DSP107 + Atezolizumab for Solid Tumors

Not currently recruiting at 6 trial locations

Overseen By Alexander Philipovskiy, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Kahr Medical

Must not be taking: Immunosuppressants, Immunostimulants, Atezolizumab, others

Disqualifiers: CNS metastases, Autoimmune disease, Liver disease, others

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

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

Compensation: Varies

Number of Visits: 3

Duration: 36 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, DSP107, both alone and with atezolizumab (also known as Tecentriq, an immunotherapy), to evaluate their effects on solid tumors, particularly in lung and colorectal cancer. The goal is to determine the optimal dose and assess whether these treatments can help when other options have failed. Patients with advanced lung cancer unresponsive to standard treatments or those with colorectal cancer who have exhausted standard therapies might be suitable candidates. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering patients the opportunity to be among the first to receive this new therapy.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you must stop taking your current medications. However, you cannot take systemic immunosuppressive medication within 2 weeks before the first dose, or systemic immunostimulatory agents within 4 weeks before the first dose. Also, you cannot have received a live, attenuated vaccine within 4 weeks before the first dose.

Do I need to stop my current medications to join the trial?

The trial requires that you stop taking systemic immunosuppressive medications at least 2 weeks before starting the study treatment. If you are on systemic immunostimulatory agents, you need to stop them 4 weeks before the trial. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

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

Research has shown that DSP107 is generally safe. Tested in over 110 patients with solid tumors, many tolerated the treatment well. Some patients even experienced disease control, with tumors shrinking or disappearing.

When combined with atezolizumab, DSP107 also shows promise. Atezolizumab, already used to treat certain cancers, aims to enhance the body's defense against tumors when paired with DSP107. Studies suggest that this combination is safe and potentially beneficial.

Overall, evidence indicates that DSP107, whether used alone or with atezolizumab, is safe for many patients. However, individual experiences can vary, so discussing potential risks with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about DSP107 and atezolizumab because they offer a fresh approach to treating solid tumors, including colorectal and non-small cell lung cancer. Unlike traditional chemotherapy that attacks dividing cells indiscriminately, DSP107 is designed to target the CD47-SIRPα pathway, a mechanism that cancer cells use to evade the immune system. By combining DSP107 with atezolizumab, an immune checkpoint inhibitor that blocks the PD-L1 protein, this treatment aims to enhance the body's immune response against tumors more effectively. This combination could potentially lead to more targeted and less toxic treatment options compared to current standards of care.

What evidence suggests that this trial's treatments could be effective?

Research shows that using DSP107 with atezolizumab has yielded promising results in treating certain cancers. In this trial, participants with colorectal cancer may receive the combination of DSP107 and atezolizumab, which has controlled the disease in 62% of patients, with some experiencing complete or partial tumor shrinkage. For non-small cell lung cancer, some participants will receive atezolizumab alone, which has extended patient survival with manageable side effects. Early research suggests that adding DSP107 could enhance effectiveness. In advanced solid tumors, this trial will also explore DSP107 either alone or with atezolizumab, as initial studies suggest potential benefits, though further research is needed to confirm these findings. ^{1 2 4 6 7}

Who Is on the Research Team?

Jason Luke, MD

Principal Investigator

University of Pittsburgh

Anwaar Saeed

Principal Investigator

University of Pittsburgh

Jun Zhang, MD

Principal Investigator

KUMC

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors, including non-small cell lung cancer and colorectal cancer. Participants must have measurable disease, an ECOG status of 0 or 1, no more than two prior treatments (excluding certain targeted therapies), and cannot have a history of severe autoimmune diseases, CNS metastases, organ transplants, significant liver disease or recent immunosuppressive treatment.

Inclusion Criteria

Received two previous lines of therapy including standard chemotherapy and/or targeted antibodies

Histologically confirmed, inoperable microsatellite stable colorectal carcinoma (Stage 3b or Stage 4)

Histologically confirmed advanced solid tumor that is not amenable to surgical resection or other approved therapeutic options that have demonstrated clinical benefit or subject is intolerant or has refused available therapies

Exclusion Criteria

I do not have serious liver conditions like cirrhosis or fatty liver disease.

