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Closed (no longer recruiting)Last updated: 25 January 2024

CT898: This phase I trial is comparing a biological therapy (MEDI5083) alone and in combination with an immunotherapy agent (Durvalumab) for the treatment of select advanced cancersA Phase 1 First Time in Human Study to Evaluate the Safety, Pharmacokinetics and Immunogenicity of MEDI5083 Alone and in Combination With Durvalumab in Selected Advanced Solid Tumors

Clinical summary

Summary

This is a global Phase 1, first-time-in-human, multicenter, open-label, dose-escalation and dose-expansion study of MEDI5083 alone and in combination with durvalumab.

Conditions

This trial is treating patients with advanced solid cancers.

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

Trial Acronym

CT898

More information

Trial Identifiers

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Trial sponsor

MedImmune, LLC

Scientific Title

A Phase 1 First Time in Human Study to Evaluate the Safety, Pharmacokinetics and Immunogenicity of MEDI5083 Alone and in Combination With Durvalumab in Selected Advanced Solid Tumors

Eligibility

Inclusion

  1. Age ≥ 18 years at the time of screening or age of consent according to local law
  2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  3. Histologically or cytologically confirmed metastatic or recurrent tumor types
  4. Subjects who have received prior immunotherapy may be eligible
  5. Subjects must have at least one measurable lesion
  6. Consent to provide archival tumor tissue and pre/on-treatment biopsies
  7. Adequate organ and marrow function
  8. Consent to use one highly effective method of contraception

Exclusion

  1. Receipt of any systemic anticancer therapy within 28 days prior to the first dose of MEDI5083
  2. Concurrent enrollment in another clinical study
  3. Active/prior autoimmune of inflammatory disorders
  4. History of immunodeficiency, solid organ transplant, or tuberculosis
  5. Known allergy/hypersensitivity to drug or components
  6. Untreated central nervous system (CNS) metastatic disease, leptomeningeal disease, or cord compression
  7. Current or prior use of immunosuppressive medication within 14 days prior to the first dose of MEDI5083

Inclusion

  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
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Clinical trials have complex eligibility criteria.

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