Actively Recruiting
A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors
Led by Exelixis · Updated on 2025-09-05
429
Participants Needed
16
Research Sites
278 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a first-in-human (FIH), multicenter, open-label Phase I study to investigate the safety, tolerability, preliminary antitumor activity, as well as pharmacokinetics (PK) and pharmacodynamics of XL309 (previously ISM3091) administered alone or in combination with olaparib in participants with advanced solid tumors.
CONDITIONS
Official Title
A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and follow the study requirements
- Male or female aged 18 years or older
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Adequate bone marrow and organ function
- For dose escalation: advanced solid tumors with specific genetic alterations including HER2-negative breast cancer with BRCA1/2 alterations, high-grade serous ovarian cancer, castration-resistant prostate cancer with BRCA1/2 alterations, pancreatic cancer with BRCA1/2 alterations, or tumors with homologous recombination repair mutations or deficiency
- For cohort expansion: HER2-negative breast cancer with select HRR gene alterations; platinum-sensitive high-grade serous ovarian cancer with HRD or HRR gene alterations; metastatic castration-resistant prostate cancer with HRR gene alterations; or advanced solid tumors with HRR gene alterations
- At least one measurable target lesion for cohort expansion
- Recovery to baseline or grade 1 or less from adverse events related to prior treatments
You will not qualify if you...
- Prior anticancer treatments within specified washout periods: small molecule-targeted therapy less than 5 half-lives or 3 weeks, antibody therapy less than 5 half-lives or 4 weeks, chemotherapy with nitrosoureas or mitomycin C less than 6 weeks, other chemotherapy less than 3 weeks, radiation therapy less than 1 week before starting study treatment
- Known brain metastases or cranial epidural disease unless treated and stable for at least 4 weeks
- History of hypersensitivity to XL309 or similar drugs
- Pregnant or breastfeeding females
- Clinically relevant cardiovascular disease
- History of myelodysplastic syndrome
- Severe medical conditions or lab abnormalities that increase risk or interfere with study participation
- Inability or unwillingness to take oral drugs or gastrointestinal conditions preventing adequate absorption of XL309
- Prior treatment with a ubiquitin specific peptidase 1 (USP1) inhibitor
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 16 locations
1
Exelixis Clinical Site #12
Fountain Valley, California, United States, 92708
Withdrawn
2
Exelixis Clinical Site #15
Jacksonville, Florida, United States, 32224
Actively Recruiting
3
Exelixis Clinical Site #8
Orlando, Florida, United States, 32827
Actively Recruiting
4
Exelixis Clinical Site #16
Tampa, Florida, United States, 33612
Actively Recruiting
5
Exelixis Clinical Site #14
Rochester, Minnesota, United States, 55905
Actively Recruiting
6
Exelixis Clinical Site #10
Kansas City, Missouri, United States, 64111
Withdrawn
7
Exelixis Clinical Site #9
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
8
Exelixis Clinical Site #5
New York, New York, United States, 10029
Actively Recruiting
9
Exelixis Clinical Site #7
Cleveland, Ohio, United States, 44106
Actively Recruiting
10
Exelixis Clinical Site #13
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
11
Exelixis Clinical Site #11
Germantown, Tennessee, United States, 38138
Actively Recruiting
12
Exelixis Clinical Site #6
Nashville, Tennessee, United States, 37203
Actively Recruiting
13
Exelixis Clinical Site #4
Austin, Texas, United States, 78758
Actively Recruiting
14
Exelixis Clinical Site #1
Houston, Texas, United States, 77030
Actively Recruiting
15
Exelixis Clinical Site #2
Houston, Texas, United States, 77030
Withdrawn
16
Exelixis Clinical Site #3
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
E
Exelixis Clinical Trials
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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