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
Haihe Biopharma Co., Ltd.
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.
Description
Phase I: Phase I dose escalation The accelerated titration (ATD) incorporated with Bayesian Optimal Interval design (BOIN) will be used to assess the DLT, safety, tolerability, MTD and furthermore, to establish the RP2D. DLT assessment is only applicable to phase I dose escalation. Eligible patients will be enrolled in the ascending dose until MTD/RP2D is established. Phase I dose extension During the dose escalation phase, a dose extension with additional patients will be included in order to further evaluate the tolerability, pharmacokinetics, and efficacy at doses that have been evaluate…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion criteria: 1. Provided signed written informed consent prior to initiation of any study-related procedures; 2. Males and females ≥ 18years of age at the time of consent are obtained (or meet the country's regulatory defined adult legal age); 3. Tumor type criteria: The specific requirements for specific subtypes of recurrent/refractory non Hodgkin's lymphoma (NHL) confirmed by histology are as follows: Histologically confirmed follicular lymphoma (FL) that has been treated with at least two lines of systemic therapy (at least one regimen based on anti-CD20 monoclonal antibodies) ac…
Interventions
- DrugHH2853 Tablets
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.
Locations (25)
- Mayo ClinicPhoenix, Arizona
- Mayo ClinicJacksonville, Florida
- Mayo ClinicRochester, Minnesota
- NEXT OncologySan Antonio, Texas
- The First Affiliated Hospital of Anhui Medical UniversityHefei, Anhui
- Beijing Cancer HospitalBeijing, Beijing Municipality