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This is an open-label, non-randomized, multicenter, dose-escalation and expansion study in patients with selected solid tumors.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CDX-527 | Drug | CDX-527 is administered by infusion every 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | The percentage of patients who achieve a confirmed immune complete response (iCR) or immune partial response (iPR) | Every 8 weeks starting with first dose until disease progression, assessed up to approximately 1-2 years. |
| Clinical Benefit Rate |
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Key Inclusion Criteria:
Key Exclusion Criteria:
There are additional criteria your study doctor will review with you to confirm your eligibility for the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northside Hospital | Atlanta | Georgia | 30342 | United States | ||
| University of Chicago |
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The percentage of patients who achieve best response of confirmed iCR or iPR, or immune stable disease (iSD) for at least four months |
| Every 8 weeks, starting with first dose until disease progression, assessed up to approximately 1-2 years. |
| Duration of Response | The interval from which measurement criteria are first met for iCR or iPR until the first date that progressive disease is objectively documented | First occurrence of a documented objective response to disease progression or death (up to approximately 1-2 years) |
| Progression-free Survival | The time from start of study drug to time of progression or death, whichever occurs first | 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 | The time from start of study drug to death from any cause (up to approximately 1-2 years) |
| Immunogenicity Evaluation | Serum samples will be obtained for assessment of human anti-CDX-527 antibodies | Prior to the first dose of study treatment, then intermittently before dosing, and up to 60 days after the last dose |
| Pharmacokinetic Evaluation | CDX-527 serum concentrations will be measured at specified visits. | 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 |
| Chicago |
| Illinois |
| 60637 |
| United States |
| Oncology Hematology West, PC dba Nebraska Cancer Specialists | Omaha | Nebraska | 68130 | United States |
| Duke Cancer Center | Durham | North Carolina | 27710 | United States |
| Providence Portland Medical Center | Portland | Oregon | 97213 | United States |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D001943 | Breast Neoplasms |
| D013274 | Stomach Neoplasms |
| D002292 | Carcinoma, Renal Cell |
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| D018281 | Cholangiocarcinoma |
| D004938 | Esophageal Neoplasms |
| D008113 | Liver Neoplasms |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D005833 | Genital Neoplasms, Female |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |
| D004935 | Esophageal Diseases |
| D008107 | Liver Diseases |
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