I haven't taken any immune-boosting drugs in the last 4 weeks.

Treatment with Atezolizumab, Lonsurf, Regorafenib, any CD47/SIRPα targeting agent or immune agonists (e.g., anti-CD137, anti-CD40, anti-OX40)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive DSP107 monotherapy or in combination with atezolizumab in 21-day cycles for up to 12 cycles

36 weeks

3 visits per cycle (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Atezolizumab
• DSP107

Trial Overview

The study tests DSP107 alone and combined with Atezolizumab in patients with advanced solid tumors. Part 1 explores the safe dosage levels while Part 2 assesses effectiveness against non-small cell lung cancer after one or two other treatments and colorectal cancer after two previous treatments.

How Is the Trial Designed?

Group I: DSP107 monotherapy in colorectal cancer Experimental Treatment 1 Intervention

DSP107 10mg/kg will be administered by intravenous infusion over 1 hour on Days 1, 8 and 15 of each 21-day cycle for up to 12 treatment cycles..

Group II: DSP107 monotherapy in advanced solid tumors Experimental Treatment 1 Intervention

DSP107 will be administered by intravenous infusion over 1 hour on Days 1, 8 and 15 of each 21-day cycle for up to 12 treatment cycles. Starting dose will be 0.01 mg/kg and maximum dose will not exceed 10 mg/kg.

Group III: DSP107 in combination with atezolizumab in non-small cell lung cancer Experimental Treatment 2 Interventions

DSP107 10mg/kg will be administered by IV infusion over 1 hour on Days 1, 8 and 15 of each 21-day cycle. Subjects will receive atezolizumab 1200 mg by intravenous infusion over 30 mins (first infusion over 1 hour) on Day 1 of every treatment cycle. DSP107 infusion will commence 1 hour following completion of atezolizumab infusion. The study will include up to 12 treatment cycles.

Group IV: DSP107 in combination with atezolizumab in colorectal cancer Experimental Treatment 2 Interventions

DSP107 10mg/kg will be administered by IV infusion over 1 hour on Days 1, 8 and 15 of each 21-day cycle. Subjects will receive atezolizumab 1200 mg by intravenous infusion over 30 mins (first infusion over 1 hour) on Day 1 of every treatment cycle. DSP107 infusion will commence 1 hour following completion of atezolizumab infusion. The study will include up to 12 treatment cycles.

Group V: DSP107 in combination with atezolizumab in advanced solid tumors Experimental Treatment 2 Interventions

DSP107 will be administered by IV infusion over 1 hour on Days 1, 8 and 15 of each 21-day cycle. Subjects will receive atezolizumab 1200 mg by intravenous infusion over 30 mins (first infusion over 1 hour) on Day 1 of every treatment cycle. DSP107 infusion will commence 1 hour following completion of atezolizumab infusion. The study will include up to 12 treatment cycles.

Atezolizumab is already approved in United States, European Union for the following indications:

Approved in United States as Tecentriq for:

• Melanoma
• Hepatocellular carcinoma
• Small cell lung cancer
• Non-small cell lung cancer
• Urothelial carcinoma

Approved in European Union as Tecentriq for:

• Melanoma
• Hepatocellular carcinoma
• Small cell lung cancer
• Non-small cell lung cancer
• Urothelial carcinoma

Who Is Running the Clinical Trial?

Kahr Medical

Lead Sponsor

Trials

3

Recruited

160+

Published Research Related to This Trial

In a study of 147 patients with advanced non-small cell lung cancer (NSCLC) treated with atezolizumab monotherapy, the average progression-free survival was 3.0 months and overall survival was 7.0 months, indicating moderate efficacy in a real-world setting.

The study found that factors such as having a performance status of 0-1 and receiving up to 3 lines of treatment were associated with better overall survival, highlighting the importance of patient characteristics in predicting treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab Monotherapy for Non-small Cell Lung Cancer Patients: An Observational Study in Ibaraki Group (ATTENTION-IBARAKI). Okauchi, S., Ohara, G., Shiozawa, T., et al.[2023]

Atezolizumab, the first anti-PD-L1 monoclonal antibody approved by the FDA, has shown promising efficacy in treating metastatic triple-negative breast cancer, supported by data from the Phase III IMpassion130 trial.

