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

NCT07235293 | Recruiting Phase 2 FDA Drug

• 1 other identifier: DSP107_003
• Study Type: interventional
• Target: 90
• Locations: 2 countries
• Sites: 16

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

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (7)

• Incidence and severity of adverse events (AEs)

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

• Changes in 12-lead ECG parameters

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

• Change in Overall Survival (OS)

  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)

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

• Change from Baseline in Systolic and Diastolic Blood Pressure

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

Study Arms (2)

DSP107 in combination with Atezolizumab

EXPERIMENTAL

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

Fruquintinib

ACTIVE COMPARATOR

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

Interventions

DSP107 + Atezolizumab DRUG

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

DSP107 in combination with Atezolizumab

Fruquintinib DRUG

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

Fruquintinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.
• Measurable disease per RECIST v1.1.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novotech (Australia) Pty Limited: collaborator
• Kahr Bio Australia Pty Ltd: lead

Study Sites (16)

University of Colarodo Cancer Center

Aurora, Colorado, 80045, United States

NOT YET RECRUITING

Mayo Clinic

Florida City, Florida, 32224, United States

NOT YET RECRUITING

Duke University Medical Center - Duke Cancer Center

Durham, North Carolina, 27710, United States

RECRUITING

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

The University of Texas MD Anderson Cancer Center

Texas City, Texas, 77030, United States

NOT YET RECRUITING

The Queen Elizabeth Hospital

Woodville, Adelaide, 5011, Australia

RECRUITING

Chris O'brien Lifehouse

Camperdown, New South Wales, 2050, Australia

RECRUITING

Westmead Hospital

Westmead, New South Wales, 2145, Australia

RECRUITING

Icon Cancer Centre

South Brisbane, Queensland, 4101, Australia

RECRUITING

Flinders Medical Centre SA

Bedford Park, South Australia, 5042, Australia

RECRUITING

Monash Health

Clayton, Victoria, 3168, Australia

RECRUITING

Footscray Hospital - Western Health

Footscray, Victoria, 3011, Australia

RECRUITING

Austin Health

Heidelberg, Victoria, 3084, Australia

RECRUITING

Alfred Hospital

Melbourne, Victoria, 3004, Australia

RECRUITING

Sunshine Hospital - Western Health

Saint Albans, Victoria, 3021, Australia

RECRUITING

Sir Charles Gairdner Hospital

Nedlands, Western Australia, 6009, Australia

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

atezolizumab; HMPL-013

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Adam Foley Comer

CONTACT

+972 54 749 1753; adam@kahrbio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2025
• First Posted: November 19, 2025
• Study Start: January 16, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: April 9, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (5); AU (11)