Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05176691




Registration number
NCT05176691
Ethics application status
Date submitted
19/11/2021
Date registered
4/01/2022
Date last updated
21/02/2023

Titles & IDs
Public title
HMPL-760 Safety and Tolerability Study in Patients With Previously Treated CLL/SLL or NHL
Scientific title
A Multicenter, Open-label, Phase 1 Study Evaluating the Safety and Tolerability of HMPL-760 in Patients With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Other Non-Hodgkin Lymphoma (NHL)
Secondary ID [1] 0 0
2021-760-GLOB1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
CLL/SLL 0 0
NHL 0 0
MCL 0 0
MZL 0 0
Lymphoplasmacytic Lymphoma 0 0
Waldenstrom Macroglobulinemia 0 0
Follicular Lymphoma 0 0
DLBCL 0 0
Richter Syndrome 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - HMPL-760

Experimental: Treatment - All patients to receive HMPL-760 daily.


Treatment: Drugs: HMPL-760
Administered orally QD for 28-day cycles
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of DLTs
Timepoint [1] 0 0
Up to 28 days after first dose of study drug
Primary outcome [2] 0 0
Incidence of AEs/SAEs
Timepoint [2] 0 0
From 1st dose to within 30 days of last dose
Primary outcome [3] 0 0
MTD
Timepoint [3] 0 0
From 1st dose to within 30 days of last dose
Primary outcome [4] 0 0
RP2D
Timepoint [4] 0 0
From 1st dose to within 30 days of last dose
Secondary outcome [1] 0 0
Objective Response Rate (ORR)
Timepoint [1] 0 0
From 1st dose of study drug to the time of progressive disease, assessed up to 36 months
Secondary outcome [2] 0 0
Duration of Response (DoR)
Timepoint [2] 0 0
From first dose of study drug to the time of progressive disease, assessed up to 36 months
Secondary outcome [3] 0 0
Clinical Benefit Rate (CBR)
Timepoint [3] 0 0
From 1st dose of study drug to the time of progressive disease, assessed up to 36 months
Secondary outcome [4] 0 0
Progression-free Survival (PFS)
Timepoint [4] 0 0
From 1st dose of study drug to the time of progressive disease, assessed up to 36 months
Secondary outcome [5] 0 0
Maximum Plasma Concentration [Cmax]
Timepoint [5] 0 0
From 1st dose to within 30 days of last dose
Secondary outcome [6] 0 0
Chemokines
Timepoint [6] 0 0
From 1st dose to within 30 days of last dose
Secondary outcome [7] 0 0
Phospho-BTK
Timepoint [7] 0 0
From 1st dose to within 30 days of last dose

Eligibility
Key inclusion criteria
* ECOG performance status of 0 or 1;
* Histologically confirmed NHL or CLL with disease progression or intolerance to either =2 prior regimens. Patients with CLL/SLL and indolent NHL must meet criteria for systemic therapy. Patients with gastric extranodal MZL who are H. pylori positive must have failed H. pylori eradication therapy.
* Availability of tumor sample: This may be an archival tissue sample obtained after most recent therapy or a fresh biopsy; if tumor sample is not available for patients in dose escalation, the Sponsor may waive the requirement after discussion.
* Dose expansion stage only: Patients must have been treated with 1 prior regimen containing a BTK inhibitor in cohorts 1 to 5;
* Expected survival of more than 24 weeks as determined by the Investigator.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients with primary central nervous system lymphoma.
* Any of the following laboratory abnormalities:

* Absolute neutrophil count (ANC) <0.75×109/L
* Hemoglobin <8 mg/L
* Platelets <50×109/L
* Note: In the dose expansion stage, patients with cell counts below the thresholds listed above may be considered eligible if there is documented bone marrow infiltration and Sponsor approval
* Inadequate organ function
* International normalized ratio (INR) >1.5×ULN, activated partial thromboplastin time (aPTT) >1.5×ULN

- Patients requiring anticoagulation therapy (except vitamin K antagonists [ie, warfarin]) but with a stable INR within the recommended range according to the local guideline are eligible.
* Patients with presence of second primary malignant tumors within the last 2 years, with the exception of the following:

* Basal cell carcinoma of the skin
* Squamous cell carcinoma of the skin
* Carcinoma in situ of the cervix
* Carcinoma in situ of the breast
* Clinically significant history of liver disease, including cirrhosis or current known active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or cytomegalovirus (CMV).
* Cancer therapy, including chemotherapy, hormonal therapy, biologic therapy, vaccine, or radiotherapy within 3 weeks prior to initiation of study treatment. For oral targeted therapies, a washout period of 5 half-lives of the agent (minimum 3 days) prior to the initiation of study treatment can be used.
* Any granulocyte colony-stimulating factor treatment/blood transfusion within 7 days before the screening hematology test.
* Prior use of any drug that is a strong inducer or inhibitor of CYP3A4 within 2 weeks prior to initiation of study treatment.
* Prior use of proton pump inhibitors (PPIs) within 5 days of study treatment
* Any transplant within 100 days prior to initiation of study treatment
* Clinically significant active infection or with an unexplained fever.
* Treatment within a clinical study of an investigational agent or using an investigational device within 3 weeks prior to initiation of the current study treatment.
* AEs from prior antineoplastic therapy that have not resolved to grade <1
* Pregnant (positive urine or serum beta human chorionic gonadotropin test) or lactating women.
* New Your Heart Association (NYHA) class II or greater congestive heart failure.

NOTE: Only key inclusion/exclusion criteria are listed. Full details are in the protocol.

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/02/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/11/2022
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Louisiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Maryland
Country [5] 0 0
United States of America
State/province [5] 0 0
Missouri
Country [6] 0 0
United States of America
State/province [6] 0 0
New Jersey
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
France
State/province [9] 0 0
Alpes Maritimes
Country [10] 0 0
France
State/province [10] 0 0
Paris
Country [11] 0 0
France
State/province [11] 0 0
Val De Marne
Country [12] 0 0
France
State/province [12] 0 0
Vienne
Country [13] 0 0
Israel
State/province [13] 0 0
Jerusalem
Country [14] 0 0
Israel
State/province [14] 0 0
Petach-Tikva
Country [15] 0 0
Israel
State/province [15] 0 0
Ramat Gan
Country [16] 0 0
Israel
State/province [16] 0 0
Tel Aviv
Country [17] 0 0
Italy
State/province [17] 0 0
Roma
Country [18] 0 0
Italy
State/province [18] 0 0
Torino
Country [19] 0 0
Italy
State/province [19] 0 0
Bologna
Country [20] 0 0
Italy
State/province [20] 0 0
Milano
Country [21] 0 0
Poland
State/province [21] 0 0
Katowice
Country [22] 0 0
Poland
State/province [22] 0 0
Legnica
Country [23] 0 0
Poland
State/province [23] 0 0
Skórzewo
Country [24] 0 0
Poland
State/province [24] 0 0
Torun
Country [25] 0 0
Spain
State/province [25] 0 0
Barcelona
Country [26] 0 0
Spain
State/province [26] 0 0
Madrid
Country [27] 0 0
Spain
State/province [27] 0 0
Sevilla

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hutchmed
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Vijay Jayaprakash, MBBS, PHD
Address 0 0
Hutchison Medipharma Limited
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05176691