Clinical trial · Interventional
Study of SCB01A in Patient With Head and Neck Cancer
An Open-Label, Phase II Study to Evaluate SCB01A in Patients With Recurrent or Metastatic Squamous Cell Head and Neck Cancer Who Have Received Platinum-Based Treatment
NCT02488629CI-TRIAL-00067572terminatedPhase 2Results postedClinicalTrials.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)
To evaluate the safety and efficacy of SCB01A in 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 Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SCB01A | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SCB01A
- description
- This study is a single arm, open-label, Phase II trial
- interventionNames
- Drug: SCB01A
Primary outcomes (1)
- measure
- Disease Control Rate (DCR)
- timeFrame
- 9 weeks from 1st administrationm drug
- description
- To assess the DCR (=complete response (CR) + partial response (PR) + stable disease (SD)) at the end of the 9th week (3 cycles, each cycle consisted of 21 days) after treatment with SCB01A, according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sumdiameterswhile on study.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: 1. Confirmed squamous cell carcinoma of head and neck 2. Patients with nonresectable, unfeasible radiotherapy, recurrent or metastatic carcinoma, after previous treatment with platinum agent. 3. At least one measurable tumor lesion according to RECIST 4. Suitable Eastern Cooperative Oncology Group (ECOG) performance status 5. All eligible patients of childbearing potential have to use effective contraception 6. Signed informed consent before enrolment Exclusion Criteria: 1. Receiving Chemotherapy, radiation therapy, major surgery or investigational agents 2. Severe pulmonary obstructive or restrictive disease 3. Uncontrolled inflammatory disease 4. Clinically significant cardiac disease 5. Results of laboratory tests 6. Pregnancy or nursing status 7. Known hypersensitivity to any component of SCB01A 8. History of exposure to SCB01A or its analogues 9. History of malignancy other than head and neck cancer 10. History of active or significant neurological disorder or psychiatric disorder 11. Any other reason the investigator deems the patient to be unsuitable for the study
References
Publications (0)
Data not yet available
No reference posted for this study.