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# Cancer Trials Guide Calls for Broader Eligibility, Flexible Dose Escalation
- URL: https://www.fdaweb.com/cancer-trials-guide-calls-for-broader-eligibility-flexible-dose-escalation/
- Published: 2026-11-10T17:49:35.000Z
- Updated: 2026-11-10T17:49:35.000Z
- Author: David McFarland
- Tags: Drugs, Biologics

FDA is recommending less restrictive patient eligibility criteria and more flexible dose-escalation strategies in early-phase clinical trials for solid tumors, under a new draft guidance addressing common deficiencies identified during the agency's review of INDs.

The [draft guidance](https://www.fda.gov/media/196814/download?ref=fdaweb.com), *Early-Phase IND Protocol Recommendations for Solid Tumors*, provides recommendations for first-in-human studies and trials involving investigational drugs and biologics with limited human experience. It addresses eligibility criteria, dose escalation, dose-limiting toxicities, expansion cohorts, dose optimization and safety monitoring.

FDA cautions that unnecessarily restrictive eligibility criteria can delay enrollment, limit access to experimental treatments and produce findings that are less representative of patients who would ultimately receive the drugs.

Among its recommendations, the agency discourages arbitrary upper age limits and generally advises against fixed washout periods between treatments unless scientifically justified. It also encourages appropriate inclusion of patients with brain metastases and those with HIV or hepatitis B or C.

For patients with cancer in noncurative settings, FDA says prior receipt of available therapies should not necessarily be required for enrollment in early-phase trials. However, patients should receive available treatments offering a potential cure, or those treatments should be incorporated into the investigational regimen.

The guidance also encourages timely pediatric enrollment when sufficient evidence supports a prospect of clinical benefit and risks can be adequately managed.

For dose-escalation studies, FDA discusses approaches to selecting doses, identifying dose-limiting toxicities and determining recommended Phase 2 doses, emphasizing the need to consider both safety and evidence of antitumor activity.

The agency recommends that sponsors discuss unusual disease settings and novel therapies with FDA before submitting IND protocols.