HB0025 Injection for Cancer

Not currently recruiting at 5 trial locations

Overseen By Anthony Tolcher, M.D

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Huabo Biopharm Co., Ltd.

Must be taking: Suppressive therapy

Must not be taking: Corticosteroids, Immunosuppressive agents

Disqualifiers: CNS metastases, Autoimmune disease, Cardiovascular events, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called HB0025 (an injection) for individuals with advanced solid tumors, such as liver, lung, or kidney cancer, that have not responded to other treatments. The main goal is to determine if HB0025 is safe and effective against these cancers. Suitable candidates are those with advanced cancer that has worsened despite other treatments and cannot be cured with surgery. As a Phase 1 trial, this research aims to understand how HB0025 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that certain medications, like systemic corticosteroids above a specific dose, should not be used shortly before the trial. It's best to discuss your current medications with the trial team to get specific guidance.

Is there any evidence suggesting that HB0025 is likely to be safe for humans?

Research has shown that HB0025 has generally been well-tolerated in past studies. In earlier research, HB0025 was tested with chemotherapy and found to be safe, as most participants did not experience serious side effects. Another study examined HB0025 alone and with other treatments, finding few severe side effects, which suggests it is fairly safe for humans.

It is important to note that the current trial is in a very early stage. Researchers are primarily focused on understanding the treatment's safety and potential side effects. While earlier studies are promising, this trial will help confirm how well HB0025 is tolerated. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about HB0025 because it offers a fresh approach to cancer treatment. Unlike standard chemotherapy options that target rapidly dividing cells, HB0025 works by targeting specific cancer cell pathways, potentially reducing harm to healthy cells. Another standout feature is its delivery method—administered intravenously every two weeks, it could offer a more convenient schedule compared to daily oral medications. These unique aspects of HB0025 hold promise for not only improving effectiveness but also minimizing side effects, making it a potentially game-changing option for cancer patients.

What evidence suggests that HB0025 might be an effective treatment for cancer?

Research has shown that HB0025, the investigational treatment in this trial, has promising effects against tumors, particularly in patients with advanced cancers who have already undergone many treatments. In earlier studies, HB0025 combined with chemotherapy demonstrated strong cancer-fighting abilities and was generally safe. This treatment targets two proteins, PD-L1 and VEGF, which aid tumor growth and spread. Early research suggests that HB0025 might be more effective than treatments targeting only one of these proteins. This offers hope that HB0025 could be a good option for people with difficult-to-treat cancers. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors that have worsened after standard treatments or when no further beneficial treatment options are available. Participants must be over 18, have a life expectancy of at least 3 months, and good liver function. They should not have severe autoimmune diseases, recent heart attacks or strokes, active infections including COVID-19, or be pregnant.

Inclusion Criteria

Coagulation: International Normalized Ratio (INR)≤1.6.

You understand the study and agree to follow all the rules by signing a document.

I have advanced kidney or endometrial cancer not suitable for surgery or has spread.

Exclusion Criteria

Women of childbearing potential who do not consent to use acceptable methods of birth control during treatment and for an additional 90 days after the last administration of HB0025.

I have had severe side effects from previous immune treatments that made me stop the treatment.

My diabetes is not under control, with an A1c over 8%.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of HB0025 to determine the maximum tolerated dose (MTD) or optimal biological dose (OBD)

Approximately 8 months

Bi-weekly visits for dose administration and monitoring

Dose Expansion

Participants receive the recommended phase 2 dose (RP2D) to further evaluate safety and efficacy

Up to 24 months

Bi-weekly visits for dose administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 24 months

What Are the Treatments Tested in This Trial?

Interventions

• HB0025

Trial Overview

HB0025 is being tested in patients with various types of advanced solid tumors to assess its safety and effectiveness. The study involves multiple centers and includes dose escalation (finding the right dose) and expansion (testing it on more people). Patients will receive HB0025 injections every 28 days while researchers monitor their response to the drug.

