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Clinical trials
catalyst calendar across sponsors →Studies where CLDX is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
43 interventional · 2 expanded access · 3 with posted results
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| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| Long-term Efficacy and Safety Extension (LTE) Study of Barzolvolimab in Participants With Chronic Spontaneous UrticariaNCT07256392Time to disease worsening or treatment failure through Week 52 based on the occurrence of UAS7 (Urticaria Activity Score) of 16 or greater.Non-randomized · Open-label · Treatment | Phase 3 | Enrolling by invitation | Biological: barzolvolimab · Other: Standard of Care | Chronic Spontaneous Urticaria | 1,370 | Sep 2028 | ≤ 773 d | 2026-07-29 |
| A Study to Investigate Efficacy, Safety and Tolerability of Barzolvolimab Versus Placebo in Adults With Cold Induced Urticaria and Symptomatic Dermographism Inadequately Controlled by H1-antihistamines (EMBARQ - ColdU and SD)NCT07266402Complete response to provocation testing at Week 12Randomized · Quadruple-masked · Treatment | Phase 3 | Recruiting | Drug: Barzolvolimab, Matching Placebo | Chronic Inducible Urticaria, Cold Urticaria, Cold-Induced Urticaria, Symptomatic Dermographism | 240 | Jun 2028 | ≤ 681 d | 2026-07-29 |
| A Study of CDX-622 in Participants With Mild to Moderate AsthmaNCT07330778To evaluate the safety and tolerability profile of CDX-622 in adults with mild to moderate asthma.Open-label · Treatment | Phase 1 | Recruiting | Drug: CDX-622 | Mild to Moderate Asthma | 12 | Mar 2027 | ≤ 224 d | 2026-07-02 |
| A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous UrticariaNCT06445023Mean change from baseline to Week 12 of UAS7 (Urticaria Activity Score)Randomized · Quadruple-masked · Treatment | Phase 3 | Active, not recruiting | Biological: barzolvolimab, Matching placebo | Chronic Spontaneous Urticaria | 963 | Oct 2026 | ≤ 73 d | 2026-03-25 |
| A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria (CSU)NCT06455202Mean change from baseline to Week 12 of UAS7 (Urticaria Activity Score)Randomized · Quadruple-masked · Treatment | Phase 3 | Active, not recruiting | Biological: barzolvolimab, Matching placebo | Chronic Spontaneous Urticaria | 976 | Oct 2026 | ≤ 73 d | 2026-03-25 |
| A Study of Barzolvolimab in Patients With Atopic DermatitisNCT06727552Percent change from Baseline in the weekly average of the daily Peak Pruritus Numerical Rating Scale (PP-NRS) score at Week 16Randomized · Quadruple-masked · Treatment | Phase 2 | Active, not recruiting | Biological: Barzolvolimab · Drug: Matching placebo | Atopic Dermatitis | 131 | 2026-05-06actual | — | 2026-08-11 |
| A Study of Barzolvolimab in Patients With Prurigo NodularisNCT06366750Proportion of participants with improvement in Worst Itch Numeric Rating Scale (WI-NRS) by ≥ 4 from baseline to Week 12.Randomized · Quadruple-masked · Treatment | Phase 2 | Active, not recruiting | Biological: barzolvolimab · Other: Matching Placebo | Prurigo Nodularis | 140 | 2026-03-17actual | — | 2026-08-04 |
| A Phase I Study of CDX-622NCT06650761Safety as assessed by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Trials. Infusion reactions will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0.Randomized · Double-masked · Treatment | Phase 1 | Completed | Drug: CDX-622, Normal Saline | Healthy Participants | 85 | 2026-04-24actual | — | 2026-05-04 |
| A Study of CDX-0159 in Patients With Eosinophilic EsophagitisNCT05774184Absolute change from baseline to Week 12 in peak intraepithelial mast cell (PMC) count (PMC/hpf).Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Biological: barzolvolimab · Drug: Matching Placebo | Eosinophilic Esophagitis | 86 | 2025-06-04actual | — | 2026-05-27 |
