Clinical trial · Interventional
A Study of the PD-L1xCD27 Bispecific Antibody CDX-527 in Patients With Advanced Malignancies
A Phase 1 Study of the PD-L1xCD27 Bispecific Antibody CDX-527 in Patients With Advanced Malignancies
NCT04440943CI-TRIAL-00067308completedPhase 1ClinicalTrials.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)
This is an open-label, non-randomized, multicenter, dose-escalation and expansion study in patients with selected solid tumors.
Conditions
Conditions (14)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Urothelial Carcinoma | Bladder Urothelial Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Hepatic Cancer | — | UNRESOLVED | — |
| MSI-H Colorectal Cancer | MSI-H Colorectal Carcinoma | ALIAS |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CDX-527 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CDX-527
- description
- 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.
- interventionNames
- Drug: CDX-527
Primary outcomes (1)
- measure
- Safety and Tolerability of CDX-527 as assessed by CTCAE v5.0
- timeFrame
- From first dose through 28 days after last dose
- description
- The rates of drug-related adverse events will be summarized and maximum tolerated dose will be determined.
Secondary outcomes (7)
- measure
- Objective Response Rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.