A Study to Test DSP107 in Combination With Atezolizumab in Comparison With Fruquintinib as a New Treatment for Colorectal Cancer.

NCT07235293 · tracked via the Priya Life Science USA tracker

Sponsor

Kahr Bio Australia Pty Ltd

Phase

Phase 2

Started

2026-01-16

Last updated

2026-08-20

Condition(s) studied

Colorectal Cancer

Investigational drug(s) / intervention(s)

DSP107 + AtezolizumabFruquintinib

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.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

To determine Median overall survival (mOS) in participants treated with the combination of DSP107 and atezolizumab versus fruquintinib. — From Day 1 until date of death from any cause assessed up to 2 years
Median Overall Survival (mOS) will be estimated using Kaplan-Meier methodology as the median time from the start of study treatment to the last known date a participant was alive. Censoring rules will be applied for participants without an event at the time of analysis, and 95% confidence intervals for mOS will be provided.

Trial sites (18)

Facility	City	Region	Status
University of Colorado Hospital- Anschutz Cancer Center Pavillion (ACP)	Aurora	Colorado	Recruiting
University of Colorado Cancer Center - Highlands Ranch Hospital	Highlands Ranch	Colorado	Recruiting
Mayo Clinic	Florida City	Florida	Recruiting
Duke University Medical Center - Duke Cancer Center	Durham	North Carolina	Recruiting
UPMC Hillman Cancer Center	Pittsburgh	Pennsylvania	Recruiting
The University of Texas MD Anderson Cancer Center	Texas City	Texas	Recruiting
The Queen Elizabeth Hospital	Woodville	Adelaide	Recruiting
Chris O'brien Lifehouse	Camperdown	New South Wales	Recruiting
Port Macquarie Base Hospital (Mid North Coast Cancer Institute), Wrights Road,	Port Macquarie	New South Wales	Recruiting
Westmead Hospital	Westmead	New South Wales	Recruiting
Icon Cancer Centre	South Brisbane	Queensland	Recruiting
Flinders Medical Centre SA	Bedford Park	South Australia	Recruiting
Monash Health	Clayton	Victoria	Recruiting
Footscray Hospital - Western Health	Footscray	Victoria	Recruiting
Austin Health	Heidelberg	Victoria	Recruiting
Alfred Hospital	Melbourne	Victoria	Recruiting
Sunshine Hospital - Western Health	Saint Albans	Victoria	Recruiting
Sir Charles Gairdner Hospital	Nedlands	Western Australia	Recruiting

Other trials for the same condition

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Evaluation of the ctDNA LUNAR Test in an Average Patient Screening Episode Active, not recruiting

Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Participants With Advanced KRAS G12C Mutant Solid Tumors Recruiting

Anastomotic Safety and Surveillance Using Real-time Enhanced Sensing Using xBar Recruiting

A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Colorectal Cancer Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07235293 on ClinicalTrials.gov ↗ ← All trials in the USA