Phase
Condition
Pelvic Cancer
Neoplasms
Treatment
XL495
ADC cytotoxic agents
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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.
Study Design
Connect with a study center
Exelixis Clinical Site #4
Denver, Colorado 80218
United StatesSite Not Available
Exelixis Clinical Site #9
New Haven, Connecticut 06511
United StatesSite Not Available
Exelixis Clinical Site #8
Washington, District of Columbia 20007
United StatesSite Not Available
Exelixis Clinical Site #10
Jefferson, Louisiana 70121
United StatesSite Not Available
Exelixis Clinical Site #7
New York, New York 10029
United StatesSite Not Available
Exelixis Clinical SIte #2
Huntersville, North Carolina 28078
United StatesSite Not Available
Exelixis Clinical Site #3
Nashville, Tennessee 37203
United StatesSite Not Available
Exelixis Clinical Site #5
Nashville, Tennessee 37203
United StatesSite Not Available
Exelixis Clinical Site #1
Austin, Texas 78758
United StatesSite Not Available
Exelixis Clinical Site #6
Houston, Texas 77030
United StatesSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.