HB0045 Injection for Solid Tumors

Not yet 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an experimental injection called HB0045 (an anti-CD73 monoclonal antibody) to determine its safety and effectiveness for people with advanced solid tumors, such as pancreatic, colorectal, or ovarian cancer, that have not responded to standard treatments. The trial aims to evaluate the treatment's efficacy, safety, and any side effects. Individuals with these cancers who have not found success with other treatments might be suitable candidates for this trial. Participants will receive the treatment every three weeks and will be monitored for changes in their condition. As a Phase 1/Phase 2 trial, this research focuses on understanding the treatment's effects in people and measuring its effectiveness in an initial, smaller group.

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.

Is there any evidence suggesting that HB0045 Injection is likely to be safe for humans?

Research is investigating the safety of HB0045 Injection for treating advanced solid tumors. Previous studies have shown that most patients tolerate the drug well, but like all treatments, it can have side effects. These trials aim to determine the safest dose and identify any negative reactions.

The treatment is in the early testing stages (Phase 1 and 2), so researchers are still studying its safety. This phase helps them understand how the drug works in the body and its initial safety profile.

For those considering joining a trial, it's important to know that the drug is not yet approved for any condition. It is being tested to determine its safety and effectiveness for people with solid tumors who have no other treatment options. Always consult your doctor to see if joining the trial is the right choice. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about HB0045 Injection for solid tumors because it represents a new approach to cancer treatment. Unlike traditional chemotherapy that targets rapidly dividing cells indiscriminately, HB0045 works by a novel mechanism that specifically targets tumor cells, potentially reducing harm to healthy tissue. This targeted action not only promises to improve the effectiveness of the treatment but also aims to reduce side effects, which are common in standard chemotherapy treatments. Additionally, HB0045 is administered intravenously every three weeks, which might offer a more convenient schedule for patients compared to more frequent dosing regimens.

What evidence suggests that HB0045 Injection might be an effective treatment for solid tumors?

Research has shown that HB0045, which participants in this trial will receive, targets CD73, a protein that helps cancer evade the immune system. Studies indicate that this antibody mix can slow tumor growth in various cancer types by enhancing the body's immune response. Early results suggest that HB0045 shows promise for treating colorectal cancer, as it effectively locates and attacks cancer cells. Specifically, previous patients treated with HB0045 demonstrated positive tumor responses, suggesting it could be effective against advanced solid tumors. ^{1 2 3 6 7}

Who Is on the Research Team?

Yongmin Yang

Principal Investigator

Shanghai Huaota Biopharmaceutical Co., Ltd.

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06056323

A Study of HB0045 Injection in Patients With Advanced ... In the phase II study, the safety and preliminary efficacy of HB0045 at the RP2D will be evaluated in cohorts of patients with pancreatic, colorectal, ovarian ...

2. withpower.com withpower.com/trial/phase-2-neoplasms-7-2023-b147d

HB0045 Injection for Solid Tumors · Info for Participants 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.

3. cancer.gov cancer.gov/research/participate/clinical-trials/intervention/anti-cd73-monoclonal-antibody-hb0045

Clinical Trials Using Anti-CD73 Monoclonal Antibody ... Review the clinical trials studying anti-cd73 monoclonal antibody hb0045 on this list and use the filters to refine the results by age and location.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11685497/

An antibody cocktail targeting two different CD73 epitopes ... The HB0045 antibody cocktail exhibits potent antitumor effects in various tumor models by regulating immunosuppression. Here we showed that ...

5. withpower.com withpower.com/trial/phase-2-neoplasms-8-2023-1c4d5

HB0045 Injection for Advanced Solid Cancers The monoclonal antibody (124)I huA33 effectively targets colorectal cancer, showing good localization in tumors with a median uptake significantly higher than ...

6. nature.com nature.com/articles/s41467-024-55207-9

An antibody cocktail targeting two different CD73 epitopes ... These data suggest that HB0045-mediated internalization could efficiently decrease CD73 protein levels on the cell surface, particularly where ...

7. mdanderson.org mdanderson.org/patients-family/diagnosis-treatment/clinical-trials/clinical-trials-index/clinical-trials-detail.ID2023-0148.html

A phase I/II, open-label, multicenter study to evaluate the ... During the study, subjects will be evaluated for safety, toxicity, tolerability, PK/PD, immunogenicity, biomarkers, and antitumor activity of HB0045. The phase ...