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Antiandrogen
TVB-2640 + Enzalutamide for Prostate Cancer
Phase 1
Recruiting
Led By David Nanus, M.D.
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline until disease progression for a maximum of 2 years from enrollment
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing the safety of combining two drugs to see if they can fight prostate cancer that has spread and not responded to other treatments.
Who is the study for?
Men over 18 with metastatic, castration-resistant prostate cancer that hasn't improved with prior treatment can join. They must be willing to undergo biopsies and have not had cytotoxic chemotherapy for hormone-sensitive prostate cancer. Participants should plan to take Enzalutamide as their first therapy or have had one line of similar treatments.
What is being tested?
The trial is testing the combination of TVB-2640 and Enzalutamide in treating advanced prostate cancer. It's a Phase I study, which means it's mainly looking at the safety and side effects of this new drug combo.
What are the potential side effects?
Specific side effects are not listed, but since this is a Phase I trial, part of its purpose is to determine what those might be from combining TVB-2640 with Enzalutamide.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline until disease progression for a maximum of 2 years from enrollment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline until disease progression for a maximum of 2 years from enrollment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Optimal dose of TVB-2640 in combination with Enzalutamide, as determined by the maximum tolerated dose (MTD)
Secondary study objectives
Mean Enzalutamide clearance
Mean Enzalutamide total exposure (as measured by the area under the drug serum concentration vs. the time from administration curve [AUC])
Mean Enzalutamide volume of distribution at steady state
+16 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: TVB-2640 in combination with EnzalutamideExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TVB-2640
2019
Completed Phase 2
~550
Enzalutamide
2014
Completed Phase 4
~3820
Find a Location
Who is running the clinical trial?
Weill Medical College of Cornell UniversityLead Sponsor
1,086 Previous Clinical Trials
1,147,317 Total Patients Enrolled
49 Trials studying Prostate Cancer
34,597 Patients Enrolled for Prostate Cancer
Sagimet Biosciences Inc.Industry Sponsor
9 Previous Clinical Trials
3,830 Total Patients Enrolled
David Nanus, M.D.Principal InvestigatorWeill Medical College of Cornell University
1 Previous Clinical Trials
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have received chemotherapy for hormone-sensitive prostate cancer.I haven't had any cancer treatment except for bone agents in the last 4 weeks.I haven't had radiation for bone metastasis in 2 weeks, other radiation in 4 weeks, or radionuclide treatment in 6 weeks.My brain metastases are treated and stable for at least 4 weeks.I am currently on blood thinners like warfarin or betrixaban.I have severe dry eyes or issues with the surface of my eyes.I agree to have a biopsy of my cancer after 4 weeks of treatment.I haven't used herbal products that could lower PSA levels in the last 4 weeks.I haven't had serious heart problems or a stroke in the last 6 months.I cannot swallow pills.I am willing to have a biopsy if my recent tissue samples are not available.I am older than 18 years.My prostate cancer has spread and is not responding to hormone therapy.I am planning to start or have only had one prior treatment for advanced prostate cancer.I have not had chemotherapy that kills cells.I am on LHRH therapy and willing to continue it for the study.I have had seizures in the past.I haven't had any cancer besides skin cancer or low-grade tumors in the past 2 years.
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: TVB-2640 in combination with Enzalutamide
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