Trials Sponsors Conditions Drugs Pricing

Conditions

Relapsed/Refractory B-cell Malignancies

Outcome Measures

Primary Outcomes (3)

To evaluate the incidence and severity of Treatment-Emergent Adverse Events [Safety and Tolerability]
Assess incidence and severity of treatment-emergent adverse events as determined by CTCAE v5.0
Up to approximately 24 Months
To determine the MTD of MH048
If 2 or more treated subjects at a dose level experience a DLT before Day 28, dose escalation will stop and the prior dose level will be considered the MTD for that schedule.
At the end of Cycle 1( 28 day) of each dose escalation cohort.
To establish the RP2D.
The determination of RP2D for phase 2 according to the result of dose expansion cohorts.
Up to approximately 24 Months

Secondary Outcomes (6)

Characterization of Pharmacokinetics (Cmax)
At the end of Cycle 1 (each cycle is 28 days)
Characterization of Pharmacokinetics (AUC)
At the end of Cycle 1 (each cycle is 28 days)
Characterization of Pharmacokinetics (CL)
At the end of Cycle 1 (each cycle is 28 days)
Characterization of Pharmacokinetics (t1/2)
At the end of Cycle 1 (each cycle is 28 days)
Preliminary evidence of anti-tumor activity, in terms of Objective Response Rate (ORR)
From date of enrollment until the date of best overall response (BoR) of CR or PR, assessed up to approximately 24 months.
+1 more secondary outcomes

Study Arms (2)

Part A: Dose Escalation and Determination of RP2D

EXPERIMENTAL

Part A: Dose Escalation and determination of RP2D, multiple dose levels of MH048 to be evaluated

Drug: MH048

Part B: Dose Expansion in Selected Relapsed/Refractory B-cell Malignancies

EXPERIMENTAL

Part B: Selected relapsed/refractory B-NHL subjects with at least 1 prior systemic OR standard-of-care therapy.

Drug: MH048

Interventions

MH048Drug

Soft gel capsules 5 mg and 25 mg，oral MH048 should be administered after an overnight fast.

Also known as: MH048 Soft Gel Capsules

Part A: Dose Escalation and Determination of RP2DPart B: Dose Expansion in Selected Relapsed/Refractory B-cell Malignancies

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Male or female subjects ≥18 years of age;
Willing and able to understand and sign an informed consent form and to comply with all aspects of the protocol;

Sponsors & Collaborators

Minghui Pharmaceutical (Shanghai) LTD
Industrylead

Study Sites (1)

the First Affiliated Hospita，Medicine School of Zhejiang University

Hangzhou, Zhejiang, 310003, China

RECRUITING

Jie Jin, M.D.CONTACT+86-0571-87236114 jiej0503@163.com

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

Jie Jin, MD
79 Qingchun Road, Shangcheng District, Hangzhou, Zhejiang, China
PRINCIPAL INVESTIGATOR

Central Study Contacts

Jie Jin, MD

CONTACT

+86 057187236114 jiej0503@163.com

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SEQUENTIAL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 14, 2020

First Posted

December 30, 2020

Study Start

January 7, 2021

Actual (reported)

Primary Completion

June 30, 2023

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

You may not qualify if:

History of other active malignancies within 1 years of study entry, with the exception of adequately treated in-situ carcinoma of cervix, localized basal cell or squamous cell carcinoma of skin, previous malignancy that was not recurred in 5 years;
History of allogeneic or autologous stem cell transplant or chimeric antigen receptor-modified T-cell (CAR-T) therapy within the past 100 days before starting study treatment, or diagnosis of graft vs host disease;
Clinically significant, uncontrolled cardiac or cardiovascular disease, or history of myocardial infarction, New York Heart Association (NYHA) Class III or IV, QTc prolongation (defined as a QTc \> 450 ms) or other significant electrocardiogram (ECG) abnormalities including 2nd degree atrioventricular (AV) block type II, 3rd degree AV block, or bradycardia (ventricular rate less than 50 beats/min) ,within 6 months prior to planned start of MH048 treatment;
Transformation (e.g., Richter's transformation, prolymphocytic leukemia, or blastoid lymphoma) prior to the planned start of MH048 treatment;
Subjects with known or suspected history of allergy to MH048 capsules or excipients;
Any unresolved toxicities from prior therapy of National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (v5.0) Grade 2 or higher at the time of starting MH048 treatment, with the exception of toxicities not considered a safety risk (eg, alopecia, neuropathy, or asymptomatic laboratory abnormalities);
Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection;
Active uncontrolled autoimmune disease;
Clinically significant active malabsorption syndrome;
Subjects with human immunodeficiency virus (HIV) , Active hepatitis B virus (HBsAg positive, or HBsAg negative/HBcAb positive ，and HBV DNA\>10\^3) or Active HCV infection (HCVAb positive ,and HCV RNA positive);
Major surgery within 4 weeks prior to planned start of MH048 treatment (expect for biopsy, laser eye surgery)；
Women of childbearing potential who are pregnant or lactating;
Subjects requiring therapeutic anticoagulation;
Radiotherapy with a limited field of radiation for palliation within 7 days of the first dose of MH048 treatment;
Received a CYP3A4, CYP2A8 strong inhibitor or inducer within 5 half-lives of planned investigational product administration；
+4 more criteria

This is a Phase 1 Study of MH048 in Patients With Selected Relapsed/Refractory B-cell Malignancies

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (6)

Study Arms (2)

Part A: Dose Escalation and Determination of RP2D

Part B: Dose Expansion in Selected Relapsed/Refractory B-cell Malignancies

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (6)

Study Arms (2)

Part A: Dose Escalation and Determination of RP2D

Part B: Dose Expansion in Selected Relapsed/Refractory B-cell Malignancies

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations