Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear RAPS Community:

My company is a target oncology biotech, and currently have an ongoing Phase 1 dose escalation (Part A) and dose expansion (Part B) study. We are rapidly approaching an optimized recommended dose for Part B. This is a global trial. In the U.S. we are planning to proceed into dose expansion phase, per protocol. In EU and South Korea, we want to understand if we are required to submit the dose escalation data (part A) to the health authorities and the justification for the dose selected for expansion (Part B), prior to initiating dose expansion? is this accurate?

Thank you.

This message was posted by a user wishing to remain anonymous

It depends on the class of drugs/biologics and the target disease! Say if you are dealing with an innovative mab, then the regulatory authorities including the FDA may request the dose escalation data first prior to allowing you to go to the expansion phase! Typically this is not the case for all drugs/biologics! Also if your preclinical data indicates any issues, the above path is likely from the authorities!
Original Message:
Sent: 18-Nov-2022 00:30
From: Anonymous Member
Subject: FDA Ph 1 dose escalation and dose expansion study - target oncology and RP2D

This message was posted by a user wishing to remain anonymous

Dear RAPS Community:

My company is a target oncology biotech, and currently have an ongoing Phase 1 dose escalation (Part A) and dose expansion (Part B) study. We are rapidly approaching an optimized recommended dose for Part B. This is a global trial. In the U.S. we are planning to proceed into dose expansion phase, per protocol. In EU and South Korea, we want to understand if we are required to submit the dose escalation data (part A) to the health authorities and the justification for the dose selected for expansion (Part B), prior to initiating dose expansion? is this accurate?

Thank you.

Yes, you will need to provide information regarding selected dose and submit it as substantial amendment in Europe.

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Olga Peycheva
Regulatory and Study Start Up Specialist
Solutions OP Ltd
olga.peycheva@solutionsop.co.uk
United Kingdom
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Original Message:
Sent: 18-Nov-2022 00:30
From: Anonymous Member
Subject: FDA Ph 1 dose escalation and dose expansion study - target oncology and RP2D

This message was posted by a user wishing to remain anonymous

Dear RAPS Community:

My company is a target oncology biotech, and currently have an ongoing Phase 1 dose escalation (Part A) and dose expansion (Part B) study. We are rapidly approaching an optimized recommended dose for Part B. This is a global trial. In the U.S. we are planning to proceed into dose expansion phase, per protocol. In EU and South Korea, we want to understand if we are required to submit the dose escalation data (part A) to the health authorities and the justification for the dose selected for expansion (Part B), prior to initiating dose expansion? is this accurate?

Thank you.