A Dose-escalation, Dose-finding, and Expansion Study of XL495 in Participants With Locally Advanced or Metastatic Solid Tumors
- Conditions
- Solid CancersSolid Tumor CancerSolid Tumor MalignancyUrothelial Cancer (Urinary Bladder, Ureters, or Renal Pelvis Cancer)Metastatic Solid TumorLocally Advanced Solid TumorUrothelial Cancer of Renal Pelvis
- Interventions
- Drug: ADC cytotoxic agents
- Registration Number
- NCT06630247
- Lead Sponsor
- Exelixis
- Brief Summary
The goal of this study is to obtain safety, tolerability, PK, and preliminary clinical antitumor activity for XL495 as a single agent and in combination with select cytotoxic agents in participants with locally advanced or metastatic tumors for whom life-prolonging therapies do not exist or available therapies are intolerable/no longer effective.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 124
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Expansion XL495 + ADC cytotoxic agents XL495 Group(s) of participants with urothelial cancer who will receive XL495 and ADC cytotoxic agents at the recommended dosage(s) of expansion (RDE \[s\]) determined during the dose-escalation and dose-finding stages. Dose Escalation XL495 XL495 Group(s) of participants with advanced metastatic tumors who will receive increasing doses of XL495. Dose Finding XL495 + ADC cytotoxic agents XL495 Group(s) of participants with advanced metastatic tumors who will receive XL495 and Antibody drug conjugate (ADC) cytotoxic agents together at increasing doses. Dose Finding XL495 + ADC cytotoxic agents ADC cytotoxic agents Group(s) of participants with advanced metastatic tumors who will receive XL495 and Antibody drug conjugate (ADC) cytotoxic agents together at increasing doses. Expansion XL495 + ADC cytotoxic agents ADC cytotoxic agents Group(s) of participants with urothelial cancer who will receive XL495 and ADC cytotoxic agents at the recommended dosage(s) of expansion (RDE \[s\]) determined during the dose-escalation and dose-finding stages.
- Primary Outcome Measures
Name Time Method Dose-escalation and Dose-finding Stages: Number of Participants with Treatment-Emergent Adverse Events Up to 18 months Dose-escalation and Dose-finding Stages: Number of Participants with Dose-limiting Toxicities Up to 18 months Expansion Stage: Number of Participants with Treatment-Emergent Adverse Events Up to 19 months Expansion Stage: Objective Response Rate (ORR) As Assessed by Investigator Per RECIST 1.1 Until disease progression or death, up to approximately 19 months ORR is defined as the percentage of participants with the best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), as assessed by the Investigator per RECIST 1.1.
- Secondary Outcome Measures
Name Time Method Dose-escalation and Dose-finding Stages: Concentration of XL495 in Plasma Pre-dose and multiple post-dose time points, up to 18 months Dose-escalation and Dose-finding Stages: Pharmacokinetic (PK) Parameter Area Under the Plasma Concentration Time Curve (AUC) of XL495 Pre-dose and multiple post-dose time points, up to 18 months Dose-escalation and Dose-finding Stages: PK Parameter Maximum Plasma Concentration of XL495 (Cmax) Pre-dose and multiple post-dose time points, up to 18 months Dose-escalation and Dose-finding Stages: PK Parameter Time to Cmax of XL495 (Tmax) Pre-dose and multiple post-dose time points, up to 18 months Dose-escalation and Dose-finding Stages: PK Parameter Apparent Clearance with Oral Administration of XL495 (CL/F) Pre-dose and multiple post-dose time points, up to 18 months Dose-escalation and Dose-finding Stages: PK Parameter Apparent Terminal Elimination Half-life of XL495 (t1/2) Pre-dose and multiple post-dose time points, up to 18 months Expansion Stage: Duration of Response (DOR) As Assessed by Investigator per RECIST 1.1 Until disease progression or death, up to approximately 19 months. DOR is defined as the time from the first documented objective response (CR or PR) until the earlier of radiographic progressive disease (PD) as assessed by the investigator per RECIST 1.1 or censoring due to lack of these events or start of non-protocol anti-cancer therapy.
Expansion Stage: Progression-free Survival (PFS), as Assessed by Investigator per RECIST 1.1 Until disease progression or death, up to approximately 19 months. PFS is defined as the time from start of study treatment to the earlier of either radiographic PD per RECIST 1.1 or death from any cause.
Expansion Stage: Concentration of XL495 in Plasma Pre-dose and multiple post-dose time points, up to 18 months Expansion Stage: Pharmacokinetic (PK) Parameter Area Under the Plasma Concentration Time Curve (AUC) of XL495 Pre-dose and multiple post-dose time points, up to 18 months Expansion Stage: PK Parameter Maximum Plasma Concentration of XL495 (Cmax) Pre-dose and multiple post-dose time points, up to 18 months Expansion Stage: PK Parameter Time to Cmax of XL495 (Tmax) Pre-dose and multiple post-dose time points, up to 18 months Expansion Stage: PK Parameter Apparent Clearance with Oral Administration of XL495 (CL/F) Pre-dose and multiple post-dose time points, up to 18 months Expansion Stage: PK Parameter Apparent Terminal Elimination Half-life of XL495 (t1/2) Pre-dose and multiple post-dose time points, up to 18 months
Trial Locations
- Locations (10)
Exelixis Clinical Site #10
🇺🇸Jefferson, Louisiana, United States
Exelixis Clinical Site #4
🇺🇸Denver, Colorado, United States
Exelixis Clinical Site #9
🇺🇸New Haven, Connecticut, United States
Exelixis Clinical Site #8
🇺🇸Washington, District of Columbia, United States
Exelixis Clinical Site #7
🇺🇸New York, New York, United States
Exelixis Clinical SIte #2
🇺🇸Huntersville, North Carolina, United States
Exelixis Clinical Site #3
🇺🇸Nashville, Tennessee, United States
Exelixis Clinical Site #5
🇺🇸Nashville, Tennessee, United States
Exelixis Clinical Site #1
🇺🇸Austin, Texas, United States
Exelixis Clinical Site #6
🇺🇸Houston, Texas, United States