HB0025 Injection for Cancer

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

154 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called HB0025 for patients with advanced solid tumors who have no other treatment options. The study aims to find the safest and most effective dose by adjusting the amount given to patients over time. Researchers will monitor how the drug affects the body and its ability to fight tumors.

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.

What safety data exists for HB0025 Injection for Cancer?

There is no specific safety data available for HB0025 Injection for Cancer in the provided research articles. ^{1 2 3 4 5}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States 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. [2023]

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

PARP Inhibitors for the Treatment and Prevention of Breast Cancer. [2021]

3. England pubmed.ncbi.nlm.nih.gov

A real-world pharmacovigilance study of FDA adverse event reporting system (FAERS) events for niraparib. [2023]

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

Olaparib and Ceralasertib (AZD6738) in Patients with Triple-Negative Advanced Breast Cancer: Results from Cohort E of the plasmaMATCH Trial (CRUK/15/010). [2023]

5. England 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. [2020]