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Advanced Solid TumorPhase 1/2NCT04440735

A Study of DSP107 Alone and in Combination with Atezolizumab for Patients with Advanced Solid Tumors

A Phase 1/2 study testing DSP107 and Atezolizumab in people with Advanced Solid Tumor and Non Small Cell Lung Cancer, run by Kahr Medical at 7 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
DSP107 and Atezolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
125 participants
Where
7 sitesUnited States
Study dates
7 Oct 2020to Sep 2025
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Subject must have measurable disease per RECIST version 1.1
  • Part 1:
  • o 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
  • Part 2, Expansion Cohort A:
  • Histologically confirmed, inoperable non-small cell lung cancer (Stage 3b or Stage 4). Squamous and non-squamous histologies are both acceptable
Show all 11Show fewer
  • Wildtype for actionable oncogenic driver mutations (e.g., ALK, EGFR, ROS1, RET, NTRK). Driver mutations for KRAS, BRAF and c-METex14skip will be allowed.
  • Received no more than 2 lines of prior systemic treatment, including anti PD-1 or anti PD-L1 therapeutic agent ± chemotherapy. Targeted therapies for KRAS, BRAF and c-METex14skip will not be counted towards the previous lines of therapy.
  • Part 2, Expansion Cohort B:
  • Histologically confirmed, inoperable microsatellite stable colorectal carcinoma (Stage 3b or Stage 4)
  • Received two previous lines of therapy including standard chemotherapy and/or targeted antibodies

Who cannot join

  • Life expectancy of ≤ 3 months
  • Central nervous system (CNS) metastases
  • Life-threatening (grade 4) immune-mediated adverse event related to prior immunotherapy
  • Immune-mediated adverse reaction that required discontinuation of prior immunotherapy
  • Past or current history of autoimmune disease or immune deficiency
  • History of autoimmune hemolytic anemia or autoimmune thrombocytopenia
Show all 20Show fewer
  • History of hematological malignancy
  • History of organ or stem cell transplantation
  • Clinically significant liver disease, including alcoholic hepatitis, cirrhosis, fatty liver disease and inherited liver disease
  • Previously treatment with CAR-T cells
  • Treatment with systemic immunosuppressive medication within 2 weeks prior to first dose of study treatment
  • Received live, attenuated vaccine within 4 weeks prior to first dose of study treatment
  • Treatment with systemic immunostimulatory agents within 4 weeks prior to first dose of study treatment
  • Treatment with atezolizumab, any CD47/SIRPα targeting agent or immune agonists (e.g., anti-CD137, anti-CD40, anti-OX40)
  • Known allergy or hypersensitivity to any of the test compounds, materials or contraindication to test product
  • Clinically significant abnormal laboratory safety tests
  • Detection of anti DSP107 antibodies at screening
  • History of HIV infection or active Hepatitis B or C infection
  • Pregnant or breast feeding or planning to become pregnant while enrolled in the study
  • History or evidence of any other clinically unstable/uncontrolled disorder, condition, or disease

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • University of Colorado Hospital, Anschutz Cancer Pavilion (ACP)

    Aurora, Colorado, 80045

  • Indiana University Simon Cancer Center

    Indianapolis, Indiana, 46202

  • KUCC / KUMCRI University of Kansas Cancer Center

    Kansas City, Kansas, 66204

  • Moores Cancer Center, UCSD

    La Jolla, California, 92093

  • Florida Cancer Specialists

    Lake Mary, Florida, 32746

  • SKCC-Sidney Kimmel Cancer Center Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • UPMC Hillman Cancer Center University of Pittsburgh

    Pittsburgh, Pennsylvania, 15232

Other trials in United States

About this study

Official title: A First-in-Human, Two-Part, Open-Label, Phase I/II Study of DSP107 in Subjects with Advanced Solid Tumors Including a Dose-escalation Safety Study (part 1) and Preliminary Efficacy Assessment of DSP107 As Monotherapy and in Combination with Atezolizumab (part 2)

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.

Read the detailed description

This study will be the first time that DSP107 is administered to human subjects. The aim of the study is to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of DSP107 monotherapy and combination therapy in a two-part design.

Part 1 will involve DSP107 monotherapy dose escalation in subjects with advanced solid tumors that are not amenable to surgical resection or other approved therapeutic options that have demonstrated clinical benefit. Additional dose finding cohorts will be enrolled to establish a safe dose of DSP107 when given in combination with atezolizumab.

