At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years at time of consent
- ✓Histologically confirmed follicular lymphoma Grade 1-3a treated with ≥2 systemic lines including ≥1 anti-CD20 monoclonal antibody
- ✓Relapsed/refractory DLBCL NOS with ≥2 prior treatment regimens (≥1 with anti-CD20), maximum <5 lines, not candidate for salvage/stem cell transplant
- ✓Relapsed/refractory PTCL with ≥1 prior systemic line, maximum <5 lines
- ✕Cancer-directed therapy within 28 days or five half-lives prior to first dose
- ✕Small molecule anticancer therapy within 2 weeks or five half-lives
- ✕Local radiotherapy within 14 days of first dose
- ✕Symptomatic CNS metastases that are neurologically unstable or requiring increasing doses of steroids
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of HH2853 in Patients With Relapsed/Refractory Non-Hodgkin's Lymphomas or Advanced Solid Tumors
In Brief
A Phase 2 clinical trial evaluating HH2853 Tablets for FL Lymphoma and 3 related conditions. Currently recruiting, targeting 254 participants across 25 sites in 2 countries.
Signals
Detailed Summary
This is an open-label, multicenter, first-in-human phase I/II study which is composed of 3 parts: phase I dose escalation, phase I dose extension and phase II. HH2853 will be administered orally on a continuous BID schedule on a continuous 28-day treatment cycle.
Study Details
Timeline
Interventions
Proposed daily dose (BID): 50mg, 100mg, 200mg, 400mg, 600mg, 800mg, 1000mg. It is possible for additional and/or intermediate dose levels to be added during the course of the study. Cohorts may be added at any dose level below the MTD in order to better understand safety, PK or PD.