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

Conditions

• Colorectal Cancer (Locally Advanced or Metastatic)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed

Jul 9, 2026

Start date

Jun 29, 2026

Status verified

Jul 2026

Primary completion

Nov 29, 2027

Completion

Jul 4, 2028

Study Design

Enrollment

100 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: SOT109 (Part A) dose level 1
  Patients with advanced unresectable or metastatic colorectal cancer treated with SOT109 given once every 21 days via the IV route over 30 (±15) minutes.
• Experimental: SOT109 (Part A) dose level 2
  Patients with advanced unresectable or metastatic colorectal cancer treated with SOT109 given once every 21 days via the IV route over 30 (±15) minutes.
• Experimental: SOT109 (Part A) dose level 3
  Patients with advanced unresectable or metastatic colorectal cancer treated with SOT109 given once every 21 days via the IV route over 30 (±15) minutes.
• Experimental: SOT109 (Part A) dose level 4
  Patients with advanced unresectable or metastatic colorectal cancer treated with SOT109 given once every 21 days via the IV route over 30 (±15) minutes.
• Experimental: SOT109 (Part A) dose level 5
  Patients with advanced unresectable or metastatic colorectal cancer treated with SOT109 given once every 21 days via the IV route over 30 (±15) minutes.
• Experimental: SOT109 (Part B) recommended dose for optimization 1
  Patients with advanced unresectable or metastatic colorectal cancer treated with SOT109 given once every 21 days via the IV route over 30 (±15) minutes.
• Experimental: SOT109 (Part B) recommended dose for optimization 2
  Patients with advanced unresectable or metastatic colorectal cancer treated with SOT109 given once every 21 days via the IV route over 30 (±15) minutes.

Primary Outcome Measure

Part A: Maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of SOT109 [ Time Frame: At the end of Cycle 1 (one cycle is 21 days) ]

Central Contacts

• Richard Kapsa
  (+420) 2241 74448
  [email protected]

Locations (2)

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