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

NCT04440943 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: CDX527-01
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Non-small Cell Lung Cancer; Breast Cancer; Gastric Cancer; Renal Cell Carcinoma; Ovarian Cancer; Primary Peritoneal Carcinoma; Fallopian Tube Cancer; Cholangiocarcinoma; Bladder Urothelial Carcinoma; MSI-H Colorectal Cancer; Esophageal Cancer; Hepatic Cancer; Head and Neck Cancer; Other Solid Tumors

Outcome Measures

Primary Outcomes (1)

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

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

  From first dose through 28 days after last dose

Secondary Outcomes (7)

• Objective Response Rate

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

• Clinical Benefit Rate

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

• Duration of Response

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

• Progression-free Survival

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

• Overall Survival

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

Study Arms (1)

CDX-527

EXPERIMENTAL

Dose-escalation phase: Eligible patients will receive CDX-527 treatment based on cohort assigned until progression or intolerance. Expansion phase: Patients will receive CDX-527 at the dose level(s) chosen during the escalation phase.

Drug: CDX-527

Interventions

CDX-527 DRUG

CDX-527 is administered by infusion every 2 weeks

CDX-527

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Celldex Therapeutics: lead

Study Sites (5)

Northside Hospital

Atlanta, Georgia, 30342, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Oncology Hematology West, PC dba Nebraska Cancer Specialists

Omaha, Nebraska, 68130, United States

Location

Duke Cancer Center

Durham, North Carolina, 27710, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Breast Neoplasms; Stomach Neoplasms; Carcinoma, Renal Cell; Ovarian Neoplasms; Fallopian Tube Neoplasms; Cholangiocarcinoma; Esophageal Neoplasms; Liver Neoplasms; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases; Esophageal Diseases; Liver Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2020
• First Posted: June 22, 2020
• Study Start: August 4, 2020
• Primary Completion: April 6, 2023
• Study Completion: April 6, 2023
• Last Updated: June 18, 2023

Record last verified: 2023-06

Locations

US (5)