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Trial Title:
A Dose-escalation, Dose-finding, and Expansion Study of XL495 in Participants With Locally Advanced or Metastatic Solid Tumors
NCT ID:
NCT06630247
Condition:
Solid Cancers
Solid Tumor Cancer
Solid Tumor Malignancy
Urothelial Cancer (Urinary Bladder, Ureters, or Renal Pelvis Cancer)
Metastatic Solid Tumor
Locally Advanced Solid Tumor
Urothelial Cancer of Renal Pelvis
Conditions: Official terms:
Neoplasms
Pelvic Neoplasms
Conditions: Keywords:
solid tumor
renal tumor
metastatic solid tumor
urothelial carcinoma
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Intervention model description:
This study is divided into three stages:
The first stage is the dose escalation stage that evaluates how much of XL495 alone
patients can safely tolerate.
The second is the dose finding stage that evaluates how much of XL495 to give patients in
combination with other anti-cancer medications.
The third stage is the expansion stage that evaluates how XL495 performs in patients in
combination with other anti-cancer medications.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
XL495
Description:
oral doses of XL495
Arm group label:
Dose Escalation XL495
Arm group label:
Dose Finding XL495 + ADC cytotoxic agents
Arm group label:
Expansion XL495 + ADC cytotoxic agents
Intervention type:
Drug
Intervention name:
ADC cytotoxic agents
Description:
intravenous infusion of anti-cancer combination agent
Arm group label:
Dose Finding XL495 + ADC cytotoxic agents
Arm group label:
Expansion XL495 + ADC cytotoxic agents
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria
- For All Participants
- Have received at least one standard therapy unless it does not exist, or
available therapies are intolerable or no longer effective.
- For participants, who qualify for approved molecularly selected therapies such
as RAS inhibitors, they must have progressed on, relapsed from, been intolerant
to, ineligible, or refused those therapies.
- Expansion Stage
- Diagnosis of metastatic advanced UC (primary tumor: renal pelvis, ureter,
urinary bladder, or urethra).
- At least one measurable lesion as defined by RECIST, version 1.1.
- Participants must be eligible for sacituzumab govitecan treatment as their next
line of therapy.
- At least one but no more than 3 prior lines of therapy.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (0-2 for monotherapy;
0-1 for combo)
Exclusion Criteria
- Prior anticancer treatment, including:
- Radiation therapy within 2 weeks before first dose of study treatment.
- Known brain metastases or cranial epidural disease
- Current or recent severe illness
- Known history or positive test for human immunodeficiency virus (HIV) unless meets
specific criteria.
- Active infection with hepatitis B virus or hepatitis C virus.
- Malabsorption syndrome.
- History of solid organ, autologous or allogenic stem cell transplant.
- Diagnosis of another cancer within 2 years before first dose of study treatment,
except for superficial skin cancers, or localized, low-grade tumors deemed cured and
not treated with standard therapy.
- Active autoimmune disease with skin involvement.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Exelixis Clinical SIte #2
Address:
City:
Huntersville
Zip:
28078
Country:
United States
Status:
Recruiting
Facility:
Name:
Exelixis Clinical Site #1
Address:
City:
Austin
Zip:
78758
Country:
United States
Status:
Recruiting
Start date:
October 2024
Completion date:
November 2027
Lead sponsor:
Agency:
Exelixis
Agency class:
Industry
Source:
Exelixis
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06630247
