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ZX-4081 for Advanced Cancer
Phase 1
Waitlist Available
Research Sponsored by Nanjing Zenshine Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Metastatic or locally advanced solid tumor malignancies (breast cancer, urothelial cancer, ovarian cancer, melanoma, NSCLC, renal cell carcinoma, squamous cell cancer of the head and neck, colorectal cancer, and hepatocellular carcinoma) that has progressed on, is refractory to, intolerant to, or for which there is no curative standard of care therapy
Age ≥18 years at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing a new drug, ZX-4081, to see if it is safe and effective in treating patients with advanced solid tumors.
Who is the study for?
Adults (18+) with advanced solid tumors like breast, lung, or liver cancer that have worsened despite treatment can join. They must have measurable disease, good organ function, and a life expectancy over 12 weeks. Women who can get pregnant and men must agree to use birth control. People with untreated brain tumors, certain heart diseases, active infections including COVID-19 or hepatitis B/C with detectable virus are excluded.Check my eligibility
What is being tested?
ZX-4081 is being tested in patients with various advanced cancers. This Phase 1 trial involves taking the drug orally twice daily in cycles of 28 days to check its safety, how well it's tolerated by the body (tolerability), how the body processes it (pharmacokinetics), its effects on tumor biology (pharmacodynamics), and initial effectiveness against cancer.See study design
What are the potential side effects?
Specific side effects for ZX-4081 aren't listed but may include typical reactions seen with cancer treatments such as nausea, fatigue, blood count changes leading to increased infection risk or bleeding tendencies; organ-specific toxicity affecting liver or kidney function; and potential allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has spread or worsened despite treatment.
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I am 18 years old or older.
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I can take care of myself and am up and about more than 50% of my waking hours.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determine the recommended Phase 2 dose (RP2D) of ZX-4081
Safety and tolerability of ZX-4081
Secondary outcome measures
Area under the plasma concentration of ZX-4081
Duration of Response (DOR)
Half-life of ZX-4081
+6 moreTrial Design
7Treatment groups
Experimental Treatment
Group I: ZX-4081 Expansion Dose LevelExperimental Treatment1 Intervention
Recommended Phase 2 Dose (RP2D) (to be determined) of ZX-4081 administered orally BID in a 28-day cycle
Group II: ZX-4081 Dose Level 6Experimental Treatment1 Intervention
10-times the SD of ZX-4081 administered orally BID in a 28-day cycle
Group III: ZX-4081 Dose Level 5Experimental Treatment1 Intervention
8-times the SD of ZX-4081 administered orally BID in a 28-day cycle
Group IV: ZX-4081 Dose Level 4Experimental Treatment1 Intervention
6-times the SD of ZX-4081 administered orally BID in a 28-day cycle
Group V: ZX-4081 Dose Level 3Experimental Treatment1 Intervention
4-times the SD of ZX-4081 administered orally BID in a 28-day cycle
Group VI: ZX-4081 Dose Level 2Experimental Treatment1 Intervention
2-times the SD of ZX-4081 administered orally BID in a 28-day cycle
Group VII: ZX-4081 Dose Level 1Experimental Treatment1 Intervention
Starting dose (SD) of ZX-4081 administered orally twice daily (BID) in a 28-day cycle
Find a Location
Who is running the clinical trial?
Nanjing Zenshine PharmaceuticalsLead Sponsor
10 Previous Clinical Trials
878 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread or worsened despite treatment.My condition can be treated with the goal of curing it.My side effects from previous treatments have mostly gone away, except for hair loss or skin color changes.I haven't used cancer treatments like chemotherapy or immunotherapy in the last 28 days or more.I am taking more than 10 mg/day of prednisone or its equivalent.My heart health is stable and I don't have severe heart issues or uncontrolled illnesses.I do not have active HIV, Hepatitis, or COVID-19. If I have Hepatitis B or C, my viral load is undetectable.I am 18 years old or older.I am a man who cannot father a child or will use birth control during and after the study.I can take care of myself and am up and about more than 50% of my waking hours.My organ functions are within normal ranges as per recent tests.I am currently being treated for an infection.I have no active cancer except for certain skin, cervical, or superficial bladder cancers.My brain or spinal cord cancer has not been treated or is not under control.
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.
Research Study Groups:
This trial has the following groups:- Group 1: ZX-4081 Dose Level 6
- Group 2: ZX-4081 Dose Level 2
- Group 3: ZX-4081 Dose Level 3
- Group 4: ZX-4081 Expansion Dose Level
- Group 5: ZX-4081 Dose Level 4
- Group 6: ZX-4081 Dose Level 5
- Group 7: ZX-4081 Dose Level 1
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people are volunteering their services for this clinical experiment?
"Affirmative. According to clinicaltrials.gov, the trial posted on March 1st 2022 is still actively recruiting patients across one site with a desired total of 60 participants."
Answered by AI
Is registration still available for this research study?
"Affirmative. Clinicaltrials.gov's dataset attests to this study's ongoing recruitment process, which was instigated on January 3rd 2022 and most recently amended on the 18th of that same month. This medical trial necessitates 60 patients from a single clinical facility for completion."
Answered by AI
What goals are researchers striving to achieve by conducting this clinical trial?
"The principal goal of this clinical trial, which will be tracked for 28 day cycles, is to gauge the safety and tolerability of ZX-4081. Secondary aims include gauging response rates according to disease criteria, progression free survival as measured by time from first dose until observed progressive decline or death due to any cause, and peak plasma concentration following both single and repeated doses administered twice daily."
Answered by AI
Has ZX-4081 been given clearance by the FDA?
"Because this is an early-stage trial, the safety profile of ZX-4081 has been assessed to be a 1. At this time there is only limited data confirming its efficacy and security."
Answered by AI
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