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.

  • STATUS
    Recruiting
  • End date
    Mar 20, 2024
  • participants needed
    366
  • sponsor
    MedImmune LLC
Updated on 21 October 2022
paclitaxel
cancer
measurable disease
progressive disease
pemetrexed
carboplatin
hormone therapy
pembrolizumab
programmed cell death 1 ligand 1
cancer treatment
solid tumors
cancer chemotherapy

Summary

The purpose of this study is to evaluate MEDI5752 and carboplatin and pemetrexed or paclitaxel or nab-paclitaxel in adult subjects with advanced solid tumors, when administered as a single agent or combined with chemotherapy.

Description

This is a phase 1, first-time-in-human, multicenter, open-label, dose-escalation and dose-expansion study to evaluate the safety and tolerability, and efficacy, pharmacokinetics and Immunogenicity of MEDI5752 and carboplatin and pemetrexed or paclitaxel or nab-paclitaxel in adult subjects with advanced solid tumors, when administered as a single agent or combined with chemotherapy.

Details
Condition Selected Advanced Solid Tumors
Treatment carboplatin, Pembrolizumab, Pemetrexed, durvalumab, MEDI5752, Durvalumab [only applicable to some countries], Paclitaxel or Nab-Paclitaxel
Clinical Study IdentifierNCT03530397
SponsorMedImmune LLC
Last Modified on21 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age ≥ 18 years at the time of screening
World Health Organization/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment
Life expectancy ≥ 12 weeks
Histologically or cytologically-confirmed advanced solid tumors
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
Females of childbearing potential who are sexually active with a nonsterilized male partner must use at least one highly effective method of contraception
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
Subjects must have at least one measurable lesion
Adequate organ and marrow function
Written informed consent and any locally required authorization
Subjects must provide tumor material as applicable

Exclusion Criteria

Involvement in the planning and/or conduct of the study (applies to both MedImmune staff and/or staff at the study site)
Concurrent enrollment in another clinical study, unless it is an observational clinical study or the follow-up period of an interventional study
For subjects who have received prior anti-PD-1, anti-PD-L1, or anti-CTLA-4
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
Subject must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy
All AEs while receiving prior immunotherapy must have completely resolved or resolved to Grade 1 prior to screening for this study
Current or prior use of immunosuppressive medication within 14 days before the first
Receipt of live attenuated vaccine within 30 days prior to the first dose of investigational product
dose of investigational product is excluded
Active or prior documented autoimmune or inflammatory disorders
History of active primary immunodeficiency
History of organ transplant
Known allergy or reaction to any component of the planned study treatment
Untreated CNS metastatic disease, leptomeningeal disease, or cord compression
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
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
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
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
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
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