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Colorectal CancerPhase 2NCT07235293

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

A Phase 2 study testing DSP107 + Atezolizumab and Fruquintinib in people with Colorectal Cancer, run by Kahr Bio Australia Pty Ltd at 18 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
DSP107 + Atezolizumab and Fruquintinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
18 sitesin 2 countries
Study dates
16 Jan 2026to 30 Apr 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Are ≥ 18 years of age with a life expectancy of > 3 months.
  • 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).
  • Measurable disease per RECIST v1.1.

Who cannot join

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

Trial locations and contacts

18 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Adam Foley Comer contact

+972 54 749 1753

adam@kahrbio.com

18 sites in 2 countries

Australia12 sites, 12 recruiting

  • Flinders Medical Centre SA

    Bedford Park, South Australia, 5042

    Christos Stelios Karapetis, Prof

    Recruiting

  • Chris O'brien Lifehouse

    Camperdown, New South Wales, 2050

    Sarah Isabella MacKenzie Sutherland, Dr

    Recruiting

  • Monash Health

    Clayton, Victoria, 3168

    David Kar Wah Lau, Dr

    Recruiting

  • Footscray Hospital - Western Health

    Footscray, Victoria, 3011

    Peter Gibbs, Prof

    Recruiting

  • Austin Health

    Heidelberg, Victoria, 3084

    Niall Christopher Tebbutt, Prof

    Recruiting

  • Alfred Hospital

    Melbourne, Victoria, 3004

    Andrew Mark Meurisse Haydon, Dr

    Recruiting

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009

    Rajiv Narayan Shinde, Dr

    Recruiting

  • Port Macquarie Base Hospital (Mid North Coast Cancer Institute), Wrights Road,

    Port Macquarie, New South Wales, 2444

    Dr Stephen Donald Begbie

    Recruiting

  • Sunshine Hospital - Western Health

    Saint Albans, Victoria, 3021

    Peter Gibbs, Prof

    Recruiting

  • Icon Cancer Centre

    South Brisbane, Queensland, 4101

    Jermaine lan George Coward, A/Prof

    Recruiting

  • Westmead Hospital

    Westmead, New South Wales, 2145

    Adnan Mahmood Nagrial, Associate Professor

    Recruiting

  • The Queen Elizabeth Hospital

    Woodville, Adelaide, 5011

    Timothy Jay Price, Dr

    Recruiting

Other trials in Australia

United States6 sites, 6 recruiting

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

    Aurora, Colorado, 80045

    Hannah Robinson

    Recruiting

  • Duke University Medical Center - Duke Cancer Center

    Durham, North Carolina, 27710

    Nicholas DeVito

    Recruiting

  • Mayo Clinic

    Florida City, Florida, 32224

    Conor O'Donnell, Dr

    Recruiting

  • University of Colorado Cancer Center - Highlands Ranch Hospital

    Highlands Ranch, Colorado, 80129

    Hannah Robinson

    Recruiting

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

    Anwaar Saeed, MD

    Recruiting

  • The University of Texas MD Anderson Cancer Center

    Texas City, Texas, 77030

    Maria Pia Morelli, MD

    Recruiting

Other trials in United States

About this study

Official title: A Randomized, Open-label, Phase 2b Study to Compare the Efficacy of DSP107 in Combination With Atezolizumab Versus Fruquintinib in Patients With Advanced Microsatellite Stable Colorectal Cancer

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.

Read the detailed description

This Phase 2b, randomized, open-label, multicenter study will enroll participants with advanced MSS or mismatch repair-proficient (pMMR) colorectal cancer who have progressed on, or shown intolerance to, standard therapies, including fluoropyrimidine, irinotecan, oxaliplatin, trifluridine/tipiracil (Lonsurf), bevacizumab, and epidermal growth factor receptor (EGFR) inhibitors if RAS wild-type. Participants with BRAF V600E mutation, HER2 amplification/overexpression, KRAS G12C mutation, RET fusion, or NTRK fusion may also have received one prior targeted therapy. Prior treatment with fruquintinib or regorafenib is not allowed.

