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.

← Back to Search

Other

HB0045 Injection for Advanced Solid Cancers

Phase 1 & 2

Recruiting

Research Sponsored by Shanghai Huaota Biopharmaceutical Co., Ltd.

Eligibility Criteria Checklist

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

Must have

a) Pancreatic cancer cohort: i. Histologically or cytologically confirmed pancreatic ductal adenocarcinoma. ii. Unresectable, locally advanced recurrent or metastatic. b) CRC cohort: i. Histologically or cytologically confirmed colorectal cancer. ii. Molecular typing: non-dMMR/ non-MSI-H colorectal cancer. c) Ovarian cancer cohort: i. Histologically or cytologically confirmed unresectable metastatic ovarian, fallopian tube or peritoneal cancer ii. Epithelial type including high-grade serous cell carcinoma, endometrioid carcinoma or clear cell carcinoma.

At least one measurable lesion as per RECIST v. 1.1 defined as non-nodal lesions having at least one dimension with a minimum size of 10 mm in the longest diameter by CT or MRI scan or ≥15 mm in short axis for nodal lesions. Radiographic disease assessment at baseline can be performed up to 21 days prior to the first dose.

Must not have

Active autoimmune disease or

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 with advanced solid tumors who've tried all standard treatments without success are eligible for this trial. They must understand the study, be willing to follow procedures, and have a life expectancy of at least 12 weeks. Key requirements include proper organ function, no recent severe bowel issues or surgeries, and controlled prior treatment side effects (except hair loss and mild neuropathy). Specific cancer types like pancreatic, colorectal, ovarian among others are included.

What is being tested?

The HB0045 drug is being tested in patients with various advanced solid tumors to assess its safety, tolerability, how it affects the body (pharmacokinetics/pharmacodynamics), immune response it triggers (immunogenicity), potential biomarkers for effectiveness and its ability to fight cancer.

What are the potential side effects?

While specific side effects aren't listed here as this is an early-phase trial assessing safety and tolerability generally expected side effects may include reactions at the injection site, fatigue, nausea or other digestive issues; changes in blood counts affecting immunity; possible allergic reactions; liver or kidney function changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have a tumor that can be measured by scans.

Select...

I am fully active or can carry out light work.

Select...

My kidneys work well enough (CrCL > 30 mL/min).

Select...

My cancer has spread or returned and standard treatments haven't worked.

Select...

My doctor expects me to live for at least 12 more weeks.

Select...

I haven't had any blockage in my intestines in the last 3 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have an active autoimmune disease.

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)

0 / 8Eligibility criteria met

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.