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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 maximum tolerated dose of CDX-585 while also evaluating the safety, tolerability, and efficacy of CDX-585 in patients with cancer.
Eligible patients that enroll to the dose-escalation portion of the study will be assigned to one of several dose levels of CDX-585. The dose-escalation part of the study will test the safety profile of CDX-585 and determine which dose of CDX-585 will be studied in the expansion portions of the study.
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.
The expansion portion of the study will further evaluate the safety of CDX-585 in selected tumor types at the dose level chosen during the escalation part of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CDX-585 | Experimental | Dose-escalation phase: Eligible patients will receive treatment, based on cohort assigned, in 2-week cycles until progression or intolerance. Expansion phase: Patients enrolled in the expansion phase of the study will receive CDX-585 at the dose level chosen during the escalation phase. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CDX-585 | Drug | CDX-585 is administered by infusion every 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose escalation: To determine the maximum tolerated dose of CDX-585 and to select the CDX-585 dose(s) for evaluation in tumor-specific expansion cohorts | The rates of drug-related adverse events will be summarized, and maximum tolerated dose will be determined. | Approximately 12 months |
| Tumor-specific expansion cohorts: To further evaluate the safety of CDX-585 by tumor type. | The rates of drug-related adverse events will be summarized, and further evaluated in specific tumor types. | Approximately 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability of CDX-585 as assessed by CTCAE v5.0 | The rates of drug-related adverse events will be summarized and evaluated. | From first dose through 90 days after last dose |
| Objective Response Rate |
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Key Inclusion Criteria:
Key Exclusion Criteria:
There are additional criteria your study doctor will review with you to confirm eligibility.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| George Washington University Cancer Center | Washington D.C. | District of Columbia | 20037 | United States | ||
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The percentage of patients who achieve a confirmed immune complete response (iCR) or immune partial response (iPR)
| Assessed up to approximately 1-3 years. |
| Clinical Benefit Rate | The percentage of patients who achieve best response of confirmed iCR or iPR, or immune stable disease (iSD) for at least four months | Assessed up to approximately 1-3 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 1-3 years) |
| Progression-free Survival | The time from start of study drug to time of progression or death, whichever occurs first | Cycle 1, day 1 to the first occurrence of disease progression or death due to any cause (up to approximately 1-3 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 1-3 years) |
| Pharmacokinetic Evaluation | CDX-585 serum concentrations will be measured at specified visits | Prior to, during, and at multiple time points after doses 1-4. Prior to every other dose from fifth dose, and at 30 and 90 days post last dose of study treatment |
| Immunogenicity Evaluation | Samples will be obtained for assessment of human anti-CDX-585 | Prior to the first three doses and every other dose from the fifth dose of study treatment, then 30 and 90 days after the last dose |
| AdventHealth Celebration |
| Celebration |
| Florida |
| 34747 |
| United States |
| Perlmutter Cancer Center at NYU Langone Health | New York | New York | 10016 | United States |
| Providence Cancer Institute | Portland | Oregon | 97213 | United States |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D013274 | Stomach Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| D015179 | Colorectal Neoplasms |
| D004938 | Esophageal Neoplasms |
| D008113 | Liver Neoplasms |
| D002292 | Carcinoma, Renal Cell |
| D018281 | Cholangiocarcinoma |
| D010190 | Pancreatic 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 |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |
| D007414 | Intestinal Neoplasms |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D004935 | Esophageal Diseases |
| D008107 | Liver Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D010182 | Pancreatic Diseases |
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