Intas Pharma Gets CDSCO Panel Nod to Conduct Phase I Trial of Pertuzumab, Trastuzumab Solution for Injection

New Delhi: The Subject Expert Committee (SEC) functioning under the Central Drugs Standard Control Organisation (CDSCO) has granted approval to Intas Pharmaceuticals Limited to conduct a Phase I clinical trial of its fixed-dose combination Pertuzumab + Trastuzumab Solution for Injection (600 mg + 600 mg)/10 mL vial, developed as INTP78, intended for export purposes.

This came with the condition that the firm shall constitute an independent centralized Data and Safety Monitoring Board (DSMB) to monitor the proposed study. In addition, the expert panel stated that a consolidated report of Serious Adverse Events (SAEs) in the first 100 subjects (cumulative) shall be presented before the committee.

This approval follows Intas Pharmaceuticals’ presentation of the Phase I clinical trial protocol titled, "A randomized, double-blind, three-arm, balanced, single-dose, Phase I, Parallel-group study to compare the pharmacokinetics of INTP78 (Pertuzumab 600 mg, Trastuzumab 600 mg) (test product-T) of Intas Pharmaceuticals Limited, India, with the EU-licensed Phesgo (reference product- R1) and US-licensed Phesgo (reference product- R2) in normal, healthy, adult, human male subjects," vide Protocol Number: 0024-25, Version: 1.0 and Date: 15-May-2025 for export purposes.

Both pertuzumab and trastuzumab are monoclonal antibodies that target different sites on the HER2 protein. They block growth signals and help the immune system kill cancer cells, offering a more complete blockade than either drug alone.

The combination is used for early breast cancer (EBC) in combination with chemotherapy before and after surgery. It is also used for metastatic breast cancer (MBC) with docetaxel in patients who have not received prior anti-HER2 therapy for metastatic disease.

At the recent SEC meeting, the expert panel reviewed the full clinical trial protocol submitted by Intas.

After detailed deliberation, the committee recommended for the grant of permission to conduct the Phase I clinical trial as per the protocol presented by the firm, subject to the following conditions:

1. The firm shall constitute an independent centralized Data and Safety Monitoring Board (DSMB) to monitor the proposed study.

2. A consolidated report of SAEs in the first 100 subjects (cumulative) shall be presented before the committee.