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

NCT05429008 | Completed Phase 1

• 1 other identifier: 2021-A83-00CH1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 4

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 advanced malignant neoplasm.

Conditions

Advanced Tumors

Keywords

CD47, HMPL-A83

Outcome Measures

Primary Outcomes (2)

• safety information/AE,SAE

  To evaluate the safety and tolerability of HMPL-A83 in patients with advanced tumors

  up to 3 years

• MTD and RP2D

  To determine the maximum tolerated dose (MTD) and/or the recommended phase II dose (RP2D) of HMPL-A83 in patients with advanced tumors.

  up to 2 years

Secondary Outcomes (2)

• PK endpoints

  up to 3 years

• Efficacy endpoints

  up to 3 years

Study Arms (1)

HMPL-A83

OTHER

Drug: HMPL-A83 The starting dose of HMPL-A83 is 0.3 mg/kg IV QW with escalating dose levels of 1, 3, 10, 20, and 30 mg/kg IV QW, in 28-day treatment cycles. During the study, the below dose had also been selected: 10,20, and 30 mg/kg Q2W in 28-day treatment cycles; 30 and 45mg/kg Q3W.

Drug: HMPL-A83 injection

Interventions

HMPL-A83 injection DRUG

Day 1,8,15,22 dose; 28 day treatment cycles.

Also known as: HMPL-A83

HMPL-A83

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hutchmed: lead

Study Sites (4)

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Location

Shandong Cancer Hospital

Shandong, Jinan, China

Location

Shanghai Orient Hospital

Shanghai, Shanghai Municipality, China

Location

Study Officials

• Ye Guo

  Shanghai East Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: June 23, 2022
• Study Start: July 15, 2022
• Primary Completion: April 7, 2025
• Study Completion: April 7, 2025
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)