What side effects are associated with this type of intervention?

Common treatments for solid tumors, including chemotherapy, targeted therapy, and immunotherapy, often have a range of side effects. Chemotherapy can cause hematologic toxicity (e.g., neutropenia, anemia), gastrointestinal issues (e.g., nausea, vomiting, diarrhea), and fatigue. Targeted therapies may lead to specific organ toxicities, such as liver or kidney damage, and can also cause skin rashes and hypertension. Immunotherapy, while effective, can result in immune-related adverse events like pneumonitis, colitis, and endocrinopathies. In the context of the HB0045 trial, patients are monitored for safety, toxicity, and tolerability, which suggests a comprehensive assessment of these potential side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for advanced solid tumors, including immune checkpoint inhibitors like pembrolizumab and nivolumab, which target PD-1/PD-L1 pathways to enhance the body's immune response against cancer cells. Additionally, targeted therapies such as bevacizumab, which inhibits angiogenesis, and tyrosine kinase inhibitors like erlotinib and gefitinib, which target specific mutations in cancer cells, have been approved. These treatments have been evaluated for their safety, efficacy, and impact on various biomarkers, similar to the parameters being studied in the HB0045 trial.

What other types of research exist?

Promising novel alternatives for solid tumor patients include: 1) Pembrolizumab (Keytruda) combined with chemotherapy, which has shown efficacy in metastatic non-small-cell lung cancer. 2) Atezolizumab (Tecentriq) combined with bevacizumab and chemotherapy, which has been effective in non-small-cell lung cancer. 3) Cabozantinib (Cometriq), a tyrosine kinase inhibitor, which has shown activity in medullary thyroid cancer and other solid tumors. 4) Avatrombopag, a thrombopoietin receptor agonist, which is being explored for its potential in various cancers. These alternatives have demonstrated antitumor activity and are being evaluated for their safety and tolerability in clinical trials.

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HB0045 Injection for Solid Tumors

Phase 1 & 2

Waitlist Available

Research Sponsored by Huabo Biopharm Co., Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include reactions related to the immune system such as inflammation in different parts of the body, potential toxicity affecting organ function, fatigue, changes in blood counts which could affect infection risk or cause bleeding issues, allergic responses to the injection itself.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase I: Maximum Tolerated Dose(MTD)

Phase I: The incidence of Dose-Limiting Toxicities (DLTs) in patients receiving HB0045

Phase II: Objective response rate (ORR)

Secondary study objectives

Anti-drug antibodies (ADA)

Disease control rate (DCR)

Duration of response (DOR)

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: HB0045Experimental Treatment1 Intervention

HB0045 IV every 3 weeks (q3w)

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for solid tumors include chemotherapy, which works by killing rapidly dividing cancer cells; targeted therapy, which blocks specific molecules involved in tumor growth and progression; immunotherapy, which enhances the body's immune system to recognize and destroy cancer cells; and hormone therapy, which blocks hormones that fuel certain cancers. These mechanisms are vital for solid tumor patients as they provide multiple avenues to attack the cancer, potentially improving outcomes and allowing for personalized treatment plans based on the tumor's specific characteristics.

Current trends and future directions in the genetic therapy of human neoplastic disease.