| A Study of CDX-585 in Patients With Advanced MalignanciesNCT05788484Dose escalation: To determine the maximum tolerated dose of CDX-585 and to select the CDX-585 dose(s) for evaluation in tumor-specific expansion cohortsOpen-label · Treatment | Phase 1 | Completed | Drug: CDX-585 | Non-small Cell Lung Cancer, Gastric Cancer, Head and Neck Cancer, Ovarian Cancer, Primary Peritoneal Carcinoma, Fallopian Tube Cancer, Bladder Urothelial Carcinoma, Colorectal Cancer, Esophageal Cancer, Hepatic Cancer, Renal Cell Carcinoma, Cholangiocarcinoma, Pancreatic Cancer, Other Solid Tumors | 20 | 2025-05-21actual | — | 2025-06-15 |
| A Study of CDX-0159 in Patients With Chronic Inducible UrticariaNCT05405660Percentage of patients with a negative provocation test at week 12Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Biological: barzolvolimab · Drug: Matching Placebo | Chronic Inducible Urticaria | 196 | 2024-06-12actual | — | 2025-11-06 |
| A Phase 2 Study of CDX-0159 in Patients With Chronic Spontaneous UrticariaNCT05368285Mean change from baseline to Week 12 of UAS7 (Urticaria Activity Score)Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Biological: barzolvolimab · Drug: Matching Placebo | Chronic Spontaneous Urticaria | 208 | 2023-09-28actual | — | 2025-03-26 |
| A Study of CDX-0159 in Patients With Prurigo NodularisNCT04944862Safety and tolerability as assessed by the incidence and severity of adverse eventsRandomized · Double-masked · Treatment | Phase 1 | Completed | Biological: CDX-0159 · Drug: Normal saline | Prurigo Nodularis | 24 | 2023-07-31actual | — | 2023-08-14 |
| A Study of the PD-L1xCD27 Bispecific Antibody CDX-527 in Patients With Advanced MalignanciesNCT04440943Safety and Tolerability of CDX-527 as assessed by CTCAE v5.0Open-label · Treatment | Phase 1 | Completed | Drug: CDX-527 | 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 | 27 | 2023-04-06actual | — | 2023-06-18 |
| A Study of CDX-0159 in Patients With Chronic Spontaneous UrticariaNCT04538794Safety as assessed by the incidence and severity of adverse eventsRandomized · Double-masked · Treatment | Phase 1 | Completed | Drug: CDX-0159, Normal Saline | Chronic Spontaneous Urticaria | 45 | 2023-01-17actual | — | 2023-07-19 |
| A Single Dose Study of the Safety, Pharmacokinetics and Pharmacodynamics of CDX-0159 in Patients With Cold Contact Urticaria, Symptomatic Dermographism, or Cholinergic UrticariaNCT04548869Safety as assessed by the incidence and severity of adverse eventsOpen-label · Treatment | Phase 1 | Completed | Drug: CDX-0159 | Cold Urticaria, Cold Contact Urticaria, Symptomatic Dermographism, Symptomatic Dermatographism, Cholinergic Urticaria | 41 | 2022-12-16actual | — | 2023-05-17 |
| A Study of CDX-1140 (CD40) as Monotherapy or in Combination in Patients With Advanced MalignanciesNCT03329950Safety and Tolerability of CDX-1140 as assessed by CTCAE v5.0Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: CDX-1140, CDX-301, pembrolizumab, Chemotherapy | Melanoma, Non-small Cell Lung Cancer, Breast Cancer, Gastric Cancer, Renal Cell Carcinoma, Ovarian Cancer, Cholangiocarcinoma, Bladder Urothelial Carcinoma, Pancreatic Adenocarcinoma, Colorectal Cancer, Esophageal Cancer, Hepatic Cancer, Head and Neck Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer, Other Solid Tumors, Diffuse Large B-cell Lymphoma (DLBCL), Mantle Cell Lymphoma, Indolent B-cell Lymphomas, Non-Hodgkin Lymphoma, Follicular Lymphoma, Lymphoplasmacytic Lymphoma, Waldenstrom's Disease, Marginal Zone Lymphoma, Mucosa Associated Lymphoid Tissue, Small Lymphocytic Leukemia | 132 | 2022-09-13actual | — | 2024-03-28 |
| A Phase 1 Study of Subcutaneous CDX-0159 in Healthy SubjectsNCT05031624Safety as assessed by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine TrialsRandomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: CDX-0159, Normal saline | Healthy Subjects | 32 | 2022-01-14actual | — | 2022-01-21 |
| A Study of CDX-3379 and Cetuximab and in Patients With Advanced Head and Neck Squamous Cell CarcinomaNCT03254927results2023-04-03Objective Response RateOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: Sponsor decision based on emerging risk-benefit profile | Drug: CDX-3379 and cetuximab | Advanced Head and Neck Squamous Cell Carcinoma | 30 | 2020-09-16actual | — | 2023-04-03 |
