Testing HMPL-A83 for advanced tumors

A Phase I, Multicenter, Open-label Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HMPL-A83 in Patients With Advanced Malignant Neoplasm

This study is testing a new treatment called HMPL-A83 to see if it is safe and effective for people with advanced tumors.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 99 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Hutchmed (industry)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 3 sites (Nanchang, Jiangxi and 2 other locations)
• Trial ID: NCT05429008 on ClinicalTrials.gov

What this trial studies

This open-label, first-in-human Phase I study evaluates the safety, tolerability, and preliminary efficacy of HMPL-A83, a humanized anti-CD47 monoclonal antibody, in patients with advanced malignant neoplasms. The study will enroll approximately 31-84 patients using a 3 + 3 dose escalation design across six dose groups. Participants will be monitored for dose-limiting toxicities and overall response to the treatment. The goal is to establish a safe dosage and gather initial efficacy data for this novel therapy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with confirmed advanced solid tumors or lymphomas who have not previously been treated with agents targeting the CD47/SIRP alpha axis.

Not a fit: Patients who have previously received treatment targeting the CD47/SIRP alpha axis or those currently participating in another interventional clinical study may not benefit from this trial.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced tumors that currently have limited treatment options.

How similar studies have performed: While this approach is novel in this specific context, similar studies targeting the CD47 pathway have shown promise in other settings.

Eligibility 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.

Where this trial is running

Nanchang, Jiangxi and 2 other locations

• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (RECRUITING)
• Shandong Cancer Hospital — Shandong, Jinan, China (RECRUITING)
• Shanghai Orient Hospital — Shanghai, Shanghai, China (NOT_YET_RECRUITING)

Study contacts

• Principal investigator: Ye Guo — Shanghai East Hospital
• Study coordinator: Haiying Hong, CPM

Conditions: Advanced Tumors, CD47, HMPL-A83