Part 2 will comprise two expansion cohorts:

  1. Expansion cohort A consisting of one treatment arm in which subjects will be treated with DSP107 in combination with atezolizumab. This expansion cohort will enroll subjects with non small cell lung cancer who have progressed following no more than 2 lines of prior systemic treatment including treatment with PD-1 or PD-L1 targeting agents.
  2. Expansion cohort B consisting of two treatment arms in which subjects will be treated either with DSP107 monotherapy or DSP107 in combination with atezolizumab. This expansion cohort will enroll subjects with colorectal cancer who have progressed following two previous lines of therapy.
Being tested
DSP107, Atezolizumab
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DSP107Biological

    DSP107 (SIRPα - 4-1BBL) is a bi-functional, trimeric, fusion protein.

  • AtezolizumabBiological

    Atezolizumab is a humanized IgG1 monoclonal antibody that targets PD-L1

Study groups in NCT04440735
Study groupRoleWhat they receive
DSP107 monotherapy in advanced solid tumorsExperimentalDSP107 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.
Receives: Biological: DSP107
DSP107 in combination with atezolizumab in advanced solid tumorsExperimentalDSP107 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.
Receives: Biological: DSP107; Biological: Atezolizumab
DSP107 in combination with atezolizumab in non-small cell lung cancerExperimentalDSP107 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.
Receives: Biological: DSP107; Biological: Atezolizumab
DSP107 monotherapy in colorectal cancerExperimentalDSP107 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..
Receives: Biological: DSP107
DSP107 in combination with atezolizumab in colorectal cancerExperimentalDSP107 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.
Receives: Biological: DSP107; Biological: Atezolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse Events (AEs)

    An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

    Measured: Duration of the study, estimated to be 9 months

  2. Dose Limiting Toxicities (DLT)

    A DLT is defined as a clinically significant AE of laboratory abnormality that is related to DSP107 or the combination of DSP107 and atezolizumab, but is unrelated to disease progression, intercurrent illness or concomitant medications

    Measured: At the end of Treatment Cycle 1 (each cycle is 21 days)

  3. DSP107 Serum Concentration

    Serum samples will be collected to determine circulating levels and PK profile of DSP107

    Measured: At the end of Treatment Cycle 8 (each cycle is 21 days)

Secondary outcomes (3)

  1. DSP107 Effect on Phenotypic and Activation Profiles of Peripheral Blood Mononuclear Cells

    Blood samples will be collected and examined by flow cytometry to determine the effect of DSP107 on different T-cells, B-cells, NK cells and monocytes, and their expression of activation markers.

    Measured: At the end of Treatment Cycle 8 (each cycle is 21 days)

  2. DSP107 and atezolizumab anti-drug antibody (ADA) formation

    Serum samples will be collected throughout the study for assessment of ADA formation using validated assay.

    Measured: Duration of the study, estimated to be 9 months

  3. Preliminary Efficacy (Part 2 only)

    Patients will undergo computed tomography (CT) scans to allow assessment of tumor response according to RECIST criteria

    Measured: Duration of the study, estimated to be 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2020
  2. Study start7 Oct 2020
  3. Primary completionSep 2025 (estimated)
  4. Study completionSep 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
Part 1 will involve sequential enrollment of patient cohorts to investigate the safety of up to 7 potential dose levels. Dose escalation will commence with up to 3 single subject cohorts before moving to a 3 + 3 dose escalation scheme to determine the maximum tolerated dose and/or recommended phase II dose. Up to 3 additional dose finding cohorts will be enrolled in parallel to the monotherapy dose escalation to establish a safe dose of DSP107 when given in combination with atezolizumab. These dose-finding combination arms will start at least one dose level below a DSP107 monotherapy dose that has already been deemed safe. Part 2 will comprise 2 expansion cohorts: Expansion cohort A will involve enrollment of patients in a single arm receiving DSP107 in combination with atezolizumab. Expansion cohort B will involve enrollment of patients randomized to receive either DSP107 monotherapy or DSP107 in combination with atezolizumab.
Masking
None (open label)
Enrolment
125 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04440735
Sponsor's protocol ID
DSP107_001
Status last verified
Jan 2025
First submitted
16 Jun 2020
Last updated
9 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing DSP107 and Atezolizumab in people with Advanced Solid Tumor and Non Small Cell Lung Cancer, run by Kahr Medical at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (AEs) (time frame: Duration of the study, estimated to be 9 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04440735.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025.

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