Study on the Safety and Effects of HH2853

Sponsor: Haihe Biopharma Co., Ltd.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04390737

Provider View

This clinical trial is testing a new oral medication, HH2853, to determine its safety and effectiveness in treating certain types of cancer. The study is divided into three parts and involves taking the medication twice daily in 28-day cycles.

Patient Parameters

Program Overview

This study is designed to evaluate the safety and effectiveness of a new drug, HH2853, in treating specific types of cancer. The trial is divided into three parts: the first part focuses on finding the right dose, the second part extends the testing to more patients, and the third part involves a larger group of patients in China. Participants will take the medication orally twice a day in 28-day cycles.

Description

The study is divided into three phases:

Phase I:

  • Dose Escalation: This part aims to find the safest and most effective dose of HH2853. Patients will receive increasing doses until the best dose is found.
  • Dose Extension: Once a safe dose is identified, more patients will be treated at this dose to further evaluate its safety and how the body processes the drug.

Phase II (China Only):

  • This phase will involve more patients to further assess the drug's effectiveness in specific types of cancer, including relapsed or refractory follicular lymphoma, epithelioid sarcoma, and other cancers with certain genetic changes.

The study will include up to 60 patients in Phase I and approximately 193 patients in Phase II, focusing on different cancer types.

Eligibility Criteria

Inclusion Criteria

  • Must provide signed consent to participate.
  • Adults aged 18 or older.
  • Have specific types of cancer, such as:
    • Follicular lymphoma treated with at least two prior therapies.
    • Diffuse large B-cell lymphoma treated with at least two prior therapies.
    • Peripheral T-cell lymphoma treated with at least one prior therapy.
    • Advanced solid tumors that cannot be treated with surgery or radiation.
  • Must have measurable disease according to specific criteria.
  • Must have a life expectancy of at least 3 months.
  • Must meet certain blood and organ function requirements.
  • Must have a tumor sample available for testing.
  • Women of childbearing potential must agree to use contraception.

Exclusion Criteria

  • Recent cancer treatment within a specified time before starting the study.
  • Unstable brain metastases or requiring increasing steroid doses.
  • Previous transplant recipients.
  • Recent major surgery.
  • Use of certain medications that cannot be stopped.
  • Active infections like HIV, hepatitis B, or hepatitis C.
  • Other active cancers or previous cancers within a certain timeframe.
  • Use of certain blood thinners without reversal agents.
  • Unresolved side effects from previous treatments.
  • Certain bleeding disorders or use of blood-thinning medications.
  • Conditions affecting drug absorption.
  • Serious heart conditions or recent heart events.
  • Serious infections requiring antibiotics.
  • Allergies to similar drugs.
  • Pregnant or breastfeeding women.
  • Previous treatment with similar drugs.
  • Certain types of follicular lymphoma.

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