How Is the Trial Designed?

Group I: HB0025 Experimental Treatment 1 Intervention

HB0025 IV every 2 weeks (q2w)

Who Is Running the Clinical Trial?

Huabo Biopharm Co., Ltd.

Lead Sponsor

Trials

14

Recruited

1,600+

Published Research Related to This Trial

AZD6738 (ceralasertib) is a selective ATR kinase inhibitor that shows promise in treating cancer by modulating DNA damage response pathways, particularly in cells with defects in the ATM pathway or those experiencing replication stress.

In preclinical models, AZD6738 demonstrated significant antitumor activity, especially when combined with chemotherapy agents like carboplatin and irinotecan, achieving complete tumor regression in certain breast cancer models, suggesting its potential for clinical evaluation as both a monotherapy and in combination therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ATR Inhibitor AZD6738 (Ceralasertib) Exerts Antitumor Activity as a Monotherapy and in Combination with Chemotherapy and the PARP Inhibitor Olaparib. Wilson, Z., Odedra, R., Wallez, Y., et al.[2023]

The combination of olaparib and eribulin was found to be effective in treating advanced or metastatic triple-negative breast cancer (TNBC), with a response rate of 29.2% among 24 patients in the phase II trial.

While the treatment showed antitumor activity, it also resulted in significant adverse effects, including high rates of neutropenia and leucopenia, indicating that careful monitoring is necessary, especially for febrile neutropenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase I/II trial of olaparib tablet in combination with eribulin in Japanese patients with advanced or metastatic triple-negative breast cancer previously treated with anthracyclines and taxanes. Yonemori, K., Shimomura, A., Yasojima, H., et al.[2020]

Citations

1.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.5602

A phase II efficacy and safety study of HB0025 (a PD-L1 ...

Conclusions: HB0025 in combination with chemotherapy demonstrated promising anti-tumor efficacy with good safety profile. Regardless MMR status, ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06758557

A Study to Evaluate the Safety and Efficacy of HB0025 ...

This study is a multicenter, two-tumor, multi-cohort, dose-escalation and dose-expansion Phase Ib/II clinical trial of HB0025 combined with chemotherapy, ...

3.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.e14600

Phase I summary of the HB0025 efficacy and safety to ...

HB0025 monotherapy showed an acceptable safety profile and promising anti-tumor activity for prior heavily treated NSCLC.

4.

clin.larvol.com

clin.larvol.com/trial-detail/NCT06758557

A Study to Evaluate the Safety and Efficacy of HB0025 ...

A phase II efficacy and safety study of HB0025 (a PD-L1/VEGF bispecific antibody) in combination with chemotherapy as first-line treatment for advanced or ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8678608/

A Novel Bispecific Antibody Targeting PD-L1 and VEGF ...

Preclinical data demonstrated that HB0025 was more effective in inhibiting cancer growth than anti PD-L1 mAb or VEGFR1D2 fusion protein.

6.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.2589

Safety and efficacy of HB0025, an anti-PD-1/VEGF ...

Here, we present preliminary safety and efficacy data from a dose escalation phase I study of HB0025. Methods: Eligible patients(pts) were ...

7.

asco.org

asco.org/abstracts-presentations/ABSTRACT492890

A phase II efficacy and safety study of HB0025 (a PD-L1/ ...

ASCO Members: Tell Us How The Government Shutdown Is Impacting You. ASCO Logo · Search · Abstracts · Guidelines · Journal Articles.

8.

ovid.com

ovid.com/journals/jclon/abstract/10.1200/jco.2024.42.16_suppl.e14600~phase-i-summary-of-the-hb0025-efficacy-and-safety-to-the

Phase I summary of the HB0025 efficacy and safety...

Phase I summary of the HB0025 efficacy and safety to the heavily pretreated non-small cell lung cancer (NSCLC) population. Du, Yiqun; Liu ...