Clinical trial · Interventional
SPEARHEAD 2 Study in Subjects With Recurrent or Metastatic Head and Neck Cancer
A Phase 2 Pilot Study of ADP-A2M4 in Combination With Pembrolizumab in Subjects With Recurrent or Metastatic Head and Neck Cancer
NCT04408898CI-TRIAL-00055045withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Challenges with recruitment
Summary
Brief summary (as posted)
This is a study to investigate the efficacy and safety of ADP-A2M4 in combination with pembrolizumab in HLA-A\*02 eligible and MAGE-A4 positive subjects with recurrent or metastatic Head and Neck cancer.
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 |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ADP-A2M4 in combination with pembrolizumab. | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ADP-A2M4 T cells in combination with pembrolizumab
- interventionNames
- Genetic: ADP-A2M4 in combination with pembrolizumab.
Primary outcomes (1)
- measure
- Efficacy: Overall Response Rate (ORR)
- timeFrame
- 2.5 years
- description
- ORR is defined as the proportion of complete responses or partial responses as assessed by RECIST v1.1
Secondary outcomes (9)
- measure
- Best overall response (BOR)
- timeFrame
- 2.5 years
- description
- BOR defined as the best response recorded from the date of T cell infusion until disease progression.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Key Inclusion Criteria * Age ≥18 and \<75 years * Diagnosis of head and neck squamous cell carcinoma with metastatic or unresectable, recurrent disease. confirmed by histology cytology. * Checkpoint inhibitor naïve and indicated for pembrolizumab or currently receiving pembrolizumab (monotherapy). May have received prior platinum containing chemotherapy regimen or checkpoint inhibitor therapy. * Subjects that have already received pembrolizumab (alone or in combination) and are progressing or have completed immune checkpoint inhibitor therapy for recurrent/metastatic disease, may still be enrolled and will skip Part A of the study. These subjects will enroll into Part B when manufactured T cells are available. * Measurable disease according to RECIST v1.1. * HLA-A\*02 positive by central laboratory. * Tumor shows MAGE-A4 expression confirmed by central laboratory. * ECOG Performance Status of 0 or 1. * Left ventricular ejection fraction (LVEF) ≥50%. Note: other protocol defined Inclusion criteria may apply Key Exclusion Criteria: * Positive for any HLA-A\*02 allele other than: one of the inclusion alleles, HLA- A\*02:07P or HLA-A\*02 null alleles * History of allergic reactions attributed to compounds of similar chemical or biologic composition to fludarabine, cyclophosphamide or other agents used in the study or history of severe hypersensitivity to another monoclonal antibody. * History of autoimmune or immune mediated disease * Leptomeningeal disease, carcinomatous meningitis or CNS metastases. * Other prior malignancy that is not considered by the Investigator to be in complete remission * Clinically significant cardiovascular disease * Uncontrolled intercurrent illness * Active infection with human immunodeficiency virus, hepatitis B virus, hepatitis C virus, or human T cell leukemia virus * Pregnant or breastfeeding Note: other protocol defined Exclusion criteria may apply.
References
Publications (0)
Data not yet available
No reference posted for this study.