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

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: DSP107 + Atezolizumab; Drug: Fruquintinib

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.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Adam Foley Comer; Phone Number: +972 54 749 1753; Email: adam@kahrbio.com

Study Locations

• Australia
  • Adelaide
    • Woodville, Adelaide, Australia, 5011
      • Recruiting
      • The Queen Elizabeth Hospital
      • Principal Investigator: Timothy Jay Price, Dr
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Recruiting
      • Chris O'Brien Lifehouse
      • Principal Investigator: Sarah Isabella MacKenzie Sutherland, Dr
    • Westmead, New South Wales, Australia, 2145
      • Recruiting
      • Westmead Hospital
      • Principal Investigator: Adnan Mahmood Nagrial, Associate Professor
  • Queensland
    • South Brisbane, Queensland, Australia, 4101
      • Recruiting
      • Icon Cancer Centre
      • Principal Investigator: Jermaine lan George Coward, A/Prof
  • South Australia
    • Bedford Park, South Australia, Australia, 5042
      • Recruiting
      • Flinders Medical Centre SA
      • Principal Investigator: Christos Stelios Karapetis, Prof
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Recruiting
      • Monash Health
      • Principal Investigator: David Kar Wah Lau, Dr
    • Footscray, Victoria, Australia, 3011
      • Recruiting
      • Footscray Hospital - Western Health
      • Principal Investigator: Peter Gibbs, Prof
    • Heidelberg, Victoria, Australia, 3084
      • Recruiting
      • Austin Health
      • Principal Investigator: Niall Christopher Tebbutt, Prof
    • Melbourne, Victoria, Australia, 3004
      • Recruiting
      • Alfred Hospital
      • Principal Investigator: Andrew Mark Meurisse Haydon, Dr
    • Saint Albans, Victoria, Australia, 3021
      • Recruiting
      • Sunshine Hospital - Western Health
      • Principal Investigator: Peter Gibbs, Prof
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Recruiting
      • Sir Charles Gairdner Hospital
      • Principal Investigator: Rajiv Narayan Shinde, Dr
• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Hospital- Anschutz Cancer Center Pavillion (ACP)
      • Principal Investigator: Hannah Robinson
    • Highlands Ranch, Colorado, United States, 80129
      • Recruiting
      • University of Colorado Cancer Center - Highlands Ranch Hospital to Recruiting 1500 Park Central Drive,
      • Principal Investigator: Hannah Robinson
  • Florida
    • Florida City, Florida, United States, 32224
      • Recruiting
      • Mayo Clinic
      • Principal Investigator: Conor O'Donnell, Dr
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University Medical Center - Duke Cancer Center
      • Principal Investigator: Nicholas DeVito
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • Recruiting
      • UPMC Hillman Cancer Center
      • Principal Investigator: Anwaar Saeed, MD
  • Texas
    • Texas City, Texas, United States, 77030
      • Recruiting
      • The University of Texas MD Anderson Cancer Center
      • Principal Investigator: Maria Pia Morelli, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

   Note: Lines of therapy are defined by disease progression between therapies. Participants who discontinue their prior regimen due to toxicity (in the absence of disease recurrence/progression) will also have their prior therapy count as one prior regimen.

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: DSP107 + Atezolizumab; DSP107 infusion begins ~30 (±10) minutes after completion of atezolizumab infusion on Day 1.
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.	Drug: Fruquintinib; 5 mg orally, once daily (with or without food), on Days 1-21 of each 28-day cycle, followed by 7 days off.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From Day 1 until date of death from any cause assessed up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	From Screening to Follow-up (30 to 90 Days Post IP)
Changes in 12-lead ECG parameters	Safety assessment based on changes from baseline in ECG intervals (PR, QRS, QT, QTc) and heart rate.	From Baseline through to end of treatment visit, an average of 6 months
Change in Overall Survival (OS)	On completion of the safety follow-up, participants will be requested to enroll on protocol DSP107_SFU ("Observational, long-term survival follow-up study of participants previously treated in DSP107 interventional study") to allow determination of overall survival. After receiving written informed consent, all participants will be followed for up to 5 years on the DSP107_SFU study.	From randomization through study participation, with survival follow-up for up to 5 years in the DSP107_SFU study.
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).	From Baseline through to end of treatment visit, an average of 6 months
Change from Baseline in Systolic and Diastolic Blood Pressure	Mean change from baseline in blood pressure (mmHg).	From Baseline through to end of treatment visit, an average of 6 months
Change from Baseline in Pulse Rate	Mean change from baseline in heart rate (beats per minute).	From Baseline through to end of treatment visit, an average of 6 months
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.	From Baseline through to end of treatment visit, an average of 6 months

Collaborators and Investigators

• Sponsor: Kahr Bio Australia Pty Ltd
• Collaborators: Novotech (Australia) Pty Limited

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: November 3, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 19, 2025

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms; atezolizumab; HMPL-013
• Other Study ID Numbers: DSP107_003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No