Overview

A Phase I Clinical Study of HMPL-A83 in Patients With Advanced Malignant Neoplasm

Status:
Not yet recruiting
Trial end date:
2025-09-01
Target enrollment:
0
Participant gender:
All
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 advanced malignant neoplasm.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hutchison Medipharma Limited
Criteria
Inclusion Criteria:

1. Solid tumors/lymphomas/AML/MDS with confirmed per study protocol;

2. Is willing and able to provide informed consent;

3. Aged 18-75 years (inclusive);

4. Life expectancy ≥12 weeks as judged by the investigator;

5. 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 Criteria:

1. Previous exposure to any agent targeting the CD47/SIRP alpha axis.

2. 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.

3. 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).

4. 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);

5. Those expected to require other systemic anti-tumor therapies such as chemotherapy,
immunotherapy, biotherapy, or hormonal therapy (except palliative radiotherapy) during
the study.

6. Those who have received prior immunotherapy such as anti-PD- (L) 1 antibody and
discontinued due to ≥ Grade 3 irAEs.

7. Those with known hereditary or acquired bleeding disorder; uncontrolled active
bleeding, coagulopathy; prior history of chronic haemolytic anaemia or positive
hemolysis test at screening.

8. 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.

9. Those have received immunosuppressive drugs within 4 weeks prior to the first dose of
study drug

10. Those requiring long-term systemic hormonal therapy or any other immunosuppressive
medication (excluding inhaled corticosteroid therapy or treatment at equivalent
physiological doses).

11. 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).

12. 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.