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

Part of paid clinical trials in La Jolla, California.

Sponsor
Kahr Medical
Study ID
NCT04440735
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • DSP107 — BIOLOGICAL
    DSP107 (SIRPα - 4-1BBL) is a bi-functional, trimeric, fusion protein.
  • Atezolizumab — BIOLOGICAL
    Atezolizumab is a humanized IgG1 monoclonal antibody that targets PD-L1

Study Details

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.

Key Dates

Start date
Oct 7, 2020
Status verified
Jan 2025
Primary completion
Sep 30, 2025
Completion
Sep 30, 2025

Study Design

Enrollment
125 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: DSP107 monotherapy in advanced solid tumors
    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.
  • Experimental: DSP107 in combination with atezolizumab in advanced solid tumors
    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.
  • Experimental: DSP107 in combination with atezolizumab in non-small cell lung cancer
    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.
  • Experimental: DSP107 monotherapy in colorectal cancer
    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..
  • Experimental: DSP107 in combination with atezolizumab in colorectal cancer
    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.

Primary Outcome Measure

Adverse Events (AEs) [ Time Frame: Duration of the study, estimated to be 9 months ]

Locations (7)

FacilityCityStateZIPSite coordinators
Moores Cancer Center, UCSDLa JollaCalifornia92093-
University of Colorado Hospital, Anschutz Cancer Pavilion (ACP)AuroraColorado80045-
Florida Cancer SpecialistsLake MaryFlorida32746-
Indiana University Simon Cancer CenterIndianapolisIndiana46202-
KUCC / KUMCRI University of Kansas Cancer CenterKansas CityKansas66204-
SKCC-Sidney Kimmel Cancer Center Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-
UPMC Hillman Cancer Center University of PittsburghPittsburghPennsylvania15232-

Find similar trials in La Jolla, CA

By condition
Colorectal cancerLung cancer
By specialty
OncologyGI oncologyLung oncologyLung disease
By research site
Moores Cancer Center, UCSD· La Jolla, CAUniversity of Colorado Hospital, Anschutz Cancer Pavilion (ACP)· Aurora, COFlorida Cancer Specialists· Lake Mary, FLIndiana University Simon Cancer Center· Indianapolis, INKUCC / KUMCRI University of Kansas Cancer Center· Kansas City, KSSKCC-Sidney Kimmel Cancer Center Thomas Jefferson University· Philadelphia, PA

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