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WGI-0301 for Solid Tumors

Phase 1

Recruiting

Research Sponsored by Zhejiang Haichang Biotech Co., Ltd.

Eligibility Criteria Checklist

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

Must have

Advanced, histologically or cytologically confirmed solid tumors who have progressed from current therapy or who have relapsed after prior therapy and are not candidates for potentially curative therapy

Patients with advanced solid tumors (unresectable or metastatic) who failed standard therapy (disease progression or intolerance)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 16 months

Awards & highlights

Study Summary

This trialis testing an experimental drug to find safe & effective doses to treat solid tumors. It also looks at how the drug is taken up & affects the body.

Who is the study for?

Adults (18+) with advanced solid tumors that have worsened after treatment or are untreatable, who can understand and consent to the study. They must be in fairly good health overall, not pregnant, willing to use contraception, and expected to live at least 12 weeks. People with certain other medical conditions or treatments are excluded.Check my eligibility

What is being tested?

The trial is testing WGI-0301's safety and optimal dosing for treating solid tumors. It involves studying how the body absorbs it (pharmacokinetics) and its effects on the body (pharmacodynamics).See study design

What are the potential side effects?

Specific side effects of WGI-0301 aren't listed but generally may include reactions at the infusion site, fatigue, nausea, blood count changes, organ inflammation or dysfunction due to drug toxicity.

Eligibility Criteria

Inclusion Criteria

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

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My cancer has returned or worsened after treatment and cannot be cured with surgery or other therapies.

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My advanced cancer did not respond to standard treatments.

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My blood tests show normal white blood cells, platelets, hemoglobin, and albumin levels.

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I am 18 years old or older.

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My kidney function is good, with an eGFR of 50 mL/min or higher.

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My cancer is a solid tumor confirmed by a biopsy.

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My liver functions within normal limits, or slightly above if due to my cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 16 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 16 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 16 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Recommended Phase 2 Dose of WGI-0301

Safety and tolerability

Secondary outcome measures

Area under the curve

Half-life

Maximum plasma concentration

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: WGI-0301Experimental Treatment1 Intervention

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Zhejiang Haichang Biotech Co., Ltd.Lead Sponsor

1 Previous Clinical Trials

60 Total Patients Enrolled

Media Library

WGI-0301 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05267899 — Phase 1

Solid Tumors Research Study Groups: WGI-0301

Solid Tumors Clinical Trial 2023: WGI-0301 Highlights & Side Effects. Trial Name: NCT05267899 — Phase 1

WGI-0301 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05267899 — Phase 1

Frequently Asked Questions

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

What sort of adverse reactions have been observed with WGI-0301?

"With limited clinical data to back it, WGI-0301 has been assessed as having a 1 rating for safety. This is because it is currently in the first phase of testing and its efficacy remains uncertain."

Answered by AI

Is this experiment recruiting participants currently?

"Affirmative, clinicaltrials.gov attests that the recruitment phase for this study is ongoing since its August 1st 2022 launch date and most recent October 25th update. The research requires 24 participants from two separate facilities."

Answered by AI

For what purpose is this research endeavor being conducted?

"The main outcome of this 16-month trial is to ascertain the Recommended Phase 2 Dose of WGI-0301. Other measurements include evaluating Area under the Curve, Half-life and Time of maximum plasma concentration for the pharmaceutical agent."

Answered by AI

How extensive is the participant database for this clinical research?

"Affirmative. According to the details on clinicaltrials.gov, this experiment is actively seeking participants after first being posted 8/1/2022 and last updated 10/25/2022. The researchers are looking for 24 people from two sites to join the trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase I First in Human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of WGI-0301 in Patients With Advanced Solid Tumors

2022. "A Phase I First in Human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of WGI-0301 in Patients With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05267899.