DSP107 + Atezolizumab for Solid Tumors
Recruiting in Palo Alto (17 mi)
+6 other locations
Overseen ByJun Zhang, MD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Waitlist Available
Sponsor: Kahr Medical
No Placebo Group
Breakthrough Therapy
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.
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.
12345What 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.
12346Is 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.
12347Eligibility 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
I am fully active or can carry out light work.
You must have a disease that can be measured using specific guidelines.
My lung cancer is confirmed, advanced, and cannot be removed by surgery.
My cancer does not have common mutations like ALK or EGFR, but mutations like KRAS are okay.
I've had 2 or fewer treatments for my condition, excluding specific targeted therapies.
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
Treatment with Atezolizumab, Lonsurf, Regorafenib, any CD47/SIRPα targeting agent or immune agonists (e.g., anti-CD137, anti-CD40, anti-OX40)
Participant Groups
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.
5Treatment groups
Experimental Treatment
Group I: DSP107 monotherapy in colorectal cancerExperimental Treatment1 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 tumorsExperimental Treatment1 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 cancerExperimental Treatment2 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 cancerExperimental Treatment2 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 tumorsExperimental Treatment2 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
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
SKCC-Sidney Kimmel Cancer Center Thomas Jefferson UniversityPhiladelphia, PA
Moores Cancer Center, UCSDLa Jolla, CA
Indiana University Simon Cancer CenterIndianapolis, IN
UPMC Hillman Cancer Center University of PittsburghPittsburgh, PA
More Trial Locations
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Who is running the clinical trial?
Kahr MedicalLead Sponsor
References
Atezolizumab: First Global Approval. [2019]Atezolizumab (Tecentriq™)-a monoclonal antibody targeting programmed death ligand 1 (PD-L1 or CD274 antigen)-is being developed by Genentech as treatment for a variety of haematological malignancies and solid tumours. It been approved in the US as a second-line therapy for urothelial carcinoma and is awaiting approval as a second-line therapy for non-small cell lung cancer. This article summarizes the milestones in the development of atezolizumab leading to this first approval for urothelial carcinoma.
Atezolizumab as the First Systemic Therapy Approved for Alveolar Soft Part Sarcoma. [2023]The objective was to review the pharmacology, efficacy, and safety of atezolizumab (Tecentriq) for the treatment of adult and pediatric patients aged 2 years and older with unresectable or metastatic alveolar soft part sarcoma (ASPS).
Atezolizumab for use in PD-L1-positive unresectable, locally advanced or metastatic triple-negative breast cancer. [2020]Since the US FDA-approval of the first immune checkpoint inhibitor, anticytotoxic T-lymphocyte antigen-4 monoclonal antibody ipilimumab, for metastatic melanoma on 28 March 2011, another six agents have been granted use among a multitude of tumors, including renal cell cancer, Hodgkin lymphoma, urothelial carcinoma and non-small-cell lung cancer. The first anti-programmed cell death ligand-1 monoclonal antibody to receive the FDA approval, atezolizumab (Tecentriq®), has yielded promising results among international Phase III trials in triple-negative breast cancer and small-cell lung cancer, expanding the field of cancer immunotherapies. Herein, we review the pharmacodynamic and pharmacokinetic properties of atezolizumab, its safety and efficacy data from early clinical trials and summarize data from Phase III IMpassion130 trial, prompting FDA and EMA approval of atezolizumab in metastatic triple-negative breast cancer. Finally, implications for clinical use and ongoing research will be briefly discussed.
The safety of atezolizumab plus chemotherapy for the treatment of metastatic lung cancer. [2022]Atezolizumab is a humanized monoclonal antibody against PD-L1 capable of enhancing antitumor immune activity, with a demonstrated activity as single agent in patients with advanced non-small-cell lung cancer (NSCLC).
Atezolizumab First-Line Combination Therapy: A Review in Metastatic Nonsquamous NSCLC. [2020]Atezolizumab (Tecentriq®), a humanized, anti-programmed cell death ligand-1 (PD-L1) monoclonal antibody, in combination with bevacizumab, carboplatin and paclitaxel (ABCP) or with carboplatin and nab-paclitaxel (ACnP) has been approved as first-line treatment for metastatic nonsquamous NSCLC, based on results from the randomized IMpower150 and IMpower130 studies in chemotherapy-naïve patients with nonsquamous metastatic NSCLC. In IMpower150, ABCP prolonged progression-free survival (PFS) and overall survival (OS) relative to BCP, regardless of EGFR or ALK status, liver metastases at baseline or PD-L1 expression levels. In IMpower130, ACnP prolonged PFS and OS relative to CnP in patients without EGFR or ALK genetic aberrations. ABCP and ACnP had manageable tolerability profiles, which were consistent with the profile of the individual components of the regimen. Immune-related adverse events with ABCP and ACnP were largely mild or moderate in severity, and most were reversible with interruption of atezolizumab and initiation of appropriate treatment. Current evidence indicates that ABCP and ACnP are valuable emerging first-line treatment options for metastatic nonsquamous NSCLC.
Safety, Clinical Activity, and Biological Correlates of Response in Patients with Metastatic Melanoma: Results from a Phase I Trial of Atezolizumab. [2020]Atezolizumab [anti-programmed death-ligand 1 (PD-L1)] selectively targets PD-L1 to block its interaction with receptors programmed death 1 and B7.1, thereby reinvigorating antitumor T-cell activity. We evaluated the long-term safety and activity of atezolizumab, along with biological correlates of clinical activity endpoints, in a cohort of patients with melanoma in an ongoing phase Ia study (NCT01375842).
Atezolizumab Monotherapy for Non-small Cell Lung Cancer Patients: An Observational Study in Ibaraki Group (ATTENTION-IBARAKI). [2023]Atezolizumab is a monoclonal antibody that targets programmed death-ligand 1 (PD-L1) expressed on cancer cells derived from various organs and antigen-presenting cells and is currently commonly used in combination with chemotherapy. We conducted a study to clarify the current status of response to atezolizumab monotherapy in clinical practice and clarify the factors that contribute to long-term response and survival.