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Phase 1 / Phase 2 Clinical Trials
Phase 1/2 combined trials evaluate both safety (Phase 1) and preliminary efficacy (Phase 2) in a single study protocol, often used to accelerate early development.
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Frequently Asked Questions — Phase 1 / Phase 2 Trials
What are combined Phase 1/2 clinical trials?
Phase 1/2 trials are adaptive designs that evaluate both safety (Phase 1 objectives) and preliminary efficacy (Phase 2 objectives) within a single trial protocol. They are commonly used in oncology and rare disease research to accelerate development timelines. Dose escalation occurs in the Phase 1 portion, followed by expansion cohorts at the selected dose in the Phase 2 portion.
Why do sponsors combine Phase 1 and Phase 2?
Combining phases reduces development time and cost, particularly for conditions with high unmet need. For rare diseases or cancer indications, finding sufficient eligible patients can be challenging—a combined design uses the same patient pool more efficiently. Regulatory agencies including the FDA encourage adaptive designs to accelerate evidence generation for serious conditions.
How do I find Phase 1/2 trials I can join?
Phase 1/2 trials listed on ClinicalMetric are sourced from ClinicalTrials.gov and filtered by recruitment status. Each listing shows enrollment status, conditions studied, sponsor, participating sites, and estimated enrollment. Because Phase 1/2 trials often have narrow eligibility criteria, carefully review the protocol and discuss potential participation with your treating physician.
Active Phase 1 / Phase 2 Studies
ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer · Last Reviewed: April 2026 · Data Methodology