Brief Title: KIN-3248 in Participants With Advanced Tumors Harboring FGFR2 and//or FGFR3 Gene Alterations

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Part A (dose escalation) - incidence of dose limiting toxicities (DLTs)

Primary Outcome 1 - Timeframe: Initiation of study drug through 28 days

Primary Outcome 2 - Measure: Part A (dose escalation) - incidence of adverse events (AEs)

Primary Outcome 2 - Timeframe: Initiation of study drug through 28 days after last dose (up to approximately 18 months)

Primary Outcome 3 - Measure: Part B (dose expansion) - objective response rate (ORR): the proportion of participants who have achieved partial response (PR) or complete response (CR) according to RECIST v1.1

Primary Outcome 3 - Timeframe: Initiation of study drug until disease progression (up to approximately 36 months)

Primary Outcome 4 - Measure: Part B (dose expansion) - disease control rate (DCR): the proportion of participants who achieve stable disease, PR, or CR

Primary Outcome 4 - Timeframe: Initiation of study drug until disease progression (up to approximately 36 months)

Primary Outcome 5 - Measure: Part B (dose expansion) - duration of response (DOR): the length of time between initial tumor response to documented tumor progression

Primary Outcome 5 - Timeframe: Initiation of study drug until disease progression (up to approximately 36 months)

Primary Outcome 6 - Measure: Part B (dose expansion) - progression-free survival (PFS): the length of time until documented tumor progression

Primary Outcome 6 - Timeframe: Initiation of study drug until disease progression (up to approximately 36 months)

CONDITION

• Solid Tumor
• Adult
• Intrahepatic Cholangiocarcinoma
• Urothelial Carcinoma

ELIGIBILITY

Inclusion Criteria:
Provide written informed consent prior to initiation of any study-specific procedures

- Advanced stage solid tumor

- Known FGFR2 and/or FGFR3 gene alteration, as confirmed by previous genomic analysis of tumor tissue or ctDNA

- Measurable or evaluable disease according to RECIST v1.1

- ECOG performance status 0 or 1

- Adequate organ function, as measured by laboratory values (criteria listed in protocol)

- Able to swallow, retain, and absorb oral medications
Exclusion Criteria:
Known clinically-active or clinically-progressive brain metastases from non-brain tumors

- History and/or current evidence of abnormal calcium-phosphorous homeostasis, ectopic mineralization or calcification, or corneal or retinal disorder/keratopathy

- GI tract disease causing an inability to take oral medication, malabsorption syndrome, requirement for intravenous alimentation, or uncontrolled inflammatory GI disease

- Active, uncontrolled bacterial, fungal, or viral infection

- Women who are lactating or breastfeeding, or pregnant

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: N/A

Phone: N/A

Email: clinicaltrials@kinnate.com

LOCATION