DSP107 + Atezolizumab for Colorectal Cancer

Not yet recruiting at 9 trial locations

Overseen By Adam Foley Comer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Kahr Bio Australia Pty Ltd

Must not be taking: CYP3A4 modulators, Immunomodulators

Disqualifiers: CNS metastases, Autoimmune disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 1

Duration: up to 96 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a new combination of medicines, DSP107 (an experimental treatment) and atezolizumab (an immunotherapy drug), can more effectively treat advanced microsatellite stable colorectal cancer (a type of cancer with few genetic changes) compared to the existing drug fruquintinib. Participants will be randomly assigned to receive either the new combination or fruquintinib to evaluate cancer response and treatment tolerance. The trial seeks individuals whose cancer has progressed despite previous treatments and who have a type of colorectal cancer that cannot be surgically removed. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not clearly state if you need to stop your current medications, but it mentions that recent treatment with certain therapies, including some anticancer treatments and immunomodulating therapies, may exclude you from participating. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the combination of DSP107 and atezolizumab is generally safe for people. A recent study found this combination safe for patients with advanced colorectal cancer, with no serious side effects affecting blood cells, the liver, or other organs. Another study confirmed that both DSP107 alone and with atezolizumab were well-tolerated, with no major safety concerns. Overall, the evidence suggests that this treatment is safe for those considering participation in this clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the DSP107 and Atezolizumab combination for colorectal cancer because it offers a novel approach compared to standard treatments like chemotherapy and those targeting specific cancer pathways. DSP107 is unique because it targets CD47, a protein that helps cancer cells evade the immune system. By combining this with Atezolizumab, an immunotherapy that boosts the body's natural defenses against cancer, the treatment has the potential to more effectively engage the immune system in fighting the tumor. This dual approach could offer improved outcomes for patients who might not respond well to existing therapies.

What evidence suggests that this trial's treatments could be effective for advanced colorectal cancer?

Research has shown that combining DSP107 and atezolizumab, which participants in this trial may receive, may help treat advanced colorectal cancer. This combination has been found to shrink or control tumor growth. In patients with a type of colorectal cancer called MSS, particularly those whose cancer has spread to the liver, the treatment stopped or reduced cancer growth in 57% of cases. More than half of the patients experienced a halt or reduction in their cancer's growth for a period of time. Early results suggest this treatment could benefit those who haven't had success with other treatments. Another treatment arm in this trial involves Fruquintinib, administered as an active comparator. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for individuals with advanced microsatellite stable (MSS) colorectal cancer. Participants should meet specific health criteria and not have received certain prior treatments. Detailed inclusion and exclusion criteria are set to ensure patient safety and clear results.

Inclusion Criteria

I am 18 or older with an expected lifespan of more than 3 months.

Participants have measurable disease per RECIST v1.1.

My colorectal cancer is confirmed, can't be removed by surgery, and has not responded well to up to 3 treatments.

Exclusion Criteria

I am not allergic to any of the materials or compounds in the test.

My brain metastases are stable and I haven't needed steroids for 2 months.

Patients with past or current history of autoimmune disease or immune deficiency

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive either DSP107 in combination with atezolizumab or fruquintinib in 28-day cycles

up to 96 weeks

In-person visits on Days 1, 8, and 15 of each cycle for DSP107 group; daily oral administration for Fruquintinib group

Safety Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 90 days

Long-term Survival Follow-up

Participants are followed for overall survival in a separate observational study

up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Atezolizumab
• DSP107
• Fruquintinib

Trial Overview The study compares a new treatment combo, DSP107 with Atezolizumab, against an existing drug, Fruquintinib, in advanced MSS colorectal cancer patients. It aims to determine which is safer and more effective by observing the body's response and side effects.

How Is the Trial Designed?

Group I: DSP107 in combination with Atezolizumab Experimental Treatment 1 Intervention

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.

Group II: Fruquintinib Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Kahr Bio Australia Pty Ltd

Lead Sponsor

Novotech (Australia) Pty Limited

Industry Sponsor

Trials

76

Recruited

7,800+

Dr. John Moller

Novotech (Australia) Pty Limited

Chief Executive Officer

MD and MBA from the University of Oxford

Dr. Judith Ng-Cashin

Novotech (Australia) Pty Limited

Chief Medical Officer since 2023

MD

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.3517

Phase 2 dose expansion study of DSP107, a first-in-class ... These data suggest that the combination of DSP107 with PD(L)1 blockade has anti-tumor activity and provides clinical benefit in third line metastatic MSS CRC.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07235293

A Study to Test DSP107 in Combination With Atezolizumab ... The study hopes to show that the new combination can improve outcomes for patients with this type of colorectal cancer. Detailed Description.

3. annalsofoncology.org annalsofoncology.org/article/S0923-7534(24)00201-1/fulltext

51P Phase II dose expansion study of DSP107, a first-in- ... These phase 2 data suggest that the combination of DSP107 with PD(L)1 blockade has anti-tumor activity in MSS CRC including in patients with liver metastases.

4. prnewswire.com prnewswire.com/il/news-releases/kahr-bio-announces-positive-phase-2-results-of-dsp107-in-combination-with-anti-pd-l1-in-colorectal-cancer-302470389.html

KAHR Bio Announces Positive Phase 2 Results of DSP107 ... Results from the completed dose expansion cohort show that DSP107 monotherapy and combination treatment with atezolizumab were well tolerated ...

5. clin.larvol.com clin.larvol.com/trial-detail/NCT04440735

A Study of DSP107 Alone and in Combination ... At the highest dose (10 mg/kg) of DSP107, which was selected for the expansion cohorts, the combined treatment demonstrated a disease control rate (DCR) of 57% ...

6. colorectalcancer.org colorectalcancer.org/sites/default/files/media/documents/2024-Cure-CRC-Summit-1-Yaron%20Pereg.pdf

DSP107 DSP107 monotherapy (n=17) and combination with Atezolizumab (n=21) tested in 3L MSS CRC patients1. • Excellent and differentiated safety profile ...