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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
Subject must be ≥18 years-of-age at the time of signature of the informed consent form (ICF).
Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
Must not have
Severe autoimmune disease (including immune-related adverse events of prior immune-oncology therapy) or autoimmune disorder that requires chronic systemic corticosteroid treatment at immunosuppressive doses (prednisone >10 mg/day or equivalent).
Known malignant central nervous system disease other than neurologically stable, treated brain metastases.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 2 years
Awards & highlights
Summary
This trial tests a new drug called JAB-3312, taken regularly, in about 24 participants. The goal is to find a safe dosage and understand potential side effects.
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.
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.
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 belowSelect...
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 cancer has worsened despite treatment or there's no standard treatment for it.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a severe autoimmune disease or need high-dose steroids.
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I have brain metastases but they are stable and treated.
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I have a history of serious eye inflammation or blood vessel problems.
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I haven't taken any cancer drugs or experimental drugs in the last 28 days, except for prostate cancer treatment.
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I have had lung conditions that needed steroids or procedures to remove fluid.
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I do not have any serious or active infections.
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I have had a bone marrow or organ transplant from another person.
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I have no major side effects from previous treatments.
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I haven't had radiation therapy in the last 28 days and don't expect to need it soon.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Find Recommended Phase 2 Dose (RP2D) of JAB-3312
Number of participants with dose limiting toxicities
Secondary study objectives
Area under the curve
Cmax
Duration of response ( DOR )
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: JAB-3312Experimental Treatment1 Intervention
JAB-3312 will be administered orally once daily in 21 days treatment cycles.
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
The most common treatments for esophageal cancer include chemotherapy, targeted therapy, and chemoradiotherapy. Chemotherapy drugs like cisplatin, fluorouracil (5-FU), and paclitaxel work by interfering with DNA replication and cell division, leading to cancer cell death.
Targeted therapies, such as those inhibiting the epidermal growth factor receptor (EGFR) or human epidermal growth factor receptor 2 (HER2), block specific molecules involved in tumor growth and progression. Chemoradiotherapy combines chemotherapy with radiation therapy to enhance the cytotoxic effects on cancer cells.
These treatments are crucial for esophageal cancer patients as they aim to reduce tumor size, control disease spread, and improve survival rates. Understanding these mechanisms helps in tailoring personalized treatment plans and exploring new therapeutic options like JAB-3312, which may offer additional benefits in managing advanced solid tumors.
Find a Location
Who is running the clinical trial?
Jacobio Pharmaceuticals Co., Ltd.Lead Sponsor
20 Previous Clinical Trials
2,135 Total Patients Enrolled
Jacobio PharmaceuticalsStudy DirectorJacobio Pharmaceuticals
10 Previous Clinical Trials
1,072 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had lung conditions that needed steroids or procedures to remove fluid.I am 18 years old or older.I do not have any serious or active infections.I have had a bone marrow or organ transplant from another person.I am fully active or can carry out light work.I have brain metastases but they are stable and treated.I have a severe autoimmune disease or need high-dose steroids.I haven't taken any cancer drugs or experimental drugs in the last 28 days, except for prostate cancer treatment.I haven't had radiation therapy in the last 28 days and don't expect to need it soon.I have no major side effects from previous treatments.You have tested positive for hepatitis B, hepatitis C, or HIV in the past.Patients must have at least one specific area of the body that can be measured according to a certain standard.I have a history of serious eye inflammation or blood vessel problems.My organs are functioning well.I have not had a blood transfusion in the last 2 weeks.My cancer has worsened despite treatment or there's no standard treatment for it.
Research Study Groups:
This trial has the following groups:- Group 1: JAB-3312
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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