MC# 23-01 - A Phase I Study of KSQ-4279 Alone and in Combination in Patients with Advanced Solid Tumors
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Agent(s): KSQ-4279
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Disease Type(s): Ovarian, Solid Tumor
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Phase(s): I
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Drug Classification(s): Small Molecule, Targeted Therapy
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Molecular Target(s): USP1
Mechanism of Action
small molecule inhibitor of USP1
Purpose
In this study, the sponsor and investigators want to learn:
- How much of KSQ-4279 can be given with an acceptable level of side effects alone and in combination with an oral PARP inhibitor or platinum-based chemotherapy
- The effects of KSQ-4279 (good and bad) alone and in combination with an oral PARP inhibitor or platinum-based chemotherapy
- How much of KSQ-4279 is absorbed into the blood and how fast it is removed
Inclusion Criteria
- Age 18 years or older
- Life expectancy of ≥ 12 weeks
- Measurable disease or non-measurable per RECIST v1.1 in dose escalation only; patients in dose expansion are required to have measurable disease per RECIST v1.1
- Recovered to ≤ Grade 1 or baseline toxicity (except alopecia) from prior therapy (per NCI-CTCAE v5.0)
- Eastern Cooperative Oncology Group performance status 0 or 1
- Adequate bone marrow and organ function at baseline
- Female patients who are women of childbearing potential with confirmed of a negative pregnancy test and agreement to the use of a highly effective contraceptive method or at least 2 effective methods at the same time during study treatment period and for up to 3 months after the last dose of study treatment. Male patients must be willing to use effective barrier contraception during the study treatment period and for up 3 months after the last dose of study treatment.
- Histologically or cytologically confirmed locally advanced (unresectable) or metastatic solid tumors who meet one of the following criteria (dose escalation only):
- Relapsed or progressed through standard therapy
- Have a disease for which no standard effective therapy exists
- Not a candidate for standard effective therapy
Exclusion Criteria
- Prior anticancer treatment including:
- Chemotherapy or small molecule-targeted therapy < 2 weeks prior to first dose of study treatment
- Any antibody therapy < 5 half-lives from first dose of study treatment (or 4 weeks since last therapy, whichever is the shortest)
- PD-1 (anti-programmed death 1) or PD-L1 (anti-programmed death ligand 1) therapy < 4 weeks from first dose of study treatment
- Invasive surgery requiring general anesthesia < 30 days from first dose of study treatment
- Chemotherapy with nitrosoureas or