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Closed (no longer recruiting)Last updated: 3 November 2023

This phase I trial is evaluating a new biological therapy (MEDI5752) alone and in combination with various chemotherapy / immunotherapy drugs for the treatment of advanced solid cancersA Phase 1, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of MEDI5752 in Subjects With Advanced Solid Tumors

Clinical summary

Summary

In this trial, participants will be randomized into one of four groups.

In group A, participants will receive the new therapy, MEDI5752, alone.

In group B, participants will receive an immunotherapy drug, durvalumab, alone.

In group C, participants will receive the new therapy, MEDI5752, in combination with two chemotherapy drugs, pemetrexed and carboplatin.

In group D, participants will receive an immunotherapy drug, pembrolizumab, in combination with two chemotherapy drugs, pemetrexed and carboplatin.

Conditions

This trial is treating patients with advanced solid cancers (excluding blood cancers).

Cancer

Multi-Cancer Multi-Cancer

Age

People18 - 120

Phase

I

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

MedImmune, LLC

Scientific Title

A Phase 1, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of MEDI5752 in Subjects With Advanced Solid Tumors

Eligibility

Inclusion

  1. Age ≥ 18 years at the time of screening
  2. World Health Organization/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment
  3. Life expectancy ≥ 12 weeks
  4. Histologically or cytologically-confirmed advanced solid tumors
  5. Subjects who have received prior anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapy or any concurrent chemotherapy, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment may be eligible to enter the study following a washout period as applicable
  6. Females of childbearing potential who are sexually active with a nonsterilized male partner must use at least one highly effective method of contraception
  7. Nonsterilized males who are sexually active with a female partner of childbearing potential must use a male condom with spermicide where locally available from Day 1 and for 90 days after the final dose of investigational product. Males receiving pemetrexed or carboplatin must use contraception during study treatment and up to 6 months thereafter.
  8. Subjects must have at least one measurable lesion
  9. Adequate organ and marrow function
  10. Written informed consent and any locally required authorization
  11. Subjects must provide tumor material as applicable

Exclusion

  1. Involvement in the planning and/or conduct of the study (applies to both MedImmune staff and/or staff at the study site)
  2. Concurrent enrollment in another clinical study, unless it is an observational clinical study or the follow-up period of an interventional study
  3. For subjects who have received prior anti-PD-1, anti-PD-L1, or anti-CTLA-4:

    1. Subjects must not have received anti-PD-1, anti-PD-L1, anti-CTLA-4 or any other immunotherapy or immune-oncology (IO) agent within 21 days of commencing treatment with investigational product.
    2. Subject must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy.
    3. All AEs while receiving prior immunotherapy must have completely resolved or resolved to Grade 1 prior to screening for this study.
  4. Current or prior use of immunosuppressive medication within 14 days before the first dose of investigational product is excluded.
  5. Receipt of live attenuated vaccine within 30 days prior to the first dose of investigational product.
  6. Active or prior documented autoimmune or inflammatory disorders
  7. History of active primary immunodeficiency:
  8. History of organ transplant
  9. Known allergy or reaction to any component of the planned study treatment.
  10. Untreated CNS metastatic disease, leptomeningeal disease, or cord compression
  11. Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v4.03 Grade 0 or 1, or to levels dictated in the inclusion/exclusion criteria
  12. Major surgical procedure (as defined by the investigator) within 28 days prior to the first dose of Investigational Product or still recovering from prior surgery
  13. Female subjects who are pregnant or breastfeeding, as well as male or female subjects of reproductive potential who are not willing to employ one highly effective method of birth control
  14. Uncontrolled intercurrent illness, that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the subject to give written informed consent.
  15. Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of the subject's safety or study results
  16. Judgment by the investigator that the subject is unsuitable to participate in the study and the subject is unlikely to comply with study procedures, restrictions, and requirements.

Inclusion

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

Exclusion

  • 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.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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