The review highlights the pharmacodynamic and pharmacokinetic properties of atezolizumab, emphasizing its safety and effectiveness in various cancers, including small-cell lung cancer and renal cell cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab for use in PD-L1-positive unresectable, locally advanced or metastatic triple-negative breast cancer. Mavratzas, A., Seitz, J., Smetanay, K., et al.[2020]

Atezolizumab, an anti-PD-L1 therapy, was well tolerated in a study of 45 patients with advanced melanoma, showing that most side effects were mild (grade 1/2) and no treatment-related deaths occurred.

The treatment resulted in a 30% overall response rate and a median overall survival of 23 months, with certain biomarkers like PD-L1 expression and tumor mutational burden linked to better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, Clinical Activity, and Biological Correlates of Response in Patients with Metastatic Melanoma: Results from a Phase I Trial of Atezolizumab. Hamid, O., Molinero, L., Bolen, CR., et al.[2020]

Atezolizumab is a monoclonal antibody that targets PD-L1, which is being developed for treating various blood cancers and solid tumors, showing promise in cancer immunotherapy.

It has already been approved in the US as a second-line treatment for urothelial carcinoma and is pending approval for non-small cell lung cancer, highlighting its potential efficacy in these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab: First Global Approval. Markham, A.[2019]

Atezolizumab, a monoclonal antibody targeting PD-L1, has shown significant improvements in progression-free and overall survival in patients with advanced non-small-cell lung cancer (NSCLC) and small-cell lung cancer (SCLC) when combined with chemotherapy, as demonstrated in the IMpower studies.

The safety profile of atezolizumab in combination with chemotherapy is acceptable, with common immune-related adverse events including rash (18-28%), hypothyroidism (8-15%), and hepatitis (5-17%), consistent with its known effects as a single agent, indicating no new safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of atezolizumab plus chemotherapy for the treatment of metastatic lung cancer. Manzo, A., Carillio, G., Montanino, A., et al.[2022]

Atezolizumab combined with chemotherapy (ABCP or ACnP) has been shown to significantly improve progression-free survival (PFS) and overall survival (OS) in chemotherapy-naïve patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), based on the IMpower150 and IMpower130 studies.

Both treatment regimens (ABCP and ACnP) demonstrated manageable safety profiles, with most immune-related side effects being mild to moderate and reversible, making them promising first-line options for this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab First-Line Combination Therapy: A Review in Metastatic Nonsquamous NSCLC. Dhillon, S., Syed, YY.[2020]

Atezolizumab (Tecentriq) is an FDA-approved treatment for unresectable or metastatic alveolar soft part sarcoma (ASPS), showing a 24% overall response rate in a clinical trial with 49 patients, and a durable response rate of 67% at 6 months and 42% at 12 months.

The treatment has a manageable safety profile, with common severe side effects including musculoskeletal pain (8%) and hypertension (6%), making it a viable option for patients with limited treatment alternatives for this high-risk disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab as the First Systemic Therapy Approved for Alveolar Soft Part Sarcoma. Bergsma, EJ., Elgawly, M., Mancuso, D., et al.[2023]

Citations

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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.

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The aim of the study is to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of DSP107 monotherapy and combination ...

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KAHR Bio Announces Positive Phase 2 Results of DSP107 ...

Findings presented in an oral presentation at the 2025 ASCO Annual Meeting. - DSP107 in combination with atezolizumab in 3rd line ...

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Phase 1 dose escalation study of DSP107, a first-in-class ...

Here we describe data from the completed DSP107 plus atezolizumab combination dose escalation portion of study NCT04440735. Methods: Adult ...

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A Study of DSP107 Alone and in Combination

The aim of the study is to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of DSP107 monotherapy and ...

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NCT04440735

A first-in-human, open-label, Phase I dose escalation study of DSP107 monotherapy and combination therapy with atezolizumab in patients with advanced solid ...

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DSP107

• Excellent and differentiated safety profile demonstrated in more than 110 solid tumor patients ... • Atezolizumab will unleash T cell cytotoxicity.