Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear RA Community with Oncology experience:

We are conducting a typical oncology Phase 1/1b dose escalation (part a) and dose expansion (part b) study. Our dose escalation is complete and we've selected an optimized dose for part b of the study (i.e. dose expansion). My question is, is there a requirement to notify FDA of the dose selected for expansion?

If your original protocol (i.e. submitted with your original IND) contained both Phase 1&1b parts and you received Safe to proceed letter after 30 days without any condition of submitting data for escalation phase first (i.e. phase 1a) prior to proceeding to phase 1b,  then you don't need to notify prior to proceeding with your Phase 1b. Have any questions reach out privately!

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GRSAOnline
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Original Message:
Sent: 19-Dec-2022 03:55
From: Anonymous Member
Subject: FDA notification of recommended dose for expansion in Ph 1 dose escalation/dose expansion oncology study

This message was posted by a user wishing to remain anonymous

Dear RA Community with Oncology experience:

We are conducting a typical oncology Phase 1/1b dose escalation (part a) and dose expansion (part b) study. Our dose escalation is complete and we've selected an optimized dose for part b of the study (i.e. dose expansion). My question is, is there a requirement to notify FDA of the dose selected for expansion?