RECRUITING

Evaluate the Safety and Clinical Activity of HH2853

Description

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 Overview

Study Details

Study overview

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.

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

Evaluate the Safety and Clinical Activity of HH2853

Condition
FL Lymphoma
Intervention / Treatment

-

Contacts and Locations

Phoenix

Mayo Clinic, Phoenix, Arizona, United States, 85054

Jacksonville

Mayo Clinic, Jacksonville, Florida, United States, 32224

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55905

San Antonio

NEXT Oncology, San Antonio, Texas, United States, 78240

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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:
  • 1. Histologically or cytologically documented advanced recurrent or metastatic solid tumor.
  • 2. Phase I dose escalation: Measurable or evaluable lesions by RECIST v1.1 in at least 1 site; phase I dose extension and phase II: Measurable target lesions by RECIST v1.1 in at least 1 site. (Lesions that have been treated with radiotherapy or other local treatment are generally considered unmeasurable unless there is definite progression of the lesion.)
  • 3. Patients must have disease not amenable to surgery, radiation, or combined modality therapy with curative intent. One of the following criteria should be met.
  • 1. Confirmed by local histology or cytology
  • 2. Patients with unresectable locally delayed or metastatic epithelioid sarcoma who have undergone treatment (including those who have failed treatment and developed intolerable toxicity).
  • 1. Confirmed by local pathology as advanced recurrent or metastatic solid tumor.
  • 2. Patients must have disease not amenable to surgery, radiation, or combined modality therapy with curative intent 4. Eastern Cooperative Oncology Group (ECOG) performance status ≤1; 5. Availability of archival tissue within three years 6. Relapsed/Refractory FL, Epithelioid sarcoma, relapsed/refractory PTCL, other relapsed/refractory non-Hodgkin's lymphomas with EZH2 mutation, and advanced solid tumors with specific genetic alterations, including EZH2 mutation, INI1 deficiency, BAP1 deficiency, ARID1A mutation, or/and SMARCA4 mutation 7. Predicted life expectancy of ≥ 3 months; 8. Patient must meet the following laboratory values: 1.Serum total Bilirubin ≤ 1.5 x ULN or ≤ 3.0 mg/dL for patients with Gilbert's syndrome 2.AST/SGOT and ALT/SGPT ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases are present 3.24-hour creatinine clearance (calculated\* or measured value\*\*)≥ 50 mL/min 4.Platelets ≥ 1 x LLN (no Platelet transfusion for 7 days prior to screening) 5.Hemoglobin (Hgb) ≥ 9 g/dL 6.Absolute Neutrophil Count (ANC) ≥ 1.0 x 10\^9/L 7.Adequate coagulation function: International normalized ratio (INR) \<1.3 (or \<3.0 on anticoagulants) 9. Measurable lesion
  • 1. Any 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.
  • 2. Symptomatic CNS metastases that are neurologically unstable or requiring increasing doses of steroids to control CNS disease.
  • 3. Patients with prior transplant are excluded;
  • 4. Major surgery within 4 weeks prior to first dose;
  • 5. A prohibited medication or expected to require any of these medications during treatment with study drug within 2 weeks of first dose;
  • 6. HIV (human immunodeficiency virus) infection, active hepatitis B or hepatitis C patients (HBsAg positive patients with HBV (hepatitis B virus) DNA ≥ 10\^3 copies or ≥ 200 IU/mL; HCV antibody test results are positive, and HCV (hepatitis C virus) RNA PCR test results are positive).
  • 7. Concomitant malignancies or previous malignancies
  • 8. Concurrent use of therapeutic warfarin is allowed. However, anticoagulants that do not have reversal agents available are prohibited except low molecular weight heparin and direct oral anticoagulants.
  • 9. Any toxicities from prior treatment that have not recovered to ≤ CTCAE Grade 1
  • 10. There were ≥ 3 lesions with punctate bleeding, any active bleeding, intratumoral bleeding, known bleeding tendencies, or treatment with antiplatelet/antithrombotic drugs.
  • 11. Gastrointestinal condition which could impair absorption of study medication;
  • 12. Psychological, familial, sociological or geographical conditions that do not permit compliance with the protocol;
  • 13. Cardiac

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Haihe Biopharma Co., Ltd.,

Fugen Li, STUDY_DIRECTOR, Haihe Biopharma Co., Ltd.

Study Record Dates

2025-12-31