is completed at least 4 weeks prior to day 1 of cycle 1; participants must have recovered to grade ≤1 from all side effects (exception: alopecia)
• Participants must not receive any concurrent antitumor therapy while participating in the trial. In exceptional circumstances where urgent palliative radiotherapy to symptomatic non-target lesions is clinically indicated, the case must be reviewed with the Principal Investigator (PI) and the intervention must receive prior approval from the sponsor
• Vaccination with a live or live-attenuated vaccine within 30 days prior to the first dose of trial interventions; the full series (e.g., both doses of a two dose vaccination series) should be completed prior to dosing if feasible
• Time since last transfusion of red blood cells ≤14 days before day 1 of cycle 1
• Severe preexisting medical conditions as per judgment of the investigator
• History of interstitial pneumonitis or pulmonary fibrosis
• Symptomatic central nervous system malignancy. Participants with asymptomatic or treated central nervous system metastases may be eligible if they are not treated with corticosteroids or anticonvulsants and the disease is stable for at least 60 days
• Peripheral sensory neuropathy grade ≥2
• Active infection requiring systemic therapy that is not clinically controlled before the signature of the ICF
• Known symptomatic HIV positive, symptomatic active HBV, or symptomatic active HCV
• Note:
• Participants with HIV will be eligible if:
• CD4+ T-cell counts ≥350 cells/μL

Sponsors & Collaborators

• SOTIO Biotech a.s.: lead

Study Sites (3)

NEXT Houston

Houston, Texas, 77054, United States

Location

NEXT Virginia

Faifax, Virginia, 22031, United States

Location

Arensia Exploratory Medicine Research Unit, Institute of Oncology

Chisinau, Moldova

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Josep Tabernero, M.D., Ph.D.

  Vall d'Hebron University Hospital (HUVH)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard Kapsa

CONTACT

(+420) 2241 74448; kapsa@sotio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part A: 5 cohorts, dose-escalation, Time-to-Event Bayesian Optimal Interval Design (TITE-BOIN) trial. Part B: Randomized, open-label dose optimization trial

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 9, 2026
• Study Start: June 29, 2026
• Primary Completion (Estimated): November 29, 2027
• Study Completion (Estimated): July 4, 2028
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); MO (1)