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NCT06935188

Dalpicilib Plus Cetuximab Compared With Cetuximab Alone in HPV-negative, Anti-PD-1-resistant R/M HNSCC

Recruiting now Phase 2 Last updated 18 July 2025
What this trial tests

Phase 2 trial testing Dalpicilib combined with cetuximab in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma in 98 participants. Currently enrolling.

Timeline
17 April 2025
Primary endpoint
31 December 2028
31 December 2030

Quick facts

Lead sponsorShanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
PhasePhase 2
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment98
Start date17 April 2025
Primary completion31 December 2028
Estimated completion31 December 2030
Sites1 location across China

Drugs / interventions tested

Conditions studied

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):

  1. 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:

Other recruiting trials for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Currently open trials in the same condition.

Other Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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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