Participants will be randomized 1:1 into two arms:

Group A (Experimental): DSP107 10 mg/kg intravenously on Days 1, 8, and 15 of each 28-day cycle, administered after atezolizumab 1680 mg IV on Day 1 of each cycle. DSP107 infusion may be shortened after initial tolerance. Atezolizumab infusion may be shortened from 60 to 30 minutes if well tolerated.

Group B (Active Comparator): Fruquintinib 5 mg orally once daily on Days 1-21 of each 28-day cycle, with dosing diaries maintained by participants.

Total duration of study participation for each participant will vary based on factors including treatment tolerability, disease progression and other study discontinuation criteria.

Study duration for participants will include at least:

  • Screening Period of up to 28 days
  • Treatment Period of up to 24 cycles of 28 days
  • Safety Follow-up Period of up to 90 days* from the last dose of IP or active comparator.
  • LTFU for a period of up to 5 years from randomization.
Being tested
DSP107 + Atezolizumab, Fruquintinib
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DSP107 + AtezolizumabDrug

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

  • FruquintinibDrug

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

Study groups in NCT07235293
Study groupRoleWhat they receive
DSP107 in combination with AtezolizumabExperimentalDSP107 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.
Receives: Drug: DSP107 + Atezolizumab
FruquintinibActive comparatorParticipants will receive fruquintinib orally in 28-day cycles, for up to 24 cycles (96 weeks), or until disease progression, unacceptable toxicity, or study withdrawal.
Receives: Drug: Fruquintinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To determine Median overall survival (mOS) in participants treated with the combination of DSP107 and atezolizumab versus fruquintinib.

    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.

    Measured: From Day 1 until date of death from any cause assessed up to 2 years

Secondary outcomes (7)

  1. Incidence and severity of adverse events (AEs)

    Safety and tolerability of DSP107 + atezolizumab versus fruquintinib, assessed by incidence and severity of AEs per CTCAE v5.0 (including SAEs and AESIs).

    Measured: From Screening to Follow-up (30 to 90 Days Post IP)

  2. Changes in 12-lead ECG parameters

    Safety assessment based on changes from baseline in ECG intervals (PR, QRS, QT, QTc) and heart rate.

    Measured: From Baseline through to end of treatment visit, an average of 6 months

  3. Change in Overall Survival (OS)

    All randomized participants will continue to the LTFU phase of the study to allow determination of overall survival

    Measured: From randomization through study participation, with survival follow up at approximately 4-month (± 1 month) intervals for up to 5 years from randomization

  4. Change from Baseline in Quality of Life (QoL)

    Evaluation of the effect of treatment on quality of life (QoL) using the Functional Assessment of Cancer Therapy - Colorectal (FACT-C).

    Measured: From Baseline through to end of treatment visit, an average of 6 months

  5. Change from Baseline in Systolic and Diastolic Blood Pressure

    Mean change from baseline in blood pressure (mmHg).

    Measured: From Baseline through to end of treatment visit, an average of 6 months

  6. Change from Baseline in Pulse Rate

    Mean change from baseline in heart rate (beats per minute).

    Measured: From Baseline through to end of treatment visit, an average of 6 months

  7. To evaluate the immunogenicity of DSP107 when administered in combination with atezolizumab.

    Immunogenicity will be assessed by measurement of anti-drug antibodies (ADAs) to DSP107 in serum samples collected at specified time points.

    Measured: From Baseline through to end of treatment visit, an average of 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2025
  2. Study start16 Jan 2026
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07235293
Sponsor's protocol ID
DSP107_003
Status last verified
Sep 2025
First submitted
3 Nov 2025
Last updated
20 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DSP107 + Atezolizumab and Fruquintinib in people with Colorectal Cancer, run by Kahr Bio Australia Pty Ltd at 18 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Australia, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Adam Foley Comer (+972 54 749 1753, adam@kahrbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07235293.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.

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