For Healthcare Professionals

A Study to Evaluate Safety and Anti-Tumor Activity of Eciskafusp Alfa (RO7284755) Alone or in Combination With Atezolizumab in Participants With Advanced and/or Metastatic Solid Tumors

clipboard-pencil

About the study

This is an entry-into-human study and will 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.
user-3

Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:

  1. Locally advanced/unresectable or metastatic disease
  2. No standard of care (SoC) (approved) treatments are available for the participant, or the participant cannot tolerate such treatments
  3. Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
  4. Eastern Cooperative Oncology Group Performance Status 0 to 1
  5. Life expectancy of >=12 weeks
  6. Consent to provide an archival tumor tissue sample
  7. Adequate cardiovascular, hematological, coagulative, hepatic and renal function

EXCLUSION CRITERIA

Exclusion Criteria:

  1. Rapid disease progression or suspected hyperprogression or threat to vital organs or critical anatomical sites requiring urgent alternative medical intervention
  2. Untreated central nervous system (CNS) metastases
  3. Treated asymptomatic CNS metastases
  4. 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 >= 2 weeks before Cycle1 Day 1 (C1D1)
  5. Active or history of carcinomatous meningitis/leptomeningeal disease
  6. Uncontrolled tumor-related pain or symptomatic hypercalcemia
  7. Concurrent second malignancy
  8. Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results
  9. Episode of significant cardiovascular/cerebrovascular acute disease within 28 days before study treatment administration
  10. Active or uncontrolled infections
  11. Known HIV infection
  12. Hepatitis B virus (HBV) or hepatitis C virus infection
  13. Adverse events related to any prior radiotherapy, chemotherapy, targeted therapy, CPI therapy or surgical procedure must have resolved to Grade <=1, except alopecia Grade 2 peripheral neuropathy, and hypothyroidism and/or hypopituitarism on a stable dosage of hormone replacement therapy
  14. Participants with bilateral pleural effusion
  15. Major surgery or significant traumatic injury < 28 days before study treatment administration or anticipation of the need for major surgery during study treatment
  16. 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
  17. History of severe allergic anaphylactic reactions to chimeric, human or humanized antibodies, or fusion proteins
  18. 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.
pin location

Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

Solid Tumors

Age (in years)

18+

Phase

Phase 1

Participants needed

256

Est. Completion Date

May 27, 2027

Treatment type

Interventional


Sponsor

Hoffmann-La Roche

ClinicalTrials.gov identifier

NCT04303858

Study number

BP41628

Understanding Clinical Trials


Get answers to your questions about clinical trials.What is a clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?
Vector

Interested?

Sign up to save your favorites, 
receive newsletters, resources, and alerts 
about clinical trials related to your conditions of interest.