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Clinical Trials in Australia / NCT07235293
Recruiting Phase 2

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 Australia 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 + AtezolizumabAll DSP107 trials (2) →All Atezolizumab trials (176) →Fruquintinib →

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
No
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)

FacilityCityRegionStatus
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

A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-6036 Alone or in Combination in Participants With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation Active, not recruiting
Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions) Active, not recruiting
A Clinical Study of MK-2870 Alone or With Other Treatments to Treat Gastrointestinal Cancers (MK-9999-02A) Recruiting
Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Advanced Solid Tumors Receiving Intravenous (IV) ABBV-400 as Monotherapy and in Combination With IV Bevacizumab Active, not recruiting
RESOLUTE Trial Aims to Investigate the Value of Adding Local Ablative Treatment to Standard Systemic Treatment for Unresectable Oligometastatic Colorectal Cancer Active, not 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 Australia