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AXL Kinase Inhibitor

TP-0903 for Non-Small Cell Lung Cancer

Phase 1
Waitlist Available
Research Sponsored by Sumitomo Pharma America, 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 end of every cycle (each cycle is 28 days) and end of study (within 14 days of the last dose of study drug or within 14 days of the decision to discontinue study treatment)
Awards & highlights

Study Summary

This trial is testing a new drug, TP-0903, to see if it is safe and effective in treating patients with advanced solid tumors. The study will also explore if the drug has any potential biomarkers or signals of activity.

Eligible Conditions
  • Solid Tumors
  • Non-Small Cell Lung Cancer
  • Colorectal Cancer
  • Ovarian Cancer
  • Melanoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of every cycle (each cycle is 28 days) and end of study (within 14 days of the last dose of study drug or within 14 days of the decision to discontinue study treatment)
This trial's timeline: 3 weeks for screening, Varies for treatment, and end of every cycle (each cycle is 28 days) and end of study (within 14 days of the last dose of study drug or within 14 days of the decision to discontinue study treatment) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of dose-limiting toxicities (DLTs) and treatment emergent adverse events
Secondary outcome measures
Activity of TP-0903 on predictive biomarkers
Area under the plasma concentration-time curve from zero to infinity [AUC(0-inf)] of oral TP-0903
Area under the plasma concentration-time curve from zero to last measured time point [AUC(0-last)] of oral TP-0903
+2 more

Trial Design

5Treatment groups
Experimental Treatment
Group I: Persistent/Recurrent Ovarian CancerExperimental Treatment1 Intervention
Phase 1b - Upon confirmation of MTD, will receive single oral daily doses of a flat dose of TP-0903 based on the average of the dose administered in the MTD expansion safety cohort on Days 1-21 of each 28 day cycle.
Group II: EGFR+ NSCLCExperimental Treatment1 Intervention
Phase 1b - Upon confirmation of MTD, will receive single oral daily doses of a flat dose of TP-0903 based on the average of the dose administered in the MTD expansion safety cohort on Days 1-21 of each 28 day cycle.
Group III: BRAF-Mutated MelanomaExperimental Treatment1 Intervention
Phase 1b - Upon confirmation of MTD, will receive single oral daily doses of a flat dose of TP-0903 based on the average of the dose administered in the MTD expansion safety cohort on Days 1-21 of each 28 day cycle.
Group IV: BRAF-, KRAS-, or NRAS-Mutated CRCExperimental Treatment1 Intervention
Phase 1b - Upon confirmation of MTD, will receive single oral daily doses of a flat dose of TP-0903 based on the average of the dose administered in the MTD expansion safety cohort on Days 1-21 of each 28 day cycle.
Group V: Advanced Solid TumorsExperimental Treatment1 Intervention
Phase 1a Single daily dose of TP-0903 by oral administration on Days 1-21 of a 28 day cycle AND Phase 1b - Upon confirmation of MTD, will receive single oral daily doses of a flat dose of TP-0903 based on the average of the dose administered in the MTD expansion safety cohort on Days 1-21 of each 28 day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TP-0903
2016
Completed Phase 1
~180

Find a Location

Who is running the clinical trial?

Sumitomo Pharma America, Inc.Lead Sponsor
236 Previous Clinical Trials
52,543 Total Patients Enrolled
Sumitomo Dainippon Pharma Oncology, IncLead Sponsor
41 Previous Clinical Trials
6,451 Total Patients Enrolled
Sumitomo Pharma Oncology, Inc.Lead Sponsor
44 Previous Clinical Trials
6,772 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
First-in-human Study of Oral TP-0903 (a Novel Inhibitor of AXL Kinase) in Patients With Advanced Solid Tumors
2016. "First-in-human Study of Oral TP-0903 (a Novel Inhibitor of AXL Kinase) in Patients With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02729298.
~21 spots leftby Apr 2025
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