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JAB-3312 for Cancer

Phase 1
Waitlist Available
Research Sponsored by Jacobio Pharmaceuticals Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
Subjects with histologically or cytologically confirmed advanced solid tumors which have progressed despite standard therapy or for which no standard therapy exists.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 2 years
Awards & highlights

Study Summary

This trial is testing a new drug, JAB-3312, to see what the maximum tolerated dose is. JAB-3312 will be taken once daily orally, and the study will last 21 days per cycle. They expect to enroll 24 people in this phase of the study.

Who is the study for?
Adults over 18 with advanced solid tumors that have worsened after standard treatment or lack a standard treatment option. They must be in relatively good health (ECOG score of 0 or 1), have a life expectancy of at least three months, and sufficient organ function. Tumors should be measurable by RECIST v1.1 criteria.Check my eligibility
What is being tested?
The trial is testing JAB-3312, an oral medication for various advanced cancers. It aims to find the highest dose patients can take without serious side effects (MTD) and suggest a Phase 2 dose (RP2D). Participants will take JAB-3312 daily in cycles of 21 days.See study design
What are the potential side effects?
As this is a first-in-human study, specific side effects are not yet known but may include typical reactions to cancer medications such as nausea, fatigue, blood count changes, and potential drug-specific toxicities which will be monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or can carry out light work.
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My cancer has worsened despite treatment or there's no standard treatment for it.
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I am 18 years old or older.
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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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My cancer has worsened despite treatment or there's no standard treatment for it.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 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
Find Recommended Phase 2 Dose (RP2D) of JAB-3312
Number of participants with dose limiting toxicities
Secondary outcome measures
Area under the curve
Cmax
Duration of response ( DOR )
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: JAB-3312Experimental Treatment1 Intervention
JAB-3312 will be administered orally once daily in 21 days treatment cycles.

Find a Location

Who is running the clinical trial?

Jacobio Pharmaceuticals Co., Ltd.Lead Sponsor
18 Previous Clinical Trials
1,546 Total Patients Enrolled
Jacobio PharmaceuticalsStudy DirectorJacobio Pharmaceuticals
9 Previous Clinical Trials
694 Total Patients Enrolled

Media Library

JAB-3312 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04045496 — Phase 1
Esophageal Cancer Research Study Groups: JAB-3312
Esophageal Cancer Clinical Trial 2023: JAB-3312 Highlights & Side Effects. Trial Name: NCT04045496 — Phase 1
JAB-3312 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04045496 — Phase 1

Frequently Asked Questions

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

What aims does this research endeavor hope to accomplish?

"This medical trial will be monitored for a period of two years, with the purpose of discovering an effective dosage rate (RP2D) of JAB-3312. Secondary objectives involve tracking adverse events and their severity, calculating plasma concentration time curves, and measuring peak concentrations in patients' blood samples."

Answered by AI

Has JAB-3312 been sanctioned by the FDA?

"Our team's assessment of JAB-3312 safety is rated 1 due to the fact that there are limited data points indicating its efficacy and security in Phase 1."

Answered by AI

What is the geographic scope of this experiment?

"At the moment, 4 separate clinical trial sites are running this research. These locales include Nashville, Denver and Houston as well as a quartet of additional facilities. For participants' convenience, it is best to choose the test centre closest to your home to reduce travelling demands."

Answered by AI

Are there still vacancies available for participants in this research endeavor?

"Affirmative. According to the information available on clinicaltrials.gov, this study is presently enrolling participants who were initially posted in September 2019 and last updated in March 2022. The trial requires the recruitment of 24 patients from 4 distinct sites."

Answered by AI

What is the current quota for enrolling participants in this clinical trial?

"This clinical trial necessitates 24 participants who meet the inclusion requirements. Those interested may join at either Tennessee Oncology, PLLC in Nashville or HealthONE Clinic Services Oncology-Hematology in Denver."

Answered by AI
~4 spots leftby Mar 2025