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A clinical trial to look at how safe RO7284755 is at different doses and how well RO7284755 alone or together with atezolizumab works to reduce solid tumours
A Study to Evaluate Safety and Anti-Tumor Activity of RO7284755 Alone or in Combination With Atezolizumab in Participants With Advanced and/or Metastatic Solid Tumors
Cancer Solid Tumors
Basic Details
Sponsor
Hoffmann-La Roche
Phase
Phase 1
Trial Identifier
NCT04303858, BP41628, 2023-503749-76-00
Condition
Solid Tumors
Official Title
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 Summary
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.
Eligibility Criteria
All
≥18 Years
No
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 >=12 weeks
- 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
- 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 >= 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 <=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 proteins
- 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.
The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.
The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
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For the latest version of this information please go to www.forpatients.roche.com