Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02325739 | FGF401 in HCC and Solid Tumors Characterized by Positive FGFR4 and KLB Expression | PHASE1 | COMPLETED | 172 | — | — | Dec 29, 2014 | May 30, 2019 | Oct 21, 2024 | 27 | United States, China +9 |
A dose-limiting toxicity was defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurred within the evaluation period of DLTs and met any of the criteria listed. The estimation of the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of the treatment was based upon the estimation of the probability of DLT during the evaluation period for subjects in the dose determining set (DDS). A subject with multiple occurrences of a DLT under one treatment is counted only once in the AE category for that treatment. A subject with multiple DLTs within a primary system organ class is counted only once in the total row.
TTP is defined as the date of start treatment to the date of event defined as the first documented progression or death due to underlying cancer. Method used was Kaplan-Meier analysis. Group 1: HCC subjects form Asian countries; Group 2: HCC subjects form non-Asian countries
ORR is defined as the percentage of patients with a best overall response of CR or PR (RECIST v1.1). FGF401 single agent-Phase II part - Group 3 (non-HCC, other solid tumors).
| Arm | Type | Description |
|---|---|---|
| Phase I: FGF401 50 mg fasted | EXPERIMENTAL | Participants received single agent FGF401 50 mg while fasted |
| Phase I: FGF401 80 mg fasted | EXPERIMENTAL | Participants received single agent FGF401 80 mg while fasted |
| Phase I: FGF401 80 mg fed | EXPERIMENTAL | Participants received single agent FGF401 80 mg while fed |
| Phase I: FGF401 120 mg fasted | EXPERIMENTAL | Participants received single agent FGF401 120 mg while fasted |
| Phase I: FGF401 120 mg fed | EXPERIMENTAL | Participants received single agent FGF401 120 mg while fed |
| Phase I: FGF401 150 mg fasted | EXPERIMENTAL | Participants received single agent FGF401 150 mg while fasted |
| Phase I: FGF401 80 mg + PDR001 300 mg | EXPERIMENTAL | Participants received FGF401 80 mg in combination with PDR001 300 mg while fasted |
| Phase I: FGF401 120 mg + PDR001 300 mg | EXPERIMENTAL | Participants received FGF401 120 mg in combination with PDR001 300 mg while fasted |
| Phase II: Group 1 - FGF401 120 mg QD | EXPERIMENTAL | Group 1 was comprised of HCC participants from Asian countries who received single agent FGF401 120 mg QD while fasted |
| Phase II: Group 2 - FGF401 120 mg QD | EXPERIMENTAL | Group 2 was comprised of HCC participants from non-Asian countries who took single agent FGF401 120 mg QD while fasted |
| Phase II: Group 3 - FGF401 120 mg QD | EXPERIMENTAL | Group 3 was comprised of participants with other solid malignancies regardless of geography who took single agent FGF401 120 mg QD while fasted |
| Name | Type | Description |
|---|---|---|
| FGF401 | DRUG | FGF401 is a FGFR4 inhibitor. |
| PDR001 | BIOLOGICAL | PDR001 is a humanized anti-PD1 IgG4 antibody that blocks the binding of PD-L1 and PD-L2 |
Inclusion Criteria: 1. ECOG Performance Status ≤ 1 2. Presence of at least one measurable lesion according to RECIST v1.1. c-i) FGF401 single agent-Phase I and Phase II, Group 3: Patients with HCC or advanced solid tumors, who have progressed despite standard therapy or are intolerant of standard t...