Status:
COMPLETED
A Phase I Clinical Study of HMPL-A83 in Patients With Advanced Malignant Neoplasm
Lead Sponsor:
Hutchmed
Conditions:
Advanced Tumors
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This is an open-label, first-in-human (FIH) Phase I study to evaluate the safety, tolerability, and preliminary efficacy of a humanized anti-CD47 monoclonal antibody (HMPL-A83) in patients with advanc...
Detailed Description
This is an open-label, first-in-human (FIH) Phase I study to evaluate the safety, tolerability, and preliminary efficacy of a humanized anti-CD47 monoclonal antibody (HMPL-A83) in patients with advanc...
Eligibility Criteria
Inclusion
- Solid tumors/lymphomas/AML/MDS with confirmed per study protocol;
- Is willing and able to provide informed consent;
- Aged 18-75 years (inclusive);
- Life expectancy ≥12 weeks as judged by the investigator;
- Female patients of childbearing potential and male patients with partners of childbearing potential agree to use a highly effective form(s) of contraception per study protocol.
Exclusion
- Previous exposure to any agent targeting the CD47/SIRP alpha axis.
- Those concurrently participating in another interventional clinical study, excluding those concurrently participating in an observational (non-interventional) clinical study, or in the survival follow-up phase of an interventional study.
- Those have received any investigational drug within 4 weeks prior to the first dose of study drug (note: investigational drug refers to the drug that has not been approved for marketing in China).
- Those with prior anti-tumor therapy-induced toxicity (excluding alopecia or fatigue) not recovered to Grade 0 or 1 as defined by NCI CTCAE v5.0, including immune-related adverse events (irAEs) that have not recovered following immunotherapy, prior to the first dose of study treatment (≥ 4 weeks);
- Those expected to require other systemic anti-tumor therapies such as chemotherapy, immunotherapy, biotherapy, or hormonal therapy (except palliative radiotherapy) during the study.
- Those who have received prior immunotherapy such as anti-PD- (L) 1 antibody and discontinued due to ≥ Grade 3 irAEs.
- Those with known hereditary or acquired bleeding disorder; uncontrolled active bleeding, coagulopathy; prior history of chronic haemolytic anaemia or positive hemolysis test at screening.
- Patients with a history of deep venous thrombosis, pulmonary embolism, or any other serious thromboembolism within two years prior to enrollment, or those currently requiring anticoagulant or thrombolytic therapy as a therapeutic use.
- Those have received immunosuppressive drugs within 4 weeks prior to the first dose of study drug
- Those requiring long-term systemic hormonal therapy or any other immunosuppressive medication (excluding inhaled corticosteroid therapy or treatment at equivalent physiological doses).
- Those have received live attenuated vaccines within 4 weeks prior to the first dose of study drug or planned to receive live attenuated vaccines during the study (for solid tumors)/any type of vaccine (for lymphoma, AML, MDS).
- Those who have received any major surgical operation or uncured wound, ulcer or bone fracture within 4 weeks prior to the first dose of study drug.
Key Trial Info
Start Date :
July 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 7 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05429008
Start Date
July 15 2022
End Date
April 7 2025
Last Update
June 18 2025
Active Locations (4)
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1
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
2
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
3
Shandong Cancer Hospital
Shandong, Jinan, China
4
Shanghai Orient Hospital
Shanghai, Shanghai Municipality, China