Study to Evaluate the Safety and Efficacy of Oral NRC-2694-A in Combination With Paclitaxel in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma, Who Progressed on or After Immune Checkpoint Inhibitor Therapy

Recruiting Phase 2 Interventional Study
Carcinoma Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
21 (estimated)
Sponsor
NATCO Pharma Ltd. · Industry
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About This Trial

This is a Phase 2, open-label, multicenter, single-arm study of NRC-2694-A in combination with paclitaxel in patients with R/M HNSCC with progression on or after ICI therapy. A total of approximately 46 male and female patients will be enrolled. This sample size is based on Simon's 2-stage design with historical control ORR of 30% and a target ORR of 50%.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Is willing and capable of understanding the written informed consent, provides signed and witnessed written informed consent, and agrees to comply with protocol requirements. * Is male or female aged 18 years or older at the time of consent. * Has histologically confirmed unre…
Contacts

Praveen Myneni, MBBS

+91 40 23547532

drpraveen@natcopharma.co.in

CONTACT