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OncoMatch/Clinical Trials/NCT04390737

Evaluate the Safety and Clinical Activity of HH2853

Is NCT04390737 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies HH2853 Tablets for fl lymphoma.

Phase 1/2RecruitingHaihe Biopharma Co., Ltd.NCT04390737Data as of May 2026

Treatment: HH2853 TabletsThis 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.

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Extracted eligibility criteria

Cancer type

Non-Hodgkin Lymphoma

Sarcoma

Tumor Agnostic

Biomarker criteria

Required: EZH2 mutation

other relapsed/refractory non-Hodgkin's lymphomas with EZH2 mutation, and advanced solid tumors with specific genetic alterations, including EZH2 mutation

Required: SMARCB1 deficiency

advanced solid tumors with specific genetic alterations, including ... INI1 deficiency

Required: BAP1 deficiency

advanced solid tumors with specific genetic alterations, including ... BAP1 deficiency

Required: ARID1A mutation

advanced solid tumors with specific genetic alterations, including ... ARID1A mutation

Required: SMARCA4 mutation

advanced solid tumors with specific genetic alterations, including ... SMARCA4 mutation

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Max 4 prior lines

Must have received: systemic therapy (anti-CD20 monoclonal antibody)

at least two lines of systemic therapy (at least one regimen based on anti-CD20 monoclonal antibodies)

Must have received: systemic therapy (CD20 monoclonal antibody)

at least two treatment regimens in the past (at least one with CD20 monoclonal antibody as the main treatment, with a maximum number of treatment lines<5)

Must have received: systemic therapy

Relapsed/refractory clinicopathologically documented PTCL with at least 1 line of prior systemic treatment (maximum <5 lines)

Must have received: any standard therapy

Patients must experience at least one prior standard therapy. Disease progression occurred on or after last line of therapy, or intolerant to last line of therapy (maximum ≤3 lines, Patients without treatment options available known to provide clinical benefit are also eligible upon agreement from investigator and sponsor)

Must have received: any treatment

Patients with unresectable locally delayed or metastatic epithelioid sarcoma who have undergone treatment (including those who have failed treatment and developed intolerable toxicity)

Cannot have received: EZH2 or EZH1/2 inhibitor

Previously received treatment with EZH2 or EZH1/2 inhibitors

Cannot have received: transplant

Patients with prior transplant are excluded

Lab requirements

Blood counts

Platelets ≥ 1 x LLN (no Platelet transfusion for 7 days prior to screening); Hemoglobin (Hgb) ≥ 9 g/dL; Absolute Neutrophil Count (ANC) ≥ 1.0 x 10^9/L; Adequate coagulation function: International normalized ratio (INR) <1.3 (or <3.0 on anticoagulants)

Kidney function

24-hour creatinine clearance (calculated or measured value) ≥ 50 mL/min

Liver function

Serum total Bilirubin ≤ 1.5 x ULN or ≤ 3.0 mg/dL for patients with Gilbert's syndrome; AST/SGOT and ALT/SGPT ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases are present

Cardiac function

QTcF > 450 ms (male) or > 470 ms (female) excluded; LVEF < 50% excluded; NYHA Class III/IV heart failure within 3 months excluded; history of acute coronary syndromes, coronary angioplasty, or stenting within 3 months excluded; congenital long QT syndrome, torsade de pointes, or family history of unexplained sudden death excluded; serious uncontrolled ventricular arrhythmias excluded

Patient must meet the following laboratory values: ... Cardiac exclusion criteria: ... (see above for details)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Mayo Clinic · Phoenix, Arizona
  • Mayo Clinic · Jacksonville, Florida
  • Mayo Clinic · Rochester, Minnesota
  • NEXT Oncology · San Antonio, Texas

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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