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Completed

NCT Number: NCT04440943

A Study of the PD-L1xCD27 Bispecific Antibody CDX-527 in Patients With Advanced Malignancies

This is an open-label, non-randomized, multicenter, dose-escalation and expansion study in patients with selected solid tumors.

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Key information

Conditions

Non-small Cell Lung Cancer Adenocarcinoma Adnexal Diseases Bladder Urothelial Carcinoma Breast Cancer Breast Diseases Breast Neoplasms Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Carcinoma, Renal Cell Cholangiocarcinoma Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Fallopian Tube Cancer Fallopian Tube Diseases Fallopian Tube Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Head and Neck Cancer Head and Neck Neoplasms Hepatic Cancer Kidney Diseases Kidney Neoplasms Liver Diseases Liver Neoplasms Lung Diseases Lung Neoplasms MSI-H Colorectal Cancer Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Other Solid Tumors Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Primary Peritoneal Carcinoma Renal Cell Carcinoma Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Stomach Diseases Stomach Neoplasms Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Northside Hospital, Atlanta, Georgia, United States

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About this study

This study will determine the safety, tolerability and activity of CDX-527.

Eligible patients that enroll to the dose-escalation portion of the study will be assigned to one of several dose levels of CDX-527. The dose-escalation part of the study will determine the safety profile of CDX-527 and determine which dose(s) of CDX-527 will be studied in the expansion part of the study.

The expansion part of the study will enroll eligible patients with certain solid tumors to be treated at dose(s) identified during dose-escalation

Up to 40 patients will be enrolled. All patients enrolled in the study will be closely monitored to determine if there is a response to the treatment as well as for any side effects that may occur.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Recurrent, locally advanced or metastatic solid tumor cancer excluding the following: MSI-low colorectal cancer, glioblastoma multiforme, prostate cancer, pancreatic cancer, mucosal and ocular melanoma.
  • Receipt of all standard therapies for the tumor type
  • Measurable (target) disease by iRECIST
  • If of childbearing potential (male or female), agrees to practice an effective form of contraception during study treatment and for at least 3 months following last treatment
  • Willingness to undergo a pre-treatment and on-treatment biopsy, if required

Key Exclusion Criteria:

  • History of severe hypersensitivity reactions to other monoclonal antibodies.
  • Previous treatment with any anti-CD27 antibody.
  • Inadequate washout period from prior therapy as defined in the Protocol.
  • Patients who have received more than 0 or 1 prior PD-1/PD-L1 inhibitor depending on their tumor type
  • Major surgery within 4 weeks prior to study treatment.
  • Use of immunosuppressive medications within 4 weeks or systemic corticosteroids within 2 weeks prior to study treatment.
  • Other prior malignancy, except for adequately treated basal or squamous cell skin cancer or in situ cancers. For all other cancers, the patient must be disease-free for at least 3 years to be allowed to enroll.
  • Thrombotic events within the last 6 months prior to study treatment
  • Active, untreated central nervous system metastases.
  • Active autoimmune disease or documented history of autoimmune disease.
  • History of (non-infectious) pneumonitis or has current pneumonitis.
  • Active diverticulitis
  • Known infection of HIV, Hepatitis B, or Hepatitis C.

There are additional criteria your study doctor will review with you to confirm your eligibility for the study.

Treatment and study plan

CDX-527

Drug

CDX-527 is administered by infusion every 2 weeks

Primary outcomes

  1. Safety and Tolerability of CDX-527 as assessed by CTCAE v5.0

    Time frame: From first dose through 28 days after last dose

    The rates of drug-related adverse events will be summarized and maximum tolerated dose will be determined.

Secondary outcomes

  1. Objective Response Rate

    Time frame: Every 8 weeks starting with first dose until disease progression, assessed up to approximately 1-2 years.

    The percentage of patients who achieve a confirmed immune complete response (iCR) or immune partial response (iPR)

  2. Clinical Benefit Rate

    Time frame: Every 8 weeks, starting with first dose until disease progression, assessed up to approximately 1-2 years.

    The percentage of patients who achieve best response of confirmed iCR or iPR, or immune stable disease (iSD) for at least four months

  3. Duration of Response

    Time frame: First occurrence of a documented objective response to disease progression or death (up to approximately 1-2 years)

    The interval from which measurement criteria are first met for iCR or iPR until the first date that progressive disease is objectively documented

  4. Progression-free Survival

    Time frame: From the first dose to the first occurrence of disease progression or death due to any cause (up to approximately 1-2 years)

    The time from start of study drug to time of progression or death, whichever occurs first

  5. Overall Survival

    Time frame: The time from start of study drug to death from any cause (up to approximately 1-2 years)

    The time from start of study drug to death

  6. Immunogenicity Evaluation

    Time frame: Prior to the first dose of study treatment, then intermittently before dosing, and up to 60 days after the last dose

    Serum samples will be obtained for assessment of human anti-CDX-527 antibodies

  7. Pharmacokinetic Evaluation

    Time frame: Before and after dosing, with additional timepoints after the first two doses, then intermittently before dosing and up to 60 days after the last dose

    CDX-527 serum concentrations will be measured at specified visits.

Sponsors and collaborators

Lead sponsor

Celldex Therapeutics

Industry

Registry information

Official study title

A Phase 1 Study of the PD-L1xCD27 Bispecific Antibody CDX-527 in Patients With Advanced Malignancies

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jun 22, 2020
Registry last updated
Jun 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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