Safety and Preliminary Anti-Tumor Activity of TYRA-300 in Advanced Urothelial Carcinoma and Other Solid Tumors With FGFR3 Gene Alterations
Safety and Preliminary Anti-Tumor Activity of TYRA-300 in Advanced Urothelial Carcinoma and Other Solid Tumors With FGFR3 Gene Alterations
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and
preliminary antitumor activity of TYRA-300 in cancers with FGFR3 activating gene alterations,
including locally advanced/metastatic urothelial carcinoma of the bladder and urinary tract
and other advanced solid tumors.
preliminary antitumor activity of TYRA-300 in cancers with FGFR3 activating gene alterations,
including locally advanced/metastatic urothelial carcinoma of the bladder and urinary tract
and other advanced solid tumors.
Not Available
Phase I/II
Adults
Not Available
Not Available
Berlin, Jordan
International
Vanderbilt University
07-06-2023
Eligibility
18 Years
BOTH
NO
Inclusion Criteria:
Inclusion Criteria: Phase 1 Part A and Part B - Men and women 18 years of age or older. - Eastern Cooperative Oncology Group (ECOG) performance status of 1. - Histologically confirmed advanced solid tumor who have exhausted standard therapeutic options. - Evaluable (Part A) or measurable (Part B) disease according to RECIST v1.1. - Histologically confirmed advanced solid tumor with an eligible FGFR3 gene mutation or fusion (Part B). Phase 2 - Men and women 12 years of age or older. - ECOG performance status of 0-2 or Karnofsky Performance Scale (KPS) >70 for participants aged 12 to 17 years. - At least 1 measurable lesion by RECIST v1.1. - Histologically confirmed locally advanced/metastatic tumor in one of the following categories: - Urothelial carcinoma with an eligible FGFR3 gene mutation or rearrangement who have progressed on a prior FGFR inhibitor and presence of a resistance mutation or other kinase domain mutation. - Urothelial carcinoma with an eligible FGFR3 gene mutation or rearrangement who has not received a prior FGFR inhibitor. - Any solid tumor with an eligible FGFR3 gene mutation or rearrangement. Exclusion Criteria (All Phases): - Has a serum phosphorus level > upper limit of normal (ULN) during screening that remains >ULN despite medical management. - Any ocular condition likely to increase the risk of eye toxicity. - History of or current uncontrolled cardiovascular disease. - Active, symptomatic, or untreated brain metastases. - Gastrointestinal disorders that will affect oral administration or absorption of TYRA-300. - Females who are pregnant, breastfeeding, or planning to become pregnant and males who plan to father a child while enrolled in this study.
Inclusion Criteria: Phase 1 Part A and Part B - Men and women 18 years of age or older. - Eastern Cooperative Oncology Group (ECOG) performance status of 1. - Histologically confirmed advanced solid tumor who have exhausted standard therapeutic options. - Evaluable (Part A) or measurable (Part B) disease according to RECIST v1.1. - Histologically confirmed advanced solid tumor with an eligible FGFR3 gene mutation or fusion (Part B). Phase 2 - Men and women 12 years of age or older. - ECOG performance status of 0-2 or Karnofsky Performance Scale (KPS) >70 for participants aged 12 to 17 years. - At least 1 measurable lesion by RECIST v1.1. - Histologically confirmed locally advanced/metastatic tumor in one of the following categories: - Urothelial carcinoma with an eligible FGFR3 gene mutation or rearrangement who have progressed on a prior FGFR inhibitor and presence of a resistance mutation or other kinase domain mutation. - Urothelial carcinoma with an eligible FGFR3 gene mutation or rearrangement who has not received a prior FGFR inhibitor. - Any solid tumor with an eligible FGFR3 gene mutation or rearrangement. Exclusion Criteria (All Phases): - Has a serum phosphorus level > upper limit of normal (ULN) during screening that remains >ULN despite medical management. - Any ocular condition likely to increase the risk of eye toxicity. - History of or current uncontrolled cardiovascular disease. - Active, symptomatic, or untreated brain metastases. - Gastrointestinal disorders that will affect oral administration or absorption of TYRA-300. - Females who are pregnant, breastfeeding, or planning to become pregnant and males who plan to father a child while enrolled in this study.