| A Phase 1 Study of CDX-0159NCT04146129Safety as assessed by CTCAE v5.0Randomized · Double-masked · Treatment | Phase 1 | Completed | Drug: CDX-0159, Normal saline | Healthy Subjects | 32 | 2020-04-06actual | — | 2020-07-07 |
| A Dose Escalation and Cohort Expansion Study of Anti-CD27 (Varlilumab) and Anti-PD-1 (Nivolumab) in Advanced Refractory Solid TumorsNCT02335918Phase I: Number of participants with treatment-related adverse events as determined by CTCAE v4.0, dose-limiting toxicities, and laboratory abnormalities.Open-label · Treatment | Phase 1/2 | Completed | Drug: Combination of varlilumab and nivolumab | Squamous Cell Carcinoma of the Head and Neck (SCCHN), Ovarian Carcinoma-Enrollment Completed, Colorectal Cancer (CRC)-Enrollment Completed, Renal Cell Carcinoma (RCC) (Phase ll Only), Glioblastoma (GBM) (Phase ll Only)-Enrollment Completed | 175 | 2018-12-12actual | — | 2019-12-09 |
| A Dose Escalation, Safety and Activity Study of CDX-014 in Patients With Renal Cell Carcinoma and Ovarian Clear Cell CarcinomaNCT02837991Dose Escalation - Determine Maximum Tolerated Dose (MTD)Open-label · Treatment | Phase 1 | Terminatedsponsor's stated reason: Development of CDX-014 discontinued | Drug: CDX-014 | Renal Cell Carcinoma (RCC), Clear-cell Renal Cell Carcinoma, Papillary Renal Cell Carcinoma, Kidney Neoplasms, Metastatic Renal Cell Carcinoma, Ovarian Clear Cell Carcinoma | 16 | 2018-11-16actual | — | 2020-06-04 |
| A Study of Glembatumumab Vedotin as Monotherapy or in Combination With Immunotherapies in Patients With Advanced MelanomaNCT02302339results2019-09-06Objective Response Rate (ORR)Non-randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: Development of glembatumumab vedotin was discontinued | Drug: glembatumumab vedotin, glembatumumab vedotin and varlilumab, glembatumumab vedotin and PD-1 targeted checkpoint inhibitor (nivolumab OR pembrolizumab), glembatumumab vedotin and CDX-301 | Melanoma | 132 | 2018-06-14actual | — | 2019-09-06 |
| A Study to Evaluate the Safety and Pharmacokinetics of CDX-0158 in Adult Patients With Advanced Solid TumorsNCT02642016Dose limiting toxicities for CDX-0158Open-label · Treatment | Phase 1 | Completed | Biological: CDX-0158 (formerly known as KTN-0158) | Advanced Cancer | 28 | 2018-01-30actual | — | 2019-06-12 |
| Study of Glembatumumab Vedotin (CDX-011) in Patients With Metastatic, gpNMB Over-Expressing, Triple Negative Breast CancerNCT01997333results2019-03-08Progression Free Survival (PFS)Randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: CDX-011, Capecitabine | Metastatic gpNMB Over-expressing Triple Negative Breast Cancer | 327 | 2017-11-30actual | — | 2019-03-08 |
| A Study of Varlilumab (Anti-CD27) and Sunitinib in Patients With Metastatic Clear Cell Renal Cell CarcinomaNCT02386111Phase 1: Safety and tolerability of varlilumab and varlilumab in combination with sunitinib as measured by incidence of drug related adverse events (AEs), serious drug related AEs, dose-limiting toxicities and laboratory test abnormalities.Open-label · Treatment | Phase 1 | Terminatedsponsor's stated reason: Portfolio re-prioritization | Drug: Combination of varlilumab and sunitinib | Carcinoma, Renal Cell, Kidney Diseases, Kidney Neoplasms, Urogenital Neoplasms, Urologic Diseases, Urologic Neoplasms, Neoplasms, Neoplasms by Histologic Type, Clear-cell Metastatic Renal Cell Carcinoma | 17 | Aug 2017actual | — | 2018-07-26 |
| A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of KTN3379 in Adult Subjects With Advanced TumorsNCT02014909Dose limiting toxicities for KTN3379 alone or in combinationNon-randomized · Open-label · Treatment | Phase 1 | Completed | Biological: KTN3379 | Advanced Cancer | 64 | 2017-05-25actual | — | 2017-07-24 |
