A Phase 1b/2 Study of Oral HH2853 in Patients with Relapsed/Refractory Peripheral T-cell Lymphoma

JRCT ID: jRCT2031230059

Registered date:30/04/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Peripheral T-cell Lymphoma
• Date of first enrollment: 30/04/2023
• Target sample size: 100
• Countries of recruitment: China,Japan
• Study type: Interventional
• Intervention(s): HH2853 BID

Outcome(s)

• Primary Outcome: ORR

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.Be able to understand and voluntarily sign the informed consent form (ICF).
2.Male or female patients aged 18 years or older.
3.Tumor types:
Phase 1b
Dose Escalation: relapses or refractory NHL
Phase 1b dose expansion part and Phase 2:
relapses or refractory PTCL
4.All patients must have measurable lesions
5.Patients with prior radiotherapy can be enrolled
6.Availability of qualified tissue samples by patient for pathological diagnosis by the central laboratory.
7.The Eastern cooperative oncology group (ECOG) score 0-1
8. Life expectancy at least 3 months before starting HH2853 treatment.
9.Sufficient bone marrow, liver and renal functions without treatment with cell growth factor in 7 days, and platelet, red blood cell or blood transfusions in 14 days before the hematological evaluation during screening:
10.Requirement for sufficient time interval between the last antitumor treatment and the first administration of HH2853:

Exclude criteria

1.Previous treatment with EZH2 or EZH1/2 inhibitors.
2.Central nervous system invasion
3.Any previous history of bone marrow malignancy, including myelodysplastic syndrome (MDS).
4.Previous or current combination of other primary malignancies, or other malignant tumors.
5.Received medications that are known potent CYP3A4 inducers, inhibitors within 1 week prior to first dose.
6.Received inactivated vaccines and live attenuated vaccines within 2 weeks prior to first dose.
7.Any prior treatment related clinically significant toxicities have not resolved to Grade 0 or 1 per CTCAE version 5.01, or prior treatment related toxicities are clinically unstable and clinically significant at the time of enrollment.
8.Major surgery or significant traumatic injury within 4 weeks prior to the first dose of the study drug.
9.Inability to take oral medication, malabsorption syndrome or any other uncontrolled gastrointestinal condition that might impair the bioavailability of HH2853.
10.Clinically significant cardiovascular disease meeting
11.Known HIV infection with a history of acquired immunodeficiency syndrome (AIDS) defining opportunity infection within the past 12 months, active hepatitis B and hepatitis C.
12.Venous thrombosis or pulmonary embolism occurred within least 3 months before starting HH2853.
13.Any diseases or medical conditions that may be unstable or influence their safety or study compliance, including solid organ transplantation, abuse of psychotropic medication, alcohol abuse or history of drug abuse.
14.Other serious illnesses or medical conditions that, at the Investigators discretion, may influence study results, including serious infection, diabetes, cardiovascular and cerebrovascular diseases or lung disease.
15.Known to be allergic to any component of HH2853.
16.Any active interstitial lung disease (ILD), drug induced ILD, radiation pneumonia requiring or receiving steroid treatment.
17.There is a third space effusion that cannot be controlled by drainage or other methods.
18.Pregnant or breast feeding patients.
19.Males and females of childbearing potential.

Related Information

• Primary Sponsor: Onishi Shintaro