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Protein Tyrosine Phosphatase Inhibitor

SHP2 Inhibitor for Solid Cancers

Phase 1
Recruiting
Led By Ravi Salgia, MD
Research Sponsored by HUYABIO International, LLC.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Relapsed or refractory to, or intolerant of, or refuse approved or standard of care established therapy known to provide clinical benefit for disease
Advanced malignant solid tumors with KRAS or EGFR mutations diagnosed by histology or cytology
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months
Awards & highlights

Study Summary

This trial is testing a new drug to see what dose is tolerated by patients and what the side effects are.

Who is the study for?
Adults with advanced solid tumors that have specific mutations (KRAS or EGFR) and who have not responded to standard treatments can join. They must be able to take pills, have good organ function, and a performance status indicating they are relatively active. People with untreated brain metastases, recent heart issues, ongoing severe side effects from past cancer treatment, pregnancy, or autoimmune diseases cannot participate.Check my eligibility
What is being tested?
The trial is testing HBI-2376's safety at different doses in patients with certain genetic mutations in their tumors. It aims to find the highest dose patients can tolerate without severe side effects and will also see how the body processes the drug.See study design
What are the potential side effects?
While specific side effects of HBI-2376 aren't listed here, common ones for cancer drugs include nausea, fatigue, risk of infection due to low blood cell counts, liver problems which might show as yellow skin or eyesight changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My condition did not improve, or I cannot tolerate, or I refuse standard treatments.
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My cancer has KRAS or EGFR mutations.
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I am 18 years or older and have agreed to participate in this study.
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I am fully active or can carry out light work.
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My organs are functioning well.
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I can take pills and don't have major stomach or intestine issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 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
To determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), of HBI-2376 as an oral monotherapy for advanced solid tumors harboring KRAS or EGFR mutations.
Secondary outcome measures
Pharmacokinetic variables including Area Under the Curve (AUC)
Pharmacokinetic variables including clearance
Pharmacokinetic variables including maximum plasma concentration (Cmax)
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Dose Escalation and ExpansionExperimental Treatment1 Intervention
HBI-2376 will be given orally in ascending doses (escalation cohort), until the maximum tolerated dose or recommended Phase 2 dose is reached. Up to 6 patients will then be enrolled in the expansion cohort at the recommended dose.

Find a Location

Who is running the clinical trial?

HUYABIO International, LLC.Lead Sponsor
11 Previous Clinical Trials
937 Total Patients Enrolled
Ravi Salgia, MDPrincipal InvestigatorCity of Hope Comprehensive Cancer Center
1 Previous Clinical Trials

Media Library

HBI-2376 (Protein Tyrosine Phosphatase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05163028 — Phase 1
Non-Small Cell Lung Cancer Research Study Groups: Dose Escalation and Expansion
Non-Small Cell Lung Cancer Clinical Trial 2023: HBI-2376 Highlights & Side Effects. Trial Name: NCT05163028 — Phase 1
HBI-2376 (Protein Tyrosine Phosphatase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05163028 — Phase 1

Frequently Asked Questions

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

Is HBI-2376 a risk to the public's well-being?

"There is restricted clinical data substantiating the safety of HBI-2376, so it obtained a score of 1."

Answered by AI

How many medical facilities are participating in this clinical research?

"This study is enrolling participants at Providence Medical Foundation in Fullerton, Florida; City of Hope in Duarte, Ohio; and California Cancer Associates for Research and Excellence (cCare) Inc. in Encinitas, Texas as well as 11 other medical sites."

Answered by AI

Are new participants being accepted for this clinical trial?

"Clinicaltrials.gov confirms that this clinical trial is currently looking for participants to join, with the initial post made on December 13th 2021 and the most recent edit being August 23rd 2022."

Answered by AI

How many people have enrolled in this research endeavor?

"Affirmative. As observed on clinicaltrials.gov, this medical trial is actively recruiting participants with an initial posting date of December 13th 2021 and a last update occurring August 23rd 2022. Altogether there are 11 different sites looking to enrol 42 individuals in the study."

Answered by AI
~10 spots leftby Dec 2024