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New treatment option for Advanced Solid Tumor
Official title A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT05932862
What this study is testing
What is XL309?
XL309 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for advanced solid tumor.
Also referred to as ISM3091.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Capable of understanding and complying with protocol requirements.
- Male or female aged 18 years or older.
- Eastern Cooperative Oncology Group performance status 0 or 1.
- Adequate bone marrow and organ function.
- Participant-disease Characteristics Dose-Escalation Stage Single Agent and Combination: a) Participants whose tumor progressed on, or who were...
You likely can't join if
- Prior anticancer treatment including:
- Small molecule-targeted therapy \< 5 half-lives from first dose of study treatment, or 3 weeks (whichever is shorter).
- Any antibody therapy \< 5 half-lives from first dose of study treatment (or 4 weeks since last therapy, whichever is shorter).
- Chemotherapy with nitrosoureas or mitomycin C \< 6 weeks from first dose of study treatment. Other chemotherapy \< 3 weeks prior to first dose of...
- Radiation therapy (including radiofrequency ablation) \< 1 week prior to initiation of study treatment. Participants with clinically relevant ongoing...
- Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for...
See the full eligibility criteria
- Capable of understanding and complying with protocol requirements.
- Male or female aged 18 years or older.
- Eastern Cooperative Oncology Group performance status 0 or 1.
- Adequate bone marrow and organ function.
- Participant-disease Characteristics Dose-Escalation Stage Single Agent and Combination: a) Participants whose tumor progressed on, or who were intolerant to standard therapy, have a disease for which no therapy exists...
- Participants in the Cohort-Expansion Stage must have at least 1 measurable target lesion.
- Recovery to baseline or ≤ Grade 1 CTCAE v5 from AE(s) related to any prior treatments. Key
- Prior anticancer treatment including:
- Small molecule-targeted therapy \< 5 half-lives from first dose of study treatment, or 3 weeks (whichever is shorter).
- Any antibody therapy \< 5 half-lives from first dose of study treatment (or 4 weeks since last therapy, whichever is shorter).
- 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.
- 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.
- 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.
- 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.
- Lactating or pregnant females.
- Clinically relevant cardiovascular disease.
- Known history of myelodysplastic syndrome.
- 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...
- Inability or unwillingness to comply with requirement for oral drug administration or presence of a gastrointestinal condition that would preclude adequate absorption of XL309.
- Prior treatment with a ubiquitin specific peptidase 1 (USP1) inhibitor.
The study team makes the final eligibility decision.
Where it's taking place
- Fountain Valley, California, United States
- Jacksonville, Florida, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- Rochester, Minnesota, United States
- Kansas City, Missouri, United States
- New Brunswick, New Jersey, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Oklahoma City, Oklahoma, United States
- Germantown, Tennessee, United States
- Nashville, Tennessee, United States
- Austin, Texas, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fountain Valley, California, United States; Jacksonville, Florida, United States; Orlando, Florida, United States; Tampa, Florida, United States; Rochester, Minnesota, United States; Kansas City, Missouri, United States and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.