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

Part of paid clinical trials in Fullerton, California.

Sponsor
NATCO Pharma Ltd.
Study ID
NCT05283226
Phase
PHASE2
Status
Recruiting
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Conditions

  • Carcinoma
  • Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • NRC-2694-A — DRUG
    300 mg orally once daily
  • Paclitaxel — DRUG
    175 mg/m² IV infusion over approximately 3 hours

Study Details

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%.

Key Dates

Start date
Sep 30, 2022
Status verified
Jan 2026
Primary completion
Dec 30, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
21 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: NRC-2694-A In Combination with paclitaxel
    Patients will receive NRC-2694-A 300 mg orally once daily and paclitaxel 175 mg/m² IV infusion over approximately 3 hours once in 21 days for 6 cycles or more.

Primary Outcome Measure

To determine if NRC-2694-A administered orally in combination with paclitaxel demonstrates objective response in patients with R/M HNSCC, who have had radiological progression on or after treatment with ICI therapies like pembrolizumab or nivolumab [ Time Frame: Baseline through approximately up to 24 weeks ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Providence Medical Foundation -FullertonFullertonCalifornia92835-
Los Angeles Hematology Oncology Medical GroupLos AngelesCalifornia90017-
Lynn Cancer CenterBoca RatonFlorida33486-
Miami Cancer CenterMiamiFlorida33176-
Norton Cancer Institute - DowntownLouisvilleKentucky40202-
University of Maryland Greenebaum Cancer CenterBaltimoreMaryland21201-1544-
Washington University - Siteman Cancer CenterSt LouisMissouri63110-
Dartmouth Hitchcock Medical CenterLebanonNew Hampshire03756-1000-
Salib OncologyEastonPennsylvania18045-
University of Wisconsin Carbone Cancer CenterMadisonWisconsin53792-

Find similar trials in Fullerton, CA

By research site
Providence Medical Foundation -Fullerton· Fullerton, CALos Angeles Hematology Oncology Medical Group· Los Angeles, CALynn Cancer Center· Boca Raton, FLMiami Cancer Center· Miami, FLNorton Cancer Institute - Downtown· Louisville, KYUniversity of Maryland Greenebaum Cancer Center· Baltimore, MD

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