TT-00420 for Bile Duct Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Bile Duct Cancer+4 MoreTT-00420 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study how well TT-00420 works in treating patients with advanced cholangiocarcinoma, as well as assessing its safety.

Eligible Conditions
  • Bile Duct Cancer
  • Fibroblast Growth Factor Receptor 3 Alteration
  • FGFR2 Gene Mutation
  • FGFR2 Fusion
  • Fibroblast Growth Factor Receptor 1 Alteration

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

4 Primary · 6 Secondary · Reporting Duration: From first study drug administration until the date of death from any cause, assessed up to 24 months

Month 4
Concentration of TT-00420 at Protocol-Specified Timepoints (All Cohorts)
Month 24
Overall Survival (OS) (All Cohorts)
Month 24
Progression Free Survival (PFS) (All Cohorts)
Month 9
Genetic Alteration Status
Month 9
Disease Control Rate (DCR) (All Cohorts)
ORR in all patients with FGFR alterations (Cohorts A and B)
ORR in patients with FGFR alterations other than FGFR2 fusions (Cohort B)
ORR in patients with FGFR2 fusions who have responded (CR or PR) on at least one previous treatment with an FGFR inhibitor and discontinued due to progressive disease (Cohort A2)
ORR in patients without FGFR alterations (wild-type FGFR mutation status) (Cohort C)
Objective Response Rate (ORR) in patients with FGFR2 fusions who have failed at least one previous treatment with an FGFR inhibitor (Cohort A1)
Day 30
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment (All Cohorts)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

4 Treatment Groups

Cohort B
1 of 4
Cohort A2
1 of 4
Cohort A1
1 of 4
Cohort C
1 of 4

Experimental Treatment

80 Total Participants · 4 Treatment Groups

Primary Treatment: TT-00420 · No Placebo Group · Phase 2

Cohort B
Drug
Experimental Group · 1 Intervention: TT-00420 · Intervention Types: Drug
Cohort A2
Drug
Experimental Group · 1 Intervention: TT-00420 · Intervention Types: Drug
Cohort A1
Drug
Experimental Group · 1 Intervention: TT-00420 · Intervention Types: Drug
Cohort C
Drug
Experimental Group · 1 Intervention: TT-00420 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from first study drug administration until the date of death from any cause, assessed up to 24 months

Who is running the clinical trial?

TransThera Sciences (Nanjing), Inc.Lead Sponsor
11 Previous Clinical Trials
647 Total Patients Enrolled
Milind Javle, MDPrincipal InvestigatorM.D. Anderson Cancer Center
6 Previous Clinical Trials
97 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a performance status of 0 or 1.
Hemoglobin (Hgb) ≥ 8 g/dl.
You are negative for FGFR alterations (FGFR wild-type).
You have at least one measurable lesion as defined by RECIST V1.1 criteria for solid tumors.
AST/SGOT > 2.5 x ULN or ALT/SGPT > 5.0 x ULN if liver metastases are present.