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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_PHASE1 trial testing Control Group in Squamous Cell Carcinoma of Head and Neck. Withdrawn.
13 November 2025
Quick facts
| Lead sponsor | M.D. Anderson Cancer Center |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Start date | 20 June 2025 |
| Primary completion | 13 November 2025 |
| Estimated completion | 13 November 2025 |
Drugs / interventions tested
- Control Group — full drug profile →
- TTI-101 — full drug profile →
Conditions studied
- Squamous Cell Carcinoma of Head and Neck — all drugs for Squamous Cell Carcinoma of Head and Neck →
Sponsor
M.D. Anderson Cancer Center — full company profile →
Who can join
18 and older, any sex, with Squamous Cell Carcinoma of Head and Neck. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To learn if TTI-101 can reduce the growth of HPV-negative squamous cell carcinomas of the head and neck when given before standard of care surgery.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
STAT3: Key targets of growth-promoting receptor positive breast cancer.
Jiang RY, Zhu JY, Zhang HP, Yu Y, et al · · 2024 · cited 17× · PMID 39468521 · DOI 10.1186/s12935-024-03541-9
Verify or expand the search:
- PubMed search for NCT05845307
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Squamous Cell Carcinoma of Head and Neck
Currently open trials in the same condition.
- NCT07455032 — Neoadjuvant CADI-05 in Combination With Pembrolizumab for Surgically Resectable Locally Advanced Head and Neck Squamous · Phase 1 · recruiting
- NCT07219212 — A Study of JNJ-90301900 in Combination With Chemoradiation Therapy in Participants With Locally Advanced Head and Neck S · Phase 1 · recruiting
- NCT07276399 — A Study of Amivantamab in Addition to Standard of Care Agents (SOC) Compared With SOC Alone in Participants With Recurre · Phase 3 · recruiting
- NCT07063212 — A Study of Sacituzumab Govitecan in Combination With Cetuximab in People With Head and Neck Squamous Cell Cancer (HNSCC) · Phase 2 · recruiting
- NCT06487403 — HN-BIO 02: A Phase II Randomized Study of the Effects of Delayed Elective Radiotherapy on Head and Neck MRI and Immune R · NA · recruiting
Other M.D. Anderson Cancer Center trials
Trials by the same sponsor.
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- NCT07162480 — Phase II Trial of Puxitatug Samrotecan (AZD8205) in Advanced, Recurrent or Metastatic (R/M) Aggressive Adenoid Cystic Ca · Phase 2 · not yet recruiting
- NCT07076498 — Engineered HSV-1 M032 for the Treatment of Children and Adults With Newly Diagnosed Diffuse Midline Glioma After Standar · Phase 1 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05845307 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by M.D. Anderson Cancer Center
- Last refreshed: 8 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05845307.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing