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Monoclonal Antibodies
DSP107 + Atezolizumab for Solid Tumors
Phase 1 & 2
Recruiting
Led By Jason Luke, MD
Research Sponsored by Kahr Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Subject must have measurable disease per RECIST version 1.1
Must not have
Treatment with Atezolizumab, Lonsurf, Regorafenib, any CD47/SIRPα targeting agent or immune agonists (e.g., anti-CD137, anti-CD40, anti-OX40)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up duration of the study, estimated to be 12 months
Awards & highlights
Study Summary
This trial is testing a new drug, DSP107, as a possible treatment for advanced solid tumors. The trial will assess the safety and efficacy of DSP107 given alone or in combination with atezolizumab.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects include immune system reactions that could affect various organs, infusion-related reactions similar to allergic responses during drug administration, fatigue from treatment burden on the body's energy resources, digestive disturbances like nausea or diarrhea due to gastrointestinal tract involvement.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
Select...
You must have a disease that can be measured using specific guidelines.
Select...
My lung cancer is confirmed, advanced, and cannot be removed by surgery.
Select...
My cancer does not have common mutations like ALK or EGFR, but mutations like KRAS are okay.
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I've had 2 or fewer treatments for my condition, excluding specific targeted therapies.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ duration of the study, estimated to be 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of the study, estimated to be 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse Events (AEs)
Serum
Dose Limiting Toxicities (DLT)
Secondary outcome measures
DSP107 Effect on Phenotypic and Activation Profiles of Peripheral Blood Mononuclear Cells
DSP107 and atezolizumab anti-drug antibody (ADA) formation
Preliminary Efficacy (Part 2 only)
Side effects data
From 2019 Phase 3 trial • 1225 Patients • NCT0200822736%
Fatigue
35%
Alopecia
24%
Diarrhoea
23%
Nausea
23%
Decreased appetite
22%
Anaemia
20%
Asthenia
19%
Cough
19%
Dyspnoea
16%
Myalgia
15%
Neutropenia
14%
Constipation
14%
Oedema peripheral
12%
Pyrexia
11%
Neuropathy peripheral
11%
Vomiting
11%
Stomatitis
10%
Arthralgia
9%
Rash
9%
Neutrophil count decreased
8%
Dysgeusia
8%
Paraesthesia
8%
Headache
7%
Peripheral sensory neuropathy
7%
Pain in extremity
7%
Insomnia
7%
Mucosal inflammation
7%
Back pain
6%
Pneumonia
6%
Febrile neutropenia
6%
Abdominal pain
6%
Dry skin
6%
Lacrimation increased
6%
Dizziness
5%
Haemoptysis
5%
Weight decreased
5%
Malaise
5%
Urinary tract infection
5%
Nail disorder
4%
Productive cough
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
3%
Pruritus
3%
Upper respiratory tract infection
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
2%
Influenza like illness
1%
Respiratory tract infection
1%
Musculoskeletal chest pain
1%
Lower respiratory tract infection
1%
Acute kidney injury
1%
Depression
1%
Lung infection
1%
Dehydration
1%
Chronic obstructive pulmonary disease
1%
Atrial fibrillation
1%
Syncope
1%
Pleural effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel
Atezolizumab
Trial Design
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2017
Completed Phase 3
~5860
Find a Location
Who is running the clinical trial?
Kahr MedicalLead Sponsor
2 Previous Clinical Trials
36 Total Patients Enrolled
Jason Luke, MDPrincipal InvestigatorUniversity of Pittsburgh
3 Previous Clinical Trials
646 Total Patients Enrolled
Jun Zhang, MDPrincipal InvestigatorKUMC
1 Previous Clinical Trials
197 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I have undergone two prior treatments including chemotherapy or targeted therapy.You must have a detectable and measurable disease according to specific medical guidelines.I have been treated with CAR-T cell therapy before.I am fully active or can carry out light work.My advanced cancer cannot be surgically removed, and I can't or won't use other treatments.I have not been treated with atezolizumab or drugs targeting CD47/SIRPα.My colorectal cancer is advanced and cannot be removed by surgery.You have antibodies against DSP107 when tested before the study.I have a history of HIV or active Hepatitis B or C.You have had a disease that affects your immune system in the past or currently.You have important abnormal results from safety tests in your laboratory tests.I've had 2 or fewer treatments for my condition, excluding specific targeted therapies.I do not have any uncontrolled health conditions.I am not allergic to any of the medications or materials used in the test.My lung cancer can be of any type.I am fully active or can carry out light work.My cancer does not have genetic changes that can be targeted by treatment.My lung cancer is confirmed, advanced, and cannot be removed by surgery.My cancer has spread to my brain or spinal cord.I stopped previous immunotherapy due to an immune reaction.I have had blood cancer in the past.I have had an organ or stem cell transplant.I haven't taken any immune-weakening drugs in the last 2 weeks.I have not received a live vaccine in the last 4 weeks.You are not expected to live for more than 3 months.I have had autoimmune blood disorders affecting my red cells or platelets.My cancer does not have common mutations like ALK or EGFR, but mutations like KRAS are okay.You must have a disease that can be measured using specific guidelines.I had a severe reaction to previous immunotherapy.
Research Study Groups:
This trial has the following groups:- Group 1: DSP107 in combination with atezolizumab in colorectal cancer
- Group 2: DSP107 monotherapy in advanced solid tumors
- Group 3: DSP107 in combination with atezolizumab in non-small cell lung cancer
- Group 4: DSP107 monotherapy in colorectal cancer
- Group 5: DSP107 in combination with atezolizumab in advanced solid tumors
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the upper limit on participants for this examination?
"Affirmative. Clinicaltrials.gov confirms that the trial, which was initially advertised on October 7th 2020, is actively searching for candidates. 100 individuals will be recruited from 5 different medical centres."
Answered by AI
Can you provide details of any prior research on DSP107?
"The initial studies conducted on DSP107 were completed in 2008 at SCRI Tennessee Oncology Chattanooga. Thus far, 80 trials have been concluded and 351 are presently looking for participants. Of those actively recruiting, a significant number take place within the confines of Kansas City, Kansas."
Answered by AI
Is this medical experiment a pioneering effort in its field?
"The research surrounding DSP107 commenced in 2008, with the first clinical trial conducted by Hoffmann-La Roche. After successful Phase 1 trials involving 720 participants, DSP107 was approved for use during its second phase of testing. Currently, 351 studies are actively occurring across multiple cities and countries around the world."
Answered by AI
What is the geographic spread of this research initiative?
"Currently, 5 different clinic locations are participating in this trial, located in Kansas City, Philadelphia, Aurora and two other cities. To lessen the burden of travel for participants, it is advised to select the closest location to you."
Answered by AI
Is it still feasible to enlist in this research?
"Affirmative. As per the information available on clinicaltrials.gov, this research venture is actively seeking participants. It was first published on October 7th 2020 and its most recent update occurred March 28th 2022. An estimated 100 individuals must be enrolled from 5 medical facilities to complete this trial."
Answered by AI
In what ways is DSP107 typically utilized?
"DSP107 is primarily used to combat small cell lung cancer (sclc), but it has also shown efficacy against malignant neoplasms, non-small cell lung carcinoma, and postoperative therapy."
Answered by AI
Who else is applying?
What state do they live in?
Colorado
How old are they?
65+
What site did they apply to?
University of Colorado Hospital, Anschutz Cancer Pavilion (ACP)
Indiana University Simon Cancer Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
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