Recombinant Humanized Anti-CD47 / PD-1 Bifunctional Antibody HX009 Injection in the Treatment of Advanced Solid Tumors

NCT04886271 | Completed Phase 2 DMC

• 1 other identifier: HX009-II-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multi-center phase II clinical trial to evaluate the anti-tumor activity and safety of HX009 in subjects with advanced solid tumors.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR) of patients with solid tumors treated with HX009 assessed by the Independent Review Committee (IRC)

  The ORR is defined as the percentage of participants in the analysis population who had a confirmed Complete Response or Partial Response using RECIST 1.1 criteria.

  Approximately 1 year

Secondary Outcomes (14)

• Objective response rate(ORR) of patients with solid tumors treated with HX009 per Investigator Assessment

  Approximately 1 year

• Duration of response (DoR) of patients with solid tumors treated with HX009

  Approximately 1 year

• Disease control rate (DCR) of patients with solid tumors treated with HX009

  Approximately 1 year

• Progression-free survival (PFS) of patients with solid tumors treated with HX009

  Approximately 1 year

• Overall survival (OS) of patients with solid tumors treated with HX009

  Approximately 1 year

Study Arms (1)

HX009

EXPERIMENTAL

Drug: HX009

Interventions

HX009 DRUG

Eligible participants will receive HX009 treatment at 5mg/Kg via IV infusion over 60-120 minutes, and the scheduled dosing cycle is once every 2 weeks.

HX009

Eligibility Criteria

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

You may qualify if:

• Male or female, aged 18 to 75 years, inclusive;
• Eastern Cooperative Oncology Group performance status of 0 to 1;
• Having unresectable locally advanced or metastatic solid tumor (confirmed by histology and cytology);
• Participants must have failed the standard treatment (due to either disease progression or intolerable toxicity) or the standard of care had not been established for the specific condition;
• Measurable extracranial lesion based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1;
• Life expectancy ≥12 weeks;
• For prior anti-tumor therapies, the following conditions must be met:
• The interval between local radiotherapy or radiotherapy for bone metastasis and the first dose is ≥2 weeks;
• The interval between the last dose of previous chemotherapy, immunotherapy (including PD-1, PD-L1 or CTLA-4 antibodies), biological therapy (tumor vaccines, cytokines, or anti-cancer growth factors) and the first dose of HX009 is ≥4 weeks (The interval between the last dose of small molecule targeted drugs and the first dose of HX009 is ≥2 weeks);
• The interval between the last dose of anti-cancer Traditional Chinese Medicine and the first dose of HX009 is ≥ 2 weeks;
• Has had previously serious adverse reactions (pneumonia or myocarditis) related to previous PD1/PDL1or CTLA-4 inhibitors that preclude their treatment according to the investigator's criteria;mmune-related adverse reactions must be restored to Grade 1 except for adverse endocrine system reactions;
• Participants with asymptomatic central nervous system (CNS) metastases are eligible only if they have no evidence of progression by imaging for at least 12 weeks prior to the first dose of HX009 and are not using corticosteroids;
• Appropriate organ functions according to the following laboratory tests :
• Absolute neutrophil count (ANC)≥1.5 × 10\^9/L
• Absolute white blood cell count (WBC) ≥3.0×10\^9/L

You may not qualify if:

• Participants having a known additional malignancy within 5 years before enrollment, except for malignancies with low risk of metastasis and death (5-year survival rate\> 90%), such as completely resected basal cell or squamous cell skin cancer, or cervical carcinoma in situ, or superficial bladder cancer,early breast cancer with low risk of recurrence, etc;
• Adverse reactions related to previous treatment that failed to recover to CTCAE 5.0 ≤ grade 1 (chemotherapy-induced alopecia or grade 2-3 peripheral neurotoxicity are eligible; immune-related grade 2-3 hypothyroidism is eligible)；
• Participants with active or history of autoimmune diseases are ineligible, except for the following conditions:
• Participants with type 1 diabetes who are in stable condition after using a fixed dose of insulin;
• Autoimmune hypothyroidism requiring only hormone replacement therapy;
• Autoimmune skin diseases that do not require systemic treatment (such as eczema, skin rashes that account for less than 10% of the body surface, or psoriasis without ophthalmological symptoms);
• Participants expected to undergo major surgery within 28 days before the planned first dose of HX009;
• Participants receiving systemic corticosteroids equivalent to \>10 mg prednisone/day or other immunosuppressive drugs within 14 days before the first administration of HX009, except for the following conditions:
• Participants using topical or inhaled corticosteroids;
• Short-term (≤7 days) use of glucocorticoids equivalent to ≤10 mg of prednisone daily for the prevention or treatment of non-autoimmune allergic diseases is permitted;
• Participants with known interstitial lung disease or non-infectious pneumonia requiring systemic treatment with glucocorticoids;
• Participants having clinically serious cardiovascular diseases (unstable angina or myocardial infarction within 6 months before enrollment), diabetes, or hypertension;
• Participants having a history of human immunodeficiency virus infection, or having other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation;
• Patients with active chronic hepatitis B or active hepatitis C. Hepatitis B virus carriers, stable hepatitis B after drug treatment (DNA titer not higher than 500 IU/mL or copy number \<1000 copies/ml) and cured hepatitis C patients (HCV RNA test negative) can be enrolled;
• Participants having a serious infection within 4 weeks before the first administration of HX009, or having an active infection that require oral or intravenous antibiotic treatment;

Sponsors & Collaborators

• Hangzhou Hanx Biopharmaceuticals, Ltd.: lead

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center

Shenzhen, Guangdong, China

Location

Study Officials

• Jing Huang, MD

  Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 14, 2021
• Study Start: May 12, 2021
• Primary Completion: January 12, 2024
• Study Completion: February 22, 2024
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

CN (1)