HB0045 Injection for Solid Tumors

Recruiting at 2 trial locations

Overseen By Nashat Gabrail, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Huabo Biopharm Co., Ltd.

Must not be taking: Corticosteroids, Immunosuppressants, Antibiotics, others

Disqualifiers: CNS metastases, Heart failure, Autoimmune disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

71 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests HB0045, a new cancer drug, on patients with advanced solid tumors who have no other treatment options. The study aims to find the safest and most effective dose by giving the drug in gradually higher amounts and monitoring for side effects and tumor response.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that anticancer therapy should not be taken less than 4 weeks before the study starts, and certain medications like systemic corticosteroids and antibiotics have specific restrictions. It's best to discuss your current medications with the trial team.

What data supports the effectiveness of the HB0045 Injection drug for solid tumors?

Research shows that blocking CD73, a protein that helps tumors grow by weakening the immune system, can improve cancer treatment. Studies suggest that combining anti-CD73 drugs with other cancer therapies can enhance their effectiveness in fighting tumors. ^{1 2 3 4 5}

How is the drug HB0045 Injection different from other treatments for solid tumors?

HB0045 Injection is unique because it is an anti-CD73 monoclonal antibody, which targets a specific protein on tumor cells to help the immune system attack the cancer. This mechanism is different from traditional chemotherapy, which generally targets rapidly dividing cells without such specificity. ^{6 7 8 9 10}

Research Team

Yongmin Yang

Principal Investigator

Shanghai Huaota Biopharmaceutical Co., Ltd.

Eligibility Criteria

Adults (≥18 years) with advanced solid tumors like pancreatic, colorectal, or ovarian cancer that have worsened despite standard treatments. They must be physically capable of participating (ECOG 0-1), have measurable tumor lesions, and a life expectancy over 12 weeks. Participants need functioning major organs and no recent surgeries or ileus. Those with controlled hepatitis B/C or HIV may join. Women must test negative for pregnancy and use effective birth control.

Inclusion Criteria

My cancer has worsened after one treatment, but the study drug may help.

I am a woman who can have children, tested negative for pregnancy, and will use birth control.

My organs are working well enough for treatment.

Exclusion Criteria

I haven't needed systemic therapy for an autoimmune disease in the last 2 years.

I have not had another type of cancer in the last 5 years.

My cancer has spread to my brain or spinal cord.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I Treatment

Participants receive HB0045 as a monotherapy at escalating doses to evaluate safety and tolerability

Up to 3 months

Every 3 weeks

Phase II Treatment

Evaluation of safety and preliminary efficacy of HB0045 at the RP2D in cohorts of patients with specific cancers

Up to 24 months

Every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 24 months

Treatment Details

Interventions

• HB0045 Injection

Trial Overview The trial is testing HB0045 Injection's safety and effectiveness in treating advanced solid tumors. It's an early-stage study (phase I/II) where patients receive the drug over cycles lasting 21 days each to assess how well it works against their cancer and what side effects occur.

Participant Groups

Group I: HB0045 Experimental Treatment 1 Intervention

HB0045 IV every 3 weeks (q3w)

Who Is Running the Clinical Trial?

Huabo Biopharm Co., Ltd.

Lead Sponsor

Trials

14

Recruited

1,600+

Dana-Farber Cancer Institute

Collaborator

Trials

1,128

Recruited

382,000+

Gabrail Cancer Center Research

Collaborator

Trials

3

Recruited

160+

M.D. Anderson Cancer Center

Collaborator

Trials

3,107

Recruited

1,813,000+

Findings from Research

CD73 is significantly overexpressed in colorectal cancer (CRC) tissues compared to normal tissues, with high expression found in approximately 44.8% to 50.4% of patients in two independent cohorts.

High levels of CD73 are associated with poorer overall survival rates and serve as an independent prognostic biomarker for CRC, indicating its potential role in predicting patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High expression of CD73 as a poor prognostic biomarker in human colorectal cancer. Wu, XR., He, XS., Chen, YF., et al.[2022]

AB680 is a potent human CD73 inhibitor currently undergoing a Phase I clinical trial for solid tumors, demonstrating a promising approach in cancer treatment.

The drug acts as a reversible, slow-onset competitive inhibitor of CD73, with a very low inhibition constant (Ki) of 5 pM, indicating its strong binding affinity and potential effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Exceptionally Potent Inhibitor of Human CD73. Bowman, CE., da Silva, RG., Pham, A., et al.[2020]

In a study of 198 breast cancer patients, CD73 was found to be expressed in 25.4% of all breast cancer cases, with a higher expression rate of 30.9% in invasive breast cancer, indicating its potential role in tumor progression.

CD73 expression was linked to more advanced disease characteristics, such as higher T-stage and node metastasis, but did not significantly affect disease-free survival or overall survival rates, suggesting it could serve as a prognostic marker and a target for therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expression of CD73 is associated with tumor progression and intratumoral inflammation in breast cancer. Choi, HR., Oh, HK., Park, SH., et al.[2022]

CD73 is an important immune checkpoint that helps tumors grow by weakening the immune response and encouraging blood vessel formation, making it a key target for cancer treatment.

Combining CD73 inhibitors with other therapies, like immune checkpoint blockers, has shown enhanced antitumor effects in preclinical studies and promising results in patients with advanced solid tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CD73: an emerging checkpoint for cancer immunotherapy. Chen, S., Wainwright, DA., Wu, JD., et al.[2023]

The chimeric antibody B72.3-1-3 retains specific binding to LS174T tumor cells and shows similar biodistribution patterns to the native murine antibody B72.3, indicating it can effectively target tumors.

B72.3-1-3 significantly enhances the ability of human lymphocytes to kill LS174T tumor cells, suggesting that chimerization may improve therapeutic efficacy while potentially reducing immune responses against murine antibodies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative biodistribution and antibody-dependent cellular cytotoxicity of native and heavy chain chimeric antibody. Gallinger, S., Papa, MZ., Reilly, RM., et al.[2016]

References

1. United States pubmed.ncbi.nlm.nih.gov

High expression of CD73 as a poor prognostic biomarker in human colorectal cancer. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

An Exceptionally Potent Inhibitor of Human CD73. [2020]

3. Australia pubmed.ncbi.nlm.nih.gov

Expression of CD73 is associated with tumor progression and intratumoral inflammation in breast cancer. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Identification of CD73 as a Novel Biomarker Encompassing the Tumor Microenvironment, Prognosis, and Therapeutic Responses in Various Cancers. [2022]

5. England pubmed.ncbi.nlm.nih.gov

CD73: an emerging checkpoint for cancer immunotherapy. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Comparative biodistribution and antibody-dependent cellular cytotoxicity of native and heavy chain chimeric antibody. [2016]

7. United States pubmed.ncbi.nlm.nih.gov

Detection of lung cancer in clinical specimens using a human monoclonal antibody HB4C5-clone 3. [2015]

8. United States pubmed.ncbi.nlm.nih.gov

Radioimmunoscintigraphy of colon cancer with iodine-131-labeled B72.3 monoclonal antibody. [2016]

9. United States pubmed.ncbi.nlm.nih.gov

Regional and systemic distribution of anti-tumor x anti-CD3 heteroaggregate antibodies and cultured human peripheral blood lymphocytes in a human colon cancer xenograft. [2017]

10. United States pubmed.ncbi.nlm.nih.gov

Prolonged binding of a radiolabeled monoclonal antibody (B72.3) used for the in situ radioimmunodetection of human colon carcinoma xenografts. [2016]