Squamous Cell Carcinoma of Head and Neck Clinical Trial
Official title:
Phase 1 Dose Escalation Study of the Agonist Redirected Checkpoint, SL-172154 (SIRPĪ±-Fc-CD40L), Administered Intratumorally in Subjects With Cutaneous Squamous Cell Carcinoma or Squamous Cell Carcinoma of the Head and Neck
This is a Phase 1 open-label, multi-center, dose-escalation study to evaluate the safety, PK, anti-tumor activity, and pharmacodynamic effects of SL-172154 administered by intratumoral injection in subjects with cutaneous squamous cell carcinoma (CSCC) or squamous cell carcinoma of the head and neck (SCCHN).
This Phase 1 trial will evaluate the safety, tolerability, pharmacokinetics, anti-tumor activity and pharmacodynamic effects of SL-172154 when administered as an intratumoral injection (ITI) and identify the dose and schedule i.e., recommended Phase 2 dose (RP2D) for future development. Eligible subjects must have unresectable or recurrent, locally advanced or metastatic squamous cell carcinoma of the skin or head and neck, that is not amenable to curative surgery or radiotherapy. The study design consists of four sequential dose-escalation cohorts and an optional pharmacodynamic cohort to obtain additional pharmacodynamic data at one or more dose levels that have completed evaluation for safety without exceeding the maximum tolerated dose (MTD). ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04879849 -
A Study of TAK-676 With Pembrolizumab After Radiation Therapy to Treat a Number of Cancers
|
Phase 1 | |
| Active, not recruiting |
NCT04474470 -
A Study to Evaluate NT219 Alone and in Combination With ERBITUX® (Cetuximab) in Adults With Advanced Solid Tumors and Head and Neck Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT02537223 -
Phase I Study of BYL719 in Combination With Cisplatin and Radiotherapy in Patients With Squamous Cell Head and Neck Cancer
|
Phase 1 | |
| Completed |
NCT00824343 -
A Phase II Clinical Trial to Study the Efficacy and Safety of a New Drug P276-00 in Treatment of Recurrent and/or Locally Advanced Head and Neck Cancer
|
Phase 2 | |
| Recruiting |
NCT06022757 -
Study of XNW5004 Tablet in Combination With KEYTRUDA® (Pembrolizumab) in Subjects With Advanced Solid Tumors Who Failed Standard Treatments (KEYNOTE F19)
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05366166 -
Pembrolizumab Plus Olaparib in LA-HNSCC
|
Phase 2 | |
| Recruiting |
NCT05007106 -
MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005)
|
Phase 2 | |
| Completed |
NCT04098458 -
Navigation for Timely Adjuvant Therapy for Patients With Locally Advanced HNSCC
|
N/A | |
| Not yet recruiting |
NCT04528420 -
Optimised Early Management of Squamous Cell Carcinoma of the Head and Neck Cancer
|
N/A | |
| Active, not recruiting |
NCT03997968 -
A Phase 1/2 Study of CYT-0851 in B-Cell Malignancies and Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT05061420 -
A Study of SAR444245 Combined With Other Anticancer Therapies for the Treatment of Participants With HNSCC (Master Protocol) (Pegathor Head and Neck 204)
|
Phase 2 | |
| Completed |
NCT04939480 -
Window of Opportunity Study of Preoperative Immunotherapy With Atezolizumab in Local SCCHN
|
Phase 2 | |
| Recruiting |
NCT04260802 -
A Study to Evaluate the Safety and Pharmacokinetics of OC-001 in Patients With Locally Advanced or Metastatic Cancers
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04465487 -
Study of REGN6569 and Cemiplimab in Adult Patients With Advanced Solid Tumor Malignancies
|
Phase 1 | |
| Not yet recruiting |
NCT05845307 -
Randomized Pre-surgical Window-of-Opportunity Trial of TTI-101 in Patients With Stage II-IV Resectable HPV-negative Squamous Cell Carcinoma of the Head and Neck
|
Early Phase 1 | |
| Active, not recruiting |
NCT04489888 -
A Study of Pembrolizumab (MK-3475) Plus Carboplatin and Paclitaxel as First-line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (MK-3475-B10/KEYNOTE B10)
|
Phase 4 | |
| Recruiting |
NCT05544929 -
A Study of Safety and Efficacy of KFA115 Alone and in Combination With Pembrolizumab in Patients With Select Advanced Cancers
|
Phase 1 | |
| Completed |
NCT04601402 -
GEN-001 (Live Biotherapeutic Product) and Avelumab Combination Study for Patients With Solid Tumors Who Have Progressed on Anti-PD-(L)1 Therapy
|
Phase 1 | |
| Completed |
NCT00756444 -
A Randomized Phase 2 Pharmacokinetic Trial of Chemotherapy With or Without Panitumumab in Patients With Metastatic and/or Recurrent Squamous Cell Carcinoma of the Head and Neck
|
Phase 2 | |
| Withdrawn |
NCT04129320 -
Enoblituzumab Plus MGA012 or MGD013 in Squamous Cell Carcinoma of the Head and Neck
|
Phase 2/Phase 3 |