HB0036 for Advanced Cancer

Recruiting at 3 trial locations

Overseen By Yang Zheng, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd.

Must not be taking: Antibiotics, Corticosteroids

Disqualifiers: Active CNS metastases, Autoimmune disease, Active infection, others

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

Compensation: Varies

Number of Visits: 2

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess the safety and effectiveness of HB0036, an experimental treatment, for individuals with advanced solid tumors such as lung cancer, melanoma, or esophageal cancer, who have not benefited from standard treatments. The trial will administer HB0036 through an IV every three weeks to evaluate its efficacy and how the body processes it. Suitable candidates include those with advanced cancer unresponsive to standard therapies and at least one tumor measurable on a scan. As a Phase 1 trial, this research focuses on understanding the treatment's effects in people, offering participants the opportunity to be among the first to receive this new treatment.

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, certain conditions like recent use of antibiotics, corticosteroids, or anticancer therapies may affect eligibility, so it's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that HB0036 is likely to be safe for humans?

Research has shown that HB0036 is generally safe for people with advanced solid tumors. Earlier studies revealed that most patients tolerated the treatment well. These studies did not identify any major safety issues, suggesting it is safe enough for further testing in clinical trials. This information should reassure potential participants about the safety of HB0036. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about HB0036 for advanced cancer because it introduces a novel way of tackling the disease. Unlike traditional chemotherapy, which often attacks rapidly dividing cells indiscriminately, HB0036 is designed to target specific pathways involved in cancer cell growth, potentially leading to fewer side effects. Additionally, the treatment is administered intravenously every three weeks, which might offer convenience and improved compliance compared to more frequent dosing schedules. This unique approach could offer new hope for patients with advanced cancer, providing a more targeted and potentially more effective treatment option.

What evidence suggests that HB0036 might be an effective treatment for advanced cancer?

Research shows that HB0036, the investigational treatment in this trial, has promising results in treating advanced solid tumors. Earlier studies found it to be safe and effective against tumors. Lab tests demonstrated that HB0036 can help control tumor growth and support strong responses against tumors. These findings suggest that HB0036 might effectively manage advanced cancers by targeting mechanisms tumors use to evade the immune system. Ongoing studies continue to explore its potential benefits. ^{1 2 3 4 5}

Who Is on the Research Team?

Yang Yang, MD/PHD

Principal Investigator

Shanghai Huaota Biopharmaceutical Co., Ltd.

Are You a Good Fit for This Trial?

Adults with advanced solid tumors, measurable cancer lesions, good performance status (able to carry out daily activities), and proper organ function can join this trial. They must not be pregnant or breastfeeding and agree to use contraception. Exclusions include recent severe allergic reactions to similar drugs, certain heart conditions within the past 6 months, active infections like HIV or hepatitis B/C, other recent treatments or trials, substance abuse issues.

Inclusion Criteria

I am fully active or can carry out light work.

At least one measurable lesion as per RECIST v. 1.1

My cancer is advanced, recurrent, or has spread to other parts.

Exclusion Criteria

I am not pregnant, breastfeeding, and if able to bear children, I agree to use contraception during the trial.

I agree to use birth control during and for 3 months after treatment.

I have been treated with medication targeting the TIGIT pathway.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I Treatment

Evaluation of safety and tolerability of HB0036 in patients with advanced solid tumors

21 days

1 visit every 3 weeks

Phase II Treatment

Evaluation of safety and efficacy of HB0036 at the RP2D in cohorts of patients with NSCLC and/or other solid tumors

Up to 24 months

1 visit every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• HB0036

Trial Overview The study is testing HB0036's safety and effectiveness in treating advanced solid tumors including non-small cell lung cancer. It's an early-phase trial assessing how the body processes the drug (pharmacokinetics), its impact on the body (pharmacodynamics), and its potential benefits.

How Is the Trial Designed?

Group I: HB0036 Experimental Treatment 1 Intervention

HB0036 IV every 3 weeks (q3w)

Who Is Running the Clinical Trial?

Shanghai Huaota Biopharmaceutical Co., Ltd.

Lead Sponsor

Trials

12

Recruited

810+

Citations

1. researchgate.net researchgate.net/publication/381184622_A_phase_III_open-label_multicenter_study_to_evaluate_the_safety_pharmacokinetics_pharmacodynamics_and_efficacy_of_HB0036_in_patients_with_advanced_solid_tumors

A phase I/II, open-label, multicenter study to evaluate the ... Conclusions: HB0036 showed an acceptable safety profile and promising anti-tumor activity in advanced solid tumors, which supports further studies to explore ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10819708/

Anti-PD-L1-Based Bispecific Antibodies Targeting Co ... In pre-clinical tumor models, HB-0036 substantially improves tumor control and is associated with favorable anti-tumor signatures, including the ...

3. cell.com cell.com/cancer-cell/fulltext/S1535-6108%2824%2900358-1

The hallmarks of cancer immune evasion Here, we review key hallmarks of cancer immune evasion under the “three Cs” framework and discuss promising strategies targeting such immunoevasive mechanisms.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05417321

A Study Evaluating the Safety and Efficacy of HB0036 in ... This is a phase Ⅰ/Ⅱ, multicenter, open-label, first-in-human study in patients with advanced solid tumors. During the phase Ⅰ study, the safety and ...

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.e14504

A phase I/II, open-label, multicenter study to evaluate the ... HB0036 showed an acceptable safety profile and promising anti-tumor activity in advanced solid tumors, which supports further studies.