RECRUITING

A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

An Open-Label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of XL309 (ISM3091) as Single-Agent and Combination Therapy in Patients With Advanced Solid Tumors

Quick Facts

Study Start:2024-04-03
Study Completion:2029-08-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05932862

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Capable of understanding and complying with protocol requirements.
  2. 2. Male or female aged 18 years or older.
  3. 3. Eastern Cooperative Oncology Group performance status 0 or 1.
  4. 4. Adequate bone marrow and organ function.
  5. 5. Participant-disease Characteristics
  6. 6. Participants in the Cohort-Expansion Stage must have at least 1 measurable target lesion.
  7. 7. Recovery to baseline or ≤ Grade 1 CTCAE v5 from AE(s) related to any prior treatments.
  8. 1. Prior anticancer treatment including:
  9. 1. Small molecule-targeted therapy \< 5 half-lives from first dose of study treatment, or 3 weeks (whichever is shorter).
  10. 2. Any antibody therapy \< 5 half-lives from first dose of study treatment (or 4 weeks since last therapy, whichever is shorter).
  11. 3. Chemotherapy with nitrosoureas or mitomycin C \< 6 weeks from first dose of study treatment. Other chemotherapy \< 3 weeks prior to first dose of study treatment.
  12. 4. Radiation therapy (including radiofrequency ablation) \< 1 week prior to initiation of study treatment. Participants with clinically relevant ongoing complications from prior radiation therapy are not eligible.
  13. 2. Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks before first dose of study treatment.
  14. 3. History of hypersensitivity to any excipient of XL309, or history of allergic reactions attributed to drugs with a similar chemical or biologic structure or class to XL309.
  15. 4. Lactating or pregnant females.
  16. 5. Clinically relevant cardiovascular disease.
  17. 6. Known history of myelodysplastic syndrome.
  18. 7. Other severe, acute, or chronic medical condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or that may interfere with the interpretation of the study results, and in the judgment of the investigator, would make the participant inappropriate for the study.
  19. 8. Inability or unwillingness to comply with requirement for oral drug administration or presence of a gastrointestinal condition that would preclude adequate absorption of XL309.
  20. 9. Prior treatment with a ubiquitin specific peptidase 1 (USP1) inhibitor.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Exelixis Clinical Trials
CONTACT
1-888-393-5494)
druginfo@exelixis.com

Study Locations (Sites)

Exelixis Clinical Site #12
Fountain Valley, California, 92708
United States
Exelixis Clinical Site #15
Jacksonville, Florida, 32224
United States
Exelixis Clinical Site #8
Orlando, Florida, 32827
United States
Exelixis Clinical Site #16
Tampa, Florida, 33612
United States
Exelixis Clinical Site #14
Rochester, Minnesota, 55905
United States
Exelixis Clinical Site #10
Kansas City, Missouri, 64111
United States
Exelixis Clinical Site #9
New Brunswick, New Jersey, 08901
United States
Exelixis Clinical Site #5
New York, New York, 10029
United States
Exelixis Clinical Site #7
Cleveland, Ohio, 44106
United States
Exelixis Clinical Site #13
Oklahoma City, Oklahoma, 73104
United States
Exelixis Clinical Site #11
Germantown, Tennessee, 38138
United States
Exelixis Clinical Site #6
Nashville, Tennessee, 37203
United States
Exelixis Clinical Site #4
Austin, Texas, 78758
United States
Exelixis Clinical Site #1
Houston, Texas, 77030
United States
Exelixis Clinical Site #2
Houston, Texas, 77030
United States
Exelixis Clinical Site #3
San Antonio, Texas, 78229
United States

Collaborators and Investigators

Sponsor: Exelixis

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-03
Study Completion Date2029-08-03

Study Record Updates

Study Start Date2024-04-03
Study Completion Date2029-08-03

Terms related to this study

Keywords Provided by Researchers

  • Ovarian Cancer
  • Prostate Cancer
  • Pancreatic Cancer
  • Advanced HRRm Solid Tumors
  • Breast Cancer

Additional Relevant MeSH Terms

  • Advanced Solid Tumor