A Study to Test DSP107 in Combination With Atezolizumab in Comparison With Fruquintinib as a New Treatment for Colorectal Cancer.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DSP107 + Atezolizumab, Fruquintinib.
- Who it may be relevant to
- Registry conditions: Colorectal Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized, Open-label, Phase 2b Study to Compare the Efficacy of DSP107 in Combination With Atezolizumab Versus Fruquintinib in Patients With Advanced Microsatellite Stable Colorectal Cancer
Overview
This clinical study is testing whether a new combination of medicines (DSP107 and atezolizumab) is more effective and safer than an existing treatment (fruquintinib) for people with advanced colorectal cancer that is microsatellite stable (MSS). Participants will be randomly assigned to receive one of the two treatments, and researchers will monitor how well the cancer responds, how safe the treatments are, and how the body processes them. The study hopes to show that the new combination can improve outcomes for patients with this type of colorectal cancer.
Detailed description
This Phase 2b, randomized, open-label, multicenter study will enroll participants with advanced MSS or mismatch repair-proficient (pMMR) colorectal cancer who have progressed on, or shown intolerance to, standard therapies, including fluoropyrimidine, irinotecan, oxaliplatin, trifluridine/tipiracil (Lonsurf), bevacizumab, and epidermal growth factor receptor (EGFR) inhibitors if RAS wild-type. Participants with BRAF V600E mutation, HER2 amplification/overexpression, KRAS G12C mutation, RET fusion, or NTRK fusion may also have received one prior targeted therapy. Prior treatment with fruquintinib or regorafenib is not allowed.
Participants will be randomized 1:1 into two arms:
Group A (Experimental): DSP107 10 mg/kg intravenously on Days 1, 8, and 15 of each 28-day cycle, administered after atezolizumab 1680 mg IV on Day 1 of each cycle. DSP107 infusion may be shortened after initial tolerance. Atezolizumab infusion may be shortened from 60 to 30 minutes if well tolerated.
Group B (Active Comparator): Fruquintinib 5 mg orally once daily on Days 1-21 of each 28-day cycle, with dosing diaries maintained by participants.
Total duration of study participation for each participant will vary based on factors including treatment tolerability, disease progression and other study discontinuation criteria.
Study duration for participants will include at least:
* Screening Period of up to 28 days * Treatment Period of up to 24 cycles of 28 days * Safety Follow-up Period of up to 90 days\* from the last dose of IP or active comparator. * LTFU for a period of up to 5 years from randomization.
Interventions
- Drug DSP107 + Atezolizumab
DSP107 infusion begins \~30 (±10) minutes after completion of atezolizumab infusion on Day 1. - Drug Fruquintinib
5 mg orally, once daily (with or without food), on Days 1-21 of each 28-day cycle, followed by 7 days off.
Primary outcome measures
- To determine Median overall survival (mOS) in participants treated with the combination of DSP107 and atezolizumab versus fruquintinib. [Time frame: From Day 1 until date of death from any cause assessed up to 2 years]
Secondary outcome measures (7)
- Incidence and severity of adverse events (AEs) [Time frame: From Screening to Follow-up (30 to 90 Days Post IP)]
- Changes in 12-lead ECG parameters [Time frame: From Baseline through to end of treatment visit, an average of 6 months]
- Change in Overall Survival (OS) [Time frame: From randomization through study participation, with survival follow up at approximately 4-month (± 1 month) intervals for up to 5 years from randomization]
- Change from Baseline in Quality of Life (QoL) [Time frame: From Baseline through to end of treatment visit, an average of 6 months]
- Change from Baseline in Systolic and Diastolic Blood Pressure [Time frame: From Baseline through to end of treatment visit, an average of 6 months]
- Change from Baseline in Pulse Rate [Time frame: From Baseline through to end of treatment visit, an average of 6 months]
- To evaluate the immunogenicity of DSP107 when administered in combination with atezolizumab. [Time frame: From Baseline through to end of treatment visit, an average of 6 months]
Eligibility criteria
Inclusion criteria
- Are ≥ 18 years of age with a life expectancy of > 3 months.
- Participants with histologically confirmed, inoperable, MSS and/or pMMR CRC which has progressed to, or is intolerant to, specified therapies (and has received prior treatment with no more than 3 lines of therapy).
- Measurable disease per RECIST v1.1.
Exclusion criteria
- Central nervous system (CNS) metastases unless stable 2 months post definitive therapy with steroids.
- Unresolved AEs of Grade 2 or higher from prior anticancer therapy.
- Past or current history of autoimmune disease or immune deficiency.
- History of other malignancy within 3 years of first study treatment cycle.
- Current or recent treatment with certain therapies including specified anticancer treatments, modulators of CYP3A4 and immunomodulating therapies (prior treatment with CPIs is not exclusory).
- Known allergy or hypersensitivity to any of the test compounds, materials, or contraindication to test product.
- Clinically significant abnormal laboratory safety tests.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Australia · 11 centers
- The Queen Elizabeth Hospital — Woodville
- Chris O'brien Lifehouse — Camperdown
- Westmead Hospital — Westmead
- Icon Cancer Centre — South Brisbane
- Flinders Medical Centre SA — Bedford Park
- Monash Health — Clayton
- Footscray Hospital - Western Health — Footscray
- Austin Health — Heidelberg
- … and 3 more centers
United States · 6 centers
- University of Colorado Hospital- Anschutz Cancer Center Pavillion (ACP) — Aurora
- University of Colorado Cancer Center - Highlands Ranch Hospital — Highlands Ranch
- Mayo Clinic — Florida City
- Duke University Medical Center - Duke Cancer Center — Durham
- UPMC Hillman Cancer Center — Pittsburgh
- The University of Texas MD Anderson Cancer Center — Texas City
Identifiers
NCT: NCT07235293 · DSP107_003