A Study to Evaluate the Tolerability, Safety, Pharmacokinetics of HEC89736 in Patients With Relapsed or Refractory B-cell Hematologic Malignancies

Sunshine Lake Pharma

Status and phase: Unknown; Phase 1

Conditions: Relapsed or Refractory B-cell Hematologic Malignancies

Treatments: Drug: HEC89736

Study type: Interventional

Funder types: Industry

Identifiers

NCT04865458

HEC89736-P-01

Details and patient eligibility

About

Evaluate the safety, pharmacokinetics and efficacy of HEC89736 in patients with Relapsed or Refractory B-cell Hematologic Malignancies

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age is over 18 years old
• Histologically or cytologically diagnosed patients with recurrent or refractory B-cell malignancies
• ECOG performance status (PS) 0 ~ 1
• Expected survival of > or = 3 months

Exclusion criteria

• The use of PI3Ks as the target of anti-tumor drugs progress (due to intolerance group)
• Received any other anti-cancer treatment within 4 weeks
• Unable to swallow, chronic diarrhea and intestinal obstruction, there are many factors that affect drug use and absorption
• Allergy, or known to have a history of allergy to the drug components

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

HEC89736 treatment

Experimental group

Description:

HEC89736 tablets,25 mg, 50 mg, 100 mg, 150 mg, 200 mg, QD, 28 days for each cycle

Treatment:

Drug: HEC89736