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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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial studies the safety and effectiveness of a new cancer drug on 54 advanced solid tumor patients with no further treatment available. One cycle is 21 days.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Anti-drug antibodies (ADA)

Disease control rate (DCR)

Duration of response (DOR)

+10 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: HB0045Experimental Treatment1 Intervention

HB0045 IV every 3 weeks (q3w)

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteOTHER

1,079 Previous Clinical Trials

340,909 Total Patients Enrolled

Shanghai Huaota Biopharmaceutical Co., Ltd.Lead Sponsor

6 Previous Clinical Trials

262 Total Patients Enrolled

Gabrail Cancer Center ResearchOTHER

2 Previous Clinical Trials

85 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial still open to enrollment?

"Clinicaltrials.gov indicates that recruitment for this trial has concluded; it was initially posted on September 20th, 2023 and last updated the same day. Nonetheless, there are 2604 other studies taking part in patient enrollment at present."

Answered by AI

What is the intention of this research endeavor?

"The primary purpose of this study is to establish the Maximum Tolerated Dose (MTD) over a 21 day period. Secondary objectives include measuring serum concentration using ELISA, calculating half-life by non-compartmental analysis with Phoenix WinNonlin version 8.3, and determining time of maximum concentration after four cycles administration."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of HB0045 Injection in Patients With Advanced Solid Tumors

2023. "A Study of HB0045 Injection in Patients With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06056323.