Description:
This is an open-label, non-randomized, multicenter, dose-escalation and expansion study in
patients with selected solid tumors.
Title
- Brief Title: A Study of the PD-L1xCD27 Bispecific Antibody CDX-527 in Patients With Advanced Malignancies
- Official Title: A Phase 1 Study of the PD-L1xCD27 Bispecific Antibody CDX-527 in Patients With Advanced Malignancies
Clinical Trial IDs
- ORG STUDY ID:
CDX527-01
- NCT ID:
NCT04440943
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
Interventions
Drug | Synonyms | Arms |
---|
CDX-527 | | CDX-527 |
Purpose
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 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.
Trial Arms
Name | Type | Description | Interventions |
---|
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. | |
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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Safety and Tolerability of CDX-527 as assessed by CTCAE v5.0 |
Time Frame: | From first dose through 28 days after last dose |
Safety Issue: | |
Description: | The rates of drug-related adverse events will be summarized and maximum tolerated dose will be determined. |
Secondary Outcome Measures
Measure: | Objective Response Rate |
Time Frame: | Every 8 weeks starting with first dose until disease progression, assessed up to approximately 1-2 years. |
Safety Issue: | |
Description: | The percentage of patients who achieve a confirmed immune complete response (iCR) or immune partial response (iPR) |
Measure: | Clinical Benefit Rate |
Time Frame: | Every 8 weeks, starting with first dose until disease progression, assessed up to approximately 1-2 years. |
Safety Issue: | |
Description: | The percentage of patients who achieve best response of confirmed iCR or iPR, or immune stable disease (iSD) for at least four months |
Measure: | Duration of Response |
Time Frame: | First occurrence of a documented objective response to disease progression or death (up to approximately 1-2 years) |
Safety Issue: | |
Description: | The interval from which measurement criteria are first met for iCR or iPR until the first date that progressive disease is objectively documented |
Measure: | 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) |
Safety Issue: | |
Description: | The time from start of study drug to time of progression or death, whichever occurs first |
Measure: | Overall Survival |
Time Frame: | The time from start of study drug to death from any cause (up to approximately 1-2 years) |
Safety Issue: | |
Description: | The time from start of study drug to death |
Measure: | 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 |
Safety Issue: | |
Description: | Serum samples will be obtained for assessment of human anti-CDX-527 antibodies |
Measure: | 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 |
Safety Issue: | |
Description: | CDX-527 serum concentrations will be measured at specified visits. |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Celldex Therapeutics |
Last Updated
February 11, 2021