Recruiting
Phase 2

DSP107 & Atezolizumab

Sponsor:

Kahr Bio Australia Pty Ltd

Code:

NCT07235293

Conditions

Colorectal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

DSP107 + Atezolizumab

Fruquintinib

Study Details

Brief summary:

This clinical study is testing whether a new combination of medicines (DSP107 and atezolizumab) is more effective and safer than an existing treatment (fruquintinib) for people with advanced colorectal cancer that is microsatellite stable (MSS). Participants will be randomly assigned to receive one of the two treatments, and researchers will monitor how well the cancer responds, how safe the treatments are, and how the body processes them. The study hopes to show that the new combination can improve outcomes for patients with this type of colorectal cancer.

Conditions

Colorectal Cancer

Study ID

NCT07235293

Start date

Jan 16, 2026

Status verified date

Sep, 2025

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Are ≥ 18 years of age with a life expectancy of > 3 months.
2. Participants with histologically confirmed, inoperable, MSS and/or pMMR CRC which has progressed to, or is intolerant to, specified therapies (and has received prior treatment with no more than 3 lines of therapy).
3. Measurable disease per RECIST v1.1.

Exclusion Criteria:

1. Central nervous system (CNS) metastases unless stable 2 months post definitive therapy with steroids.
2. Unresolved AEs of Grade 2 or higher from prior anticancer therapy.
3. Past or current history of autoimmune disease or immune deficiency.
4. History of other malignancy within 3 years of first study treatment cycle.
5. Current or recent treatment with certain therapies including specified anticancer treatments, modulators of CYP3A4 and immunomodulating therapies (prior treatment with CPIs is not exclusory).
6. Known allergy or hypersensitivity to any of the test compounds, materials, or contraindication to test product.
7. Clinically significant abnormal laboratory safety tests.

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: DSP107 in combination with Atezolizumab

DSP107 10 mg/kg IV on Days 1, 8, and 15 of each 28-day cycle. Atezolizumab 1680 mg IV on Day 1 of each 28-day cycle.

active comparator: Fruquintinib

Participants will receive fruquintinib orally in 28-day cycles, for up to 24 cycles (96 weeks), or until disease progression, unacceptable toxicity, or study withdrawal.

Interventions

DSP107 + Atezolizumab

DSP107 infusion begins \~30 (±10) minutes after completion of atezolizumab infusion on Day 1.

Fruquintinib

5 mg orally, once daily (with or without food), on Days 1-21 of each 28-day cycle, followed by 7 days off.

Primary outcome measure

  • To determine Median overall survival (mOS) in participants treated with the combination of DSP107 and atezolizumab versus fruquintinib. [ Time Frame: From Day 1 until date of death from any cause assessed up to 2 years ]

Central Contacts and Locations

Central contacts

Adam Foley Comer

+972 54 749 1753adam@kahrbio.com

Locations

University of Colorado Hospital- Anschutz Cancer Center Pavillion (ACP)

Recruiting

Aurora, Colorado, United States, 80045

Principal Investigator:

Hannah Robinson

University of Colorado Cancer Center - Highlands Ranch Hospital

Recruiting

Highlands Ranch, Colorado, United States, 80129

Principal Investigator:

Hannah Robinson

Mayo Clinic

Recruiting

Florida City, Florida, United States, 32224

Principal Investigator:

Conor O'Donnell, Dr

Duke University Medical Center - Duke Cancer Center

Recruiting

Durham, North Carolina, United States, 27710

Principal Investigator:

Nicholas DeVito

UPMC Hillman Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Principal Investigator:

Anwaar Saeed, MD

The University of Texas MD Anderson Cancer Center

Recruiting

Texas City, Texas, United States, 77030

Principal Investigator:

Maria Pia Morelli, MD

More Information

Sponsor

Kahr Bio Australia Pty Ltd

Last update posted

Aug 20, 2026

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Kahr Bio Australia Pty Ltd on 2026-08-20.