An Open-Label, Multicenter, Randomized, Dose-Escalation and Extension, Phase IA/IB Study to Evaluate Safety and Anti-Tumor Activity of RO7284755, A PD-1 Targeted IL-2 Variant (IL-2V) Immunocytokine, Alone or in Combination With Atezolizumab in Participants With Advanced and/or Metastatic Solid Tumors

Study Identifier:
BP41628
CT.gov Identifier:
NCT04303858
EudraCT Identifier:
2019-004022-25
EU Trial (CTIS) Number:
2023-503749-76-00
Study Contact Information:
(210) 593-5651 or [email protected]
Study Complete

Considering participating in a START clinical trial?

Get Started

Study Summary

To assess the effects of eciskafusp alfa (RO7284755) as a single agent and in combination with atezolizumab in adult participants with solid tumors considered responsive to checkpoint inhibition blockade. The maximum duration in the study for each participant will be up to 28 months.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Solid Tumor
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Eciskafusp Alfa as a Single Agent
    • Read More
  • Drug: Drug: Eciskafusp Alfa
  • Drug: Experimental: Eciskafusp Alfa in Combination with Atezolizumab
  • Drug: Drug: Atezolizumab
  • Drug: Experimental: Eciskafusp Alfa as a Single Agent and/or with Atezolizumab
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Study Complete

    Requirements information
    Inclusion criteria
    • Locally advanced/unresectable or metastatic disease
    • No standard of care (SoC) (approved) treatments are available for the participant, or the participant cannot tolerate such treatments
    • Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
    • Eastern Cooperative Oncology Group Performance Status 0 to 1
    • Life expectancy of > or =12 weeks, informed by Royal Marsden Score of < or =1
    • Consent to provide an archival tumor tissue sample
    • Adequate cardiovascular, hematological, coagulative, hepatic and renal function
    Exclusion criteria
    • Rapid disease progression or suspected hyperprogression or threat to vital organs or critical anatomical sites requiring urgent alternative medical intervention
    • Known active central nervous system (CNS) metastases
    • Untreated central nervous system (CNS) metastases
    • Treated asymptomatic CNS metastases
    • Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for > or = 2 weeks before Cycle1 Day 1 (C1D1)
    • Active or history of carcinomatous meningitis/leptomeningeal disease
    • Uncontrolled tumor-related pain or symptomatic hypercalcemia
    • Concurrent second malignancy
    • Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results
    • Episode of significant cardiovascular/cerebrovascular acute disease within 28 days before study treatment administration
    • Active or uncontrolled infections
    • Known HIV infection
    • Hepatitis B virus (HBV) or hepatitis C virus infection
    • Adverse events related to any prior radiotherapy, chemotherapy, targeted therapy, CPI therapy or surgical procedure must have resolved to Grade < or =1, except alopecia Grade 2 peripheral neuropathy, and hypothyroidism and/or hypopituitarism on a stable dosage of hormone replacement therapy
    • Participants with bilateral pleural effusion
    • Major surgery or significant traumatic injury < 28 days before study treatment administration or anticipation of the need for major surgery during study treatment
    • Known allergy or hypersensitivity to any component of the formulations of the IMPs to be administered, including but not limited to hypersensitivity to Chinese hamster ovary cell products or other recombinant or humanized antibodies
    • History of severe allergic anaphylactic reactions to chimeric, human or humanized antibodies, or fusion proteins2
    • Previous treatment with Interleukin-2 (IL-2)/Interleukin-5 (IL-15)-like cytokines. IL-2/IL-15 use as an adjunct treatment component for adoptive cell therapy is permitted. In Part 3, patients who have received adoptive cell therapy such as tumor-infiltrating lymphocytes (TIL) are excluded.

    Clinical Study Information for Healthcare Providers

    By clicking the button below you will find in-depth information about this clinical trial, including study design, primary and secondary endpoints, and more. This information is intended for healthcare professionals seeking to review the scientific and operational aspects of the study.

    View Study Information

    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Madrid, Spain (FJD)
    Madrid, Spain, 28040
    Investigator
    Victor Moreno Garcia
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Solid Tumor