Clinical trial · Interventional
A Study of CDX-1401 in Patients With Malignancies Known to Express NY-ESO-1
A Phase I/II, Open-Label, Dose-Escalation Study of CDX-1401 in Patients With Malignancies Known to Express NY-ESO-1
NCT00948961CI-TRIAL-00022733completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The main purpose of this study is to examine the safety and tolerability of CDX-1401 when given in combination with an immune stimulant (resiquimod) to patients with advanced cancers that are known to express the NY-ESO-1 protein.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CDX-1401 | Biological | — | UNRESOLVED |
| CDX-1401 in combination with Resiquimod and/or Poly-ICLC | Biological | — | UNRESOLVED |
| poly-ICLC | Biological | — | UNRESOLVED |
| Resiquimod | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Occurrence of adverse events (side effects)
- timeFrame
- 12 weeks (1 cycle of study treatment)
Secondary outcomes (1)
- measure
- Objective response rate (CR/PR), disease control rate (CR/PR/SD) and time to progression, based on disease-appropriate response criteria.
- timeFrame
- 12 week intervals
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: Among other criteria, patients must meet all of the following conditions to be eligible to be in the study: 1. 18 years of age or older. 2. Have a cancer type that is known to express NY-ESO-1, including (but not limited to) cancer of the bladder, breast, ovary, non-small cell lung cancer, myeloma, sarcoma or melanoma. 3. Have cancer that has progressed after any therapies with curative potential or approved salvage therapies (if such therapies exist). 4. Have evaluable or measurable tumors. 5. Have adequate blood, bone marrow, liver and kidney function as determined by laboratory tests. 6. Have a sample of tumor tissue available for NY-ESO-1 testing at a central laboratory. 7. If of childbearing potential (male or female), agree to practice an effective form of contraception during study treatment. Exclusion Criteria: Among other criteria, patients who meet any of the following conditions are NOT eligible to be in the study: 1. Are receiving treatment with immunosuppressive or immunomodulatory agents, including any systemic steroid (inhaled or topically applied steroids are permitted). 2. Has a known infection with HIV, HBV or HCV, or any other active infection requiring systemic antibiotic treatment. 3. Has active central nervous system tumors. 4. Any underlying medical condition that in the Principal Investigator's opinion will make the administration of study drug hazardous or otherwise interfere with the study.
References
Publications (1)
- RESULTDhodapkar MV, Sznol M, Zhao B, Wang D, Carvajal RD, Keohan ML, Chuang E, Sanborn RE, Lutzky J, Powderly J, Kluger H, Tejwani S, Green J, Ramakrishna V, Crocker A, Vitale L, Yellin M, Davis T, Keler T. Induction of antigen-specific immunity with a vaccine targeting NY-ESO-1 to the dendritic cell receptor DEC-205. Sci Transl Med. 2014 Apr 16;6(232):232ra51. doi: 10.1126/scitranslmed.3008068. PMID 24739759