PHASE 1/2 STUDY OF TAS-120 IN PATIENTS WITH ADVANCED SOLID TUMORS HARBORING FGF/FGFR ABERRATIONS

Phase 2

Completed

• Conditions: Advanced solid tumors; 10027655

• Registration Number: NL-OMON48846
• Lead Sponsor: Taiho Oncology, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

1. Provide written informed consent., 2. Is >= 18 years (or according the
country's regulatory definition for legal adult age)., 3. Has histologically or
cytologically confirmed, locally advanced, metastatic cancer meeting the
following criteria:
a.Phase 1 Expansion , i.Patient has failed ((or in the case of Group
2, failed or refused) all standard therapies or standard therapy does not exist
or is not tolerated. , ii. Patient is eligible for 1 of the following
enrollment groups, based on diagnosis, prior therapy, and FGF/FGFR aberrations
as shown:
a. Group 1 (Enrollment Suspended as of Amendment 7): Patient has
intrahepatic or extrahepatic cholangiocarcinoma harboring FGFR2 gene fusions.
b. Group 2: Patient has intrahepatic or extrahepatic
cholangiocarcinoma withharboring FGFR2 gene fusions or other FGFR2 , and has
not received or received less than 1 cycle of prior chemotherapy (due to
intolerance or patient refusal).
c. Group 3 (Enrollment Suspended as of Amendment 7): Patient has
intrahepatic or extrahepatic cholangiocarcinoma harboring FGFR2 gene fusions
and has received prior treatment with FGFR inhibitors.
d. Group 4 (Enrollment suspended as of Amendment 7): Patient has
intrahepatic or extrahepatic cholangiocarcinoma harboring FGFR abnormalities,
other than FGFR2 gene fusions (for example, mutations, rearrangements, or
amplifications).
e. Group 5: Patient has a primary CNS tumor harboring FGFR gene fusion
or FGFR1 activating mutation and fulfills the following criteria (i and ii):,
i. Patients who are presenting in recurrence or relapse must have at least one
measurable enhancing mass lesion with 2 perpendicular diameters of at least 10
mm documented on baseline contrast magnetic resonance imaging (MRI)
(gadolinium-based MRI).
ii. Patients should be on a stable dose of steroids for at least
7 days prior to obtaining the baseline contrast MRI of the brain and at least 7
days prior to starting study drug. , f. Group 6 (Enrollment Suspended as of
Amendment 7): Patient has advanced urothelial carcinoma harboring FGFR3 fusions
or FGFR3 activating mutations.
g. Group 7: Patient has any tumor type not included in one of the prior
groups, harboring FGFR2 amplification (no minimum number of copies).
h. Group 8 (Enrollment Suspended as of Amendment 7): Patient has any
tumor type not included in one of the prior groups, harboring FGFR gene fusions
or activating mutations.
, b. Phase 2, i. Patient has histologically or cytologically confirmed,
locally advanced, metastatic, unresectable iCCA harboring FGFR2 gene fusions or
other FGFR2 rearrangements based on results from either of the following:
a. Testing by Foundation Medicine:
i. As part of study pre-screening; or
ii. Previously tested by Foundation Medicine; in this
case, it is requested that
tumor tissue be provided to Foundation Medicine if available.
b. Local laboratory testing using next generation sequencing [NGS],
fluorescence in situ
hybridization [FISH], or other assays that can determine FGFR2 gene fusions or
other
FGFR2 rearrangements on tumor tissues or from ctDNA. It is requested that
patients
enrolled on this basis provide tumor tissues to Foundation Medicine, if
available from
either archival samples or fresh tumor biopsy.
ii. Patient has been treated wi

Exclusion Criteria

1. History and/or current evidence of clinically significant non-tumor related
alteration of calcium-phosphorus homeostasis., 2. History and/or current
evidence of clinically significant ectopic mineralization/calcification. , 3.
History and/or current evidence of clinically significant retinal disorder
confirmed by retinal examination. , 4. History or current evidence of serious
uncontrolled ventricular arrhythmias.

5. Fridericia*s corrected QT interval (QTcF) > 470 ms on ECG conducted during
Screening.

6. Treatment with any of the following within the specified time frame prior to
the first dose of TAS-120:, a. Major surgery within the previous 4 weeks (the
surgical incision should be fully healed prior to the first dose of TAS 120).,
b. Radiotherapy for extended field within 4 weeks or limited field radiotherapy
within 2 weeks. , c. Patients with locoregional therapy, e.g., transarterial
chemoembolization (TACE), selective internal radiotherapy (SIRT) or ablation
within 4 weeks. , d. Any noninvestigational anticancer therapy within 3 weeks
or have not recovered from side effects of such therapy prior to TAS 120
administration (mitomycin within prior 5 weeks). , • Targeted therapy or
immunotherapy within 3 weeks or within 5 half-lives (whichever is shorter) , e.
Any investigational agent received within 5 half-lives of the drug or 4 weeks,
whichever is shorter. Concurrent participation in an observational study may be
allowed after review by the Sponsor*s Medical Monitor.
f. Patients with prior FGFR-directed therapy., 7. A serious illness or
medical condition(s) including, but not limited to, the following:, a. Known
brain metastasis (not including primary brain tumors) unless patient is
clinically stable for >= 1 month., b. Known acute systemic infection., c.
Myocardial infarction, severe/unstable angina, symptomatic congestive heart
failure (New York Heart Association [NYHA] Class III or IV (see Appendix D, New
York Heart Association [NYHA] Classification) within the previous 2 months; if
> 2 months, cardiac function must be within normal limits and the patient must
be free of cardiac-related symptoms., d. Chronic nausea, vomiting, or diarrhea
considered to be clinically significant in the opinion of the investigator., e.
Congenital long QT syndrome, or any known history of torsade de pointes, or
family history of unexplained sudden death. , f. Other severe acute or chronic
medical or psychiatric condition or laboratory abnormality that in the judgment
of the investigator would make the patient inappropriate for entry into this
study., 8. Patients with a history of another primary malignancy that is
currently clinically significant, and has potential for metastases or currently
requires active intervention (except for gonadotropin-releasing hormone (GnRH)
or luteinizing hormone-releasing hormone (LH-RH) agonists in prostate cancer or
adjuvant hormonal therapy in breast cancer)., 9. Pregnant or lactating female.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified