Your session is about to expire
← Back to Search
TT-00420 + Nab-Paclitaxel for Advanced Cancers
Phase 1 & 2
Waitlist Available
Led By Sarina A. Piha-Paul, MD
Research Sponsored by TransThera Sciences (Nanjing), Inc.
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 first study drug administration until the date of death from any cause, assessed up to 24 months
Awards & highlights
Study Summary
This trial is testing a new tablet drug to see if it is safe and effective in treating patients with advanced solid tumors.
Who is the study for?
Adults with advanced solid tumors lacking standard treatment options can join this trial. They must have at least one measurable tumor, proper organ function, and an ECOG status of 0 or 1. Participants need to use effective birth control and cannot be pregnant. Those who've had recent corticosteroids, certain therapies, major surgery, live vaccines, or specific drugs are excluded.Check my eligibility
What is being tested?
The study is testing TT-00420 tablets alone or combined with Nab-Paclitaxel in patients with various advanced cancers. It's a Phase Ib/II trial assessing the safety and initial effectiveness of these treatments across multiple centers.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include typical reactions to cancer medications such as nausea, fatigue, blood count changes (affecting immunity), liver function alterations, allergic reactions to the tablet components or Nab-Paclitaxel infusion-related issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from first study drug administration until the date of death from any cause, assessed up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first study drug administration until the date of death from any cause, assessed up to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose limiting toxicity (DLT)
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Secondary outcome measures
Area under the curve (AUC0-t)
Area under the curve (AUC0-∞)
Disease Control Rate (DCR)
+8 moreOther outcome measures
Genetic Alteration Status
Trial Design
3Treatment groups
Experimental Treatment
Group I: PK Run-in CohortsExperimental Treatment1 Intervention
TT-00420 tablets will be administered once or twice daily in 28-day cycles according to assigned cohort.
Group II: Monotherapy CohortsExperimental Treatment1 Intervention
TT-00420 tablets will be administered once daily in 28-day cycles.
Group III: Dose Escalation Cohorts (Combination Therapy)Experimental Treatment2 Interventions
TT-00420 tablets will be administered once daily in 28-day cycles. Nab-paclitaxel 100 mg/m^2 will be administered intravenously on Day 1, 8, and 15 of each 28-day cycle. Dose escalation will be guided by a 3+3 design in Phase Ib to determine the recommended phase 2 dose (RP2D).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nab-Paclitaxel
2014
Completed Phase 3
~4340
Find a Location
Who is running the clinical trial?
TransThera Sciences (Nanjing), Inc.Lead Sponsor
13 Previous Clinical Trials
708 Total Patients Enrolled
Sarina A. Piha-Paul, MDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
48 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger