NRC-2694 / NATCO - LARVOL DELTA

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 (clinicaltrials.gov) - P2 | N=21 | Active, not recruiting | Sponsor: NATCO Pharma Ltd. | Recruiting ➔ Active, not recruiting | N=30 ➔ 21 | Trial completion date: Jan 2026 ➔ Jun 2025 | Trial primary completion date: Jan 2026 ➔ Jun 2025

Checkpoint inhibition • Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

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 (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: NATCO Pharma Ltd. | Trial completion date: Jan 2025 ➔ Jan 2026 | Trial primary completion date: Dec 2024 ➔ Jan 2026 | N=46 ➔ 30

Checkpoint inhibition • Enrollment change • IO biomarker • Trial completion date • Trial primary completion date • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • EGFR

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 (clinicaltrials.gov) - P2 | N=46 | Recruiting | Sponsor: NATCO Pharma Ltd. | Trial completion date: Feb 2024 ➔ Jan 2025 | Trial primary completion date: Jan 2024 ➔ Dec 2024

Checkpoint inhibition • Combination therapy • IO biomarker • Metastases • Trial completion date • Trial primary completion date • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • EGFR

Oral NRC-2694-A in combination with paclitaxel as therapy for recurrent and/or metastatic head and neck squamous cell carcinoma (R/M-HNSCC) that progressed on or after an immune checkpoint inhibitor (ICI): A multi-center, single-arm, phase 2 trial. (ASCO 2023) - P2 | "The USFDA has approved two ICI agents to treat R/M-HNSCC: pembrolizumab given as monotherapy or with platinum-based chemotherapy for first-line treatment of R/M disease and nivolumab (or pembrolizumab) monotherapy for treatment of disease that progressed on or after platinum-containing chemotherapy...Drugs commonly used in this setting have limited activity and include cetuximab (an epidermal growth factor receptor [EGFR] inhibitor), paclitaxel, docetaxel, a platinum, or 5-fluorouracil...Enrolment to the NAT2694US trial is currently ongoing in USA. Clinical trial information: NCT05283226."

Checkpoint inhibition • Clinical • Combination therapy • Metastases • P2 data • Head and Neck Cancer • Immune Modulation • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

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 (clinicaltrials.gov) - P2 | N=46 | Recruiting | Sponsor: NATCO Pharma Ltd. | Not yet recruiting ➔ Recruiting | Initiation date: Mar 2022 ➔ Sep 2022 | Trial primary completion date: Jul 2023 ➔ Jan 2024

Checkpoint inhibition • Combination therapy • Enrollment open • Trial initiation date • Trial primary completion date • Head and Neck Cancer • Immune Modulation • Inflammation • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

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 (clinicaltrials.gov) - P2 | N=46 | Not yet recruiting | Sponsor: NATCO Pharma Ltd.

Checkpoint inhibition • Combination therapy • New P2 trial • Head and Neck Cancer • Immune Modulation • Inflammation • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck