Last reviewed · How we verify
NCT06935188
Dalpicilib Plus Cetuximab Compared With Cetuximab Alone in HPV-negative, Anti-PD-1-resistant R/M HNSCC
Phase 2 trial testing Dalpicilib combined with cetuximab in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma in 98 participants. Currently enrolling.
31 December 2028
Quick facts
| Lead sponsor | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 98 |
| Start date | 17 April 2025 |
| Primary completion | 31 December 2028 |
| Estimated completion | 31 December 2030 |
| Sites | 1 location across China |
Drugs / interventions tested
- Dalpicilib combined with cetuximab — full drug profile →
- cetuximab (cetuximab) — full drug profile →
Conditions studied
- Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma — all drugs for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma →
Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Who can join
Adults 18 to 75, any sex, with Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is a single center, randomized controlled, prospective phase II clinical trial to evaluate the efficacy and safety of cetuximab combined with dalpicilib compared to cetuximab monotherapy in patients with HPV-negative, anti-PD-1-resistant recurrent or metastatic head and neck squamous cell carcinoma. The participants would receive cetuximab combined with dalpicilib or cetuximab monotherapy until termination criteria are met.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Drug resistance in cancer: molecular mechanisms and emerging treatment strategies.
Li J, Hu J, Yang Y, Zhang H, et al · · 2025 · cited 5× · PMID 41247642 · DOI 10.1186/s43556-025-00352-w
Verify or expand the search:
- PubMed search for NCT06935188
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Currently open trials in the same condition.
- NCT07088211 — Sacituzumab Tirumotecan and Toripalimab in the First-line Treatment of HNSCC · Phase 2 · recruiting
- NCT07090317 — Iparomlimab and Tuvonralimab in HNSCC · Phase 2 · recruiting
Other Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University trials
Trials by the same sponsor.
- NCT07535567 — Postoperative Radiotherapy With Nimotuzumab ± Benmelstobart in Intermediate-Risk Head and Neck Squamous Cell Carcinoma: · Phase 2, PHASE3 · not yet recruiting
- NCT07505251 — Development and Validation of the Periodontal Map Derived From IOS and CBCT Registration for Diagnosis and Treatment Pla · not yet recruiting
- NCT07466810 — Resection and Defect Repair of Oral Cancer Aided by Mixed Reality Technology · NA · not yet recruiting
- NCT07533695 — Impact of Day 2 Versus Day 3 Fresh Embryo Transfer on Live Birth Rate in Poor-Prognosis Patients · NA · not yet recruiting
- NCT07490561 — The Impact of Assisted Hatching on Pregnancy Outcomes After Vitrified-Warmed Embryo Transfer in Advanced-age Patients · NA · 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 NCT06935188 (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 Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Last refreshed: 18 July 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/NCT06935188.
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