| A Study of Varlilumab and Atezolizumab in Patients With Advanced CancerNCT02543645Phase l: Safety and tolerability of varlilumab in combination with atezolizumab as measured by incidence of drug related adverse events (AEs), serious drug related AEs, dose-limiting toxicities and laboratory test abnormalities.Open-label · Treatment | Phase 1 | Terminatedsponsor's stated reason: Portfolio re-prioritization | Drug: Combination of Varlilumab and Atezolizumab | Carcinoma, Renal Cell, Kidney Diseases, Kidney Neoplasms, Urogenital Neoplasms, Urologic Diseases, Urologic Neoplasms, Neoplasms by Histologic Type, Neoplasms, Clear-cell Metastatic Renal Cell Carcinoma, Melanoma, Triple Negative Breast Cancer, Bladder Cancer, Head and Neck Cancer, Non-small Cell Lung Cancer | 18 | Apr 2017actual | — | 2018-04-30 |
| Phase III Study of Rindopepimut/GM-CSF in Patients With Newly Diagnosed GlioblastomaNCT01480479Overall SurvivalRandomized · Triple-masked · Treatment | Phase 3 | Completed | Drug: Rindopepimut (CDX-110) with GM-CSF, Temozolomide, KLH | Glioblastoma, Small Cell Glioblastoma, Giant Cell Glioblastoma, Gliosarcoma, Glioblastoma With Oligodendroglial Component | 745 | Nov 2016actual | — | 2018-01-16 |
| A Study of Varlilumab (Anti-CD27) and Ipilimumab and CDX-1401 in Patients With Unresectable Stage III or IV MelanomaNCT02413827Phase l: Safety and tolerability of varlilumab in combination with ipilimumab as measured by incidences of drug related adverse events (AEs), serious drug related AEs, dose-limiting toxicities and laboratory test abnormalities.Non-randomized · Open-label · Treatment | Phase 1/2 | Terminatedsponsor's stated reason: Feasibility concerns due to changes in standard of care | Drug: Combination of varlilumab and ipilimumab, Cohort A: varlilumab & ipilimumab; Cohort B: varlilumab, ipilimumab, CDX-1401 & poly-ICLC | Unresectable Stage III or Stage IV Melanoma | 9 | 2016-11-02actual | — | 2017-04-07 |
| Enhancing Radioiodine Incorporation Into BRAF Mutant Thyroid Cancers With the Combination of Vemurafenib and KTN3379NCT02456701The number of patients with BRAF MUT, radioiodine-refractory thyroid cancer in which the combination of vemurafenib and KTN3379 can increase tumoral iodine incorporation to warrant 131I treatmentOpen-label · Treatment | Phase 1 | Completed | Biological: KTN3379 · Drug: vemurafenib | Thyroid Cancer | 7 | 2016-10-13actual | — | 2017-09-05 |
| A Window of Opportunity Study of KTN3379 in Surgically Resectable Head and Neck Cancer PatientsNCT02473731Change in pErbB3 levels in tumor tissueRandomized · Open-label · Treatment | Phase 1 | Completed | Biological: KTN3379 | Squamous Cell Carcinoma of the Head and Neck | 12 | 2016-09-22actual | — | 2019-08-01 |
| A Safety and Tolerability Study of CDX-301 With or Without Plerixafor for Stem Cell Mobilization in Matched Related Allogeneic Donor/Recipient Sibling Transplant PairsNCT02200380Safety and tolerability profile of CDX-301 with or without plerixafor in healthy adult sibling stem cell donors.Non-randomized · Open-label · Treatment | Phase 2 | Terminated | Drug: CDX-301, CDX-301 and plerixafor | For Donors, Related Donors Giving Peripheral Blood Stem Cells (PBSC) to a Sibling, For Recipients, Acute Myelogenous Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Myelodysplastic Syndrome (MDS), Chronic Myelogenous Leukemia (CML), Non-Hodgkins Lymphoma (NHL), Hodgkins Disease (HD), Chronic Lymphocytic Leukemia (CLL) | 36 | Mar 2016actual | — | 2017-04-07 |
| A Study of CDX-1127 (Varlilumab) in Patients With Select Solid Tumor Types or Hematologic CancersNCT01460134Characterize the adverse events associated with CDX-1127 administrationNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: CDX-1127, CDX-1127, CDX-1127 | CD27 Expressing B-cell Malignancies for Example Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, Mantle Cell Lymphoma, Marginal Zone B Cell Lymphoma), Any T-cell Malignancy, Solid Tumors (Metastatic Melanoma, Renal (Clear) Cell Carcinoma, Hormone-refractory Prostate Adenocarcinoma, Ovarian Cancer, Colorectal Adenocarcinoma, Non-small Cell Lung Cancer), Burkett's Lymphoma, Primary Lymphoma of the Central Nervous System | 90 | Dec 2015actual | — | 2018-01-31 |
| A Study of Rindopepimut/GM-CSF in Patients With Relapsed EGFRvIII-Positive GlioblastomaNCT01498328Groups 1 and 2: Progression-free survival rateRandomized · Triple-masked · Treatment | Phase 2 | Completed | Drug: Bevacizumab, Rindopepimut (CDX-110) with GM-CSF, KLH | Glioblastoma, Small Cell Glioblastoma, Giant Cell Glioblastoma, Gliosarcoma, Glioblastoma With Oligodendroglial Component, Recurrent Glioblastoma, Relapsed Glioblastoma | 127 | Apr 2015actual | — | 2020-02-17 |
| Clinical Trial of CDX-1135 in Pediatric and Adult Patients With Dense Deposit DiseaseNCT01791686SafetyOpen-label · Treatment | Phase 1 | Terminatedsponsor's stated reason: Portfolio prioritization due to slow enrollment and variable spectrum of potential complement abnormalities in DDD patients. | Drug: CDX-1135 | Dense Deposit Disease, Membranoproliferative Glomerulonephritis Type II, C3 Glomerulonephritis | 1 | Mar 2014actual | — | 2014-03-07 |
| A Study to Evaluate CDX-301 (rhuFlt3L) in Healthy VolunteersNCT01465139Number of reported adverse eventsNon-randomized · Open-label · Other | Phase 1 | Completed | Drug: CDX-301 | Healthy | 30 | Nov 2012actual | — | 2017-06-27 |
| A Study of CDX-011 (CR011-vcMMAE) in Patients With Advanced GPNMB-expressing Breast CancerNCT01156753Objective response rateRandomized · Open-label · Treatment | Phase 2 | Completed | Drug: CDX-011, "Investigator's Choice" chemotherapy | Breast Cancer | 120 | Oct 2012actual | — | 2017-07-02 |
| A Study of CDX-1401 in Patients With Malignancies Known to Express NY-ESO-1NCT00948961Occurrence of adverse events (side effects)Open-label · Treatment | Phase 1/2 | Completed | Biological: CDX-1401 in combination with Resiquimod and/or Poly-ICLC, CDX-1401, Resiquimod, poly-ICLC | Advanced Malignancies | 70 | Jun 2012actual | — | 2016-06-27 |
| A Study of the CDX-1307 Vaccine Regimen in Patients With Newly Diagnosed Muscle-Invasive Bladder Cancer (The "N-ABLE" Study)NCT010944962 year Recurrence-Free Survival RateOpen-label · Treatment | Phase 2 | Terminatedsponsor's stated reason: Portfolio prioritization due to slow enrollment | Biological: CDX-1307 Vaccine Regimen · Drug: Chemotherapy | Bladder Cancer | 3 | Jul 2011actual | — | 2020-02-13 |
| Phase II Study of Rindopepimut (CDX-110) in Patients With Glioblastoma MultiformeNCT00458601Progression-free survival statusOpen-label · Treatment | Phase 2 | Completed | Drug: CDX-110 with GM-CSF, Temozolomide | Malignant Glioma | 82 | Nov 2010actual | — | 2018-01-16 |
| A Study of CDX-1307, in Patients With Incurable Breast, Colorectal, Pancreatic, Ovarian or Bladder Cancer (CDX 1307-01)NCT00709462To establish the safety and tolerability profile of CDX-1307 in patients with incurable breast, colorectal, pancreatic, ovarian or bladder cancer, alone and in combination with adjuvants.Non-randomized · Open-label · Treatment | Phase 1 | Completed | Biological: CDX1307 | Breast Cancer, Colorectal Cancer, Pancreatic Cancer, Bladder Cancer, Ovarian Cancer | 48 | May 2010actual | — | 2010-07-26 |
| Phase I Study of CDX-1307, hCG-B Vaccine, for Patients With Incurable, Locally Advanced or Metastatic Breast, Colorectal, Pancreatic, Bladder or Ovarian CancerNCT00648102To establish safety and tolerability profile of CDX1307 alone and with adjuvant in patients with breast, colorectal, pancreatic, bladder and ovarian cancerNon-randomized · Open-label · Treatment | Phase 1 | Completed | Biological: CDX-1307 | Breast Cancer, Colorectal Cancer, Pancreatic Cancer, Bladder Cancer, Ovarian Cancer | 36 | May 2009actual | — | 2010-07-26 |
| Individual Patient Expanded Access-Glembatumumab VedotinNCT03067935expanded access | — | No longer available | Drug: glembatumumab vedotin | Metastatic gpNMB Expressing Triple Negative Breast Cancer | — | — | — | 2018-05-21 |
| Expanded Access (Compassionate Use) Treatment Protocol RindopepimutNCT03068650expanded access | — | No longer available | Biological: rindopepimut | Recurrent GBM | — | — | — | 2017-10-18 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19