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BRIEF TITLE: Study of the PD-L1xCD27 Bispecific Antibody CDX-527 in Patients With Advanced Malignancies

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


  • Org Study ID: CDX527-01
  • Secondary ID:
  • NCT ID: NCT04440943
  • NCT Alias:
  • Sponsor: Celldex Therapeutics - Industry
  • Source: Celldex Therapeutics

Brief Summary

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

Detailed Description


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 96 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.

Overal Status Start Date Phase Study Type
Recruiting July 2020 Phase 1 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Safety and Tolerability of CDX-527 as assessed by CTCAE v5.0

Primary Outcome 1 - Time Frame: From first dose through 28 days after last dose

Condition:

  • 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

Eligibility

Criteria:
Key Inclusion Criteria:

1. 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.

2. Receipt of all standard therapies for the tumor type

3. Measurable (target) disease by iRECIST

4. 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

5. Willingness to undergo a pre-treatment and on-treatment biopsy, if required

Key Exclusion Criteria:

1. History of severe hypersensitivity reactions to other monoclonal antibodies.

2. Previous treatment with any anti-CD27 antibody.

3. Inadequate washout period from prior therapy as defined in the Protocol.

4. Patients who have received more than 0 or 1 prior PD-1/PD-L1 inhibitor depending on
their tumor type

5. Major surgery within 4 weeks prior to study treatment.

6. Use of immunosuppressive medications within 4 weeks or systemic corticosteroids within
2 weeks prior to study treatment.

7. 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.

8. Thrombotic events within the last 6 months prior to study treatment

9. Active, untreated central nervous system metastases.

10. Active autoimmune disease or documented history of autoimmune disease.

11. History of (non-infectious) pneumonitis or has current pneumonitis.

12. Active diverticulitis

13. 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.
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Contact

Name: Celldex Therapeutics

Phone: (844) 723-9363

Email: info@celldex.com

Location

Facility Status Contact
Northside Hospital
Atlanta, Georgia 30342
United States
Recruiting Anila Lokhandwala
404-236-8124