DSP107 + Atezolizumab for Solid Tumors

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

125 Participants Needed

Trial Summary

What is the purpose of this trial?

Part 1: A first-in-human, open-label, Phase I dose escalation study of DSP107 monotherapy and combination therapy with atezolizumab in patients with advanced solid tumors. Part 2: Preliminary efficacy assessment of DSP107 in combination with atezolizumab in second or third line treatment of non small cell lung cancer. Preliminary efficacy assessment of DSP107 as a single agent or in combination with atezolizumab in third line treatment of colorectal cancer.

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.

What data supports the idea that DSP107 + Atezolizumab for Solid Tumors is an effective treatment?

The available research shows that Atezolizumab, when used in combination with other treatments, has been effective for various types of cancer, such as lung cancer and breast cancer. For example, in studies like IMpower150 and IMpower130, Atezolizumab combined with other drugs improved survival rates for patients with lung cancer. However, there is no specific data provided here about DSP107 combined with Atezolizumab for solid tumors, so we can't directly compare its effectiveness to other treatments based on this information. ^{1 2 3 4 5}

What data supports the effectiveness of the drug Atezolizumab in treating solid tumors?

Atezolizumab has shown effectiveness in treating various cancers, including urothelial carcinoma, non-small cell lung cancer, and triple-negative breast cancer, by enhancing the body's immune response to fight cancer cells. ^{1 2 3 4 5}

What safety data is available for DSP107 and Atezolizumab treatment?

The safety data for Atezolizumab (Tecentriq) is well-documented across various studies and trials. It has been evaluated for safety in multiple cancer types, including urothelial carcinoma, non-small cell lung cancer, triple-negative breast cancer, alveolar soft part sarcoma, and melanoma. Atezolizumab has shown a consistent safety profile as a single agent and in combination with chemotherapy. However, specific safety data for the combination of DSP107 and Atezolizumab is not detailed in the provided research. ^{1 2 3 4 6}

Is the combination of DSP107 and Atezolizumab safe for humans?

Atezolizumab, also known as Tecentriq, has been studied for safety in various cancers like lung cancer, breast cancer, and melanoma, showing it can be safely used in humans. However, specific safety data for the combination of DSP107 and Atezolizumab is not available in the provided research. ^{1 2 3 4 6}

Is the drug Atezolizumab, used in the trial DSP107 + Atezolizumab for Solid Tumors, a promising treatment?

Yes, Atezolizumab is a promising drug. It has been approved for treating several types of cancer, including bladder cancer, lung cancer, and a rare type of soft tissue cancer. It works by helping the immune system fight cancer cells more effectively. This drug has shown positive results in clinical trials, making it a hopeful option for treating solid tumors. ^{1 2 3 4 7}

What makes the drug DSP107 + Atezolizumab unique for treating solid tumors?

The combination of DSP107 and Atezolizumab is unique because it combines a novel agent, DSP107, with Atezolizumab, a monoclonal antibody that targets PD-L1 (a protein that helps cancer cells evade the immune system), potentially enhancing the immune system's ability to fight solid tumors. ^{1 2 3 4 7}

Research Team

Jason Luke, MD

Principal Investigator

University of Pittsburgh

Anwaar Saeed

Principal Investigator

University of Pittsburgh

Jun Zhang, MD

Principal Investigator

KUMC

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 (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]

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, 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, 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]

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Atezolizumab: First Global Approval. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Atezolizumab as the First Systemic Therapy Approved for Alveolar Soft Part Sarcoma. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Atezolizumab for use in PD-L1-positive unresectable, locally advanced or metastatic triple-negative breast cancer. [2020]

4. England pubmed.ncbi.nlm.nih.gov

The safety of atezolizumab plus chemotherapy for the treatment of metastatic lung cancer. [2022]

5. France pubmed.ncbi.nlm.nih.gov

Atezolizumab First-Line Combination Therapy: A Review in Metastatic Nonsquamous NSCLC. [2020]

6. United States 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. [2020]

7. Greece pubmed.ncbi.nlm.nih.gov

Atezolizumab Monotherapy for Non-small Cell Lung Cancer Patients: An Observational Study in Ibaraki Group (ATTENTION-IBARAKI). [2023]