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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
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I have a tumor that can be measured by scans.
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I am fully active or can carry out light work.
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My kidneys work well enough (CrCL > 30 mL/min).
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My cancer has spread or returned and standard treatments haven't worked.
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My doctor expects me to live for at least 12 more weeks.
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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:
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I have an active autoimmune disease.

Timeline

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)

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.

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteOTHER
1,107 Previous Clinical Trials
357,052 Total Patients Enrolled
Shanghai Huaota Biopharmaceutical Co., Ltd.Lead Sponsor
8 Previous Clinical Trials
341 Total Patients Enrolled
Gabrail Cancer Center ResearchOTHER
2 Previous Clinical Trials
85 Total Patients Enrolled
~27 spots leftby Sep 2025
Unbiased ResultsWe believe in providing patients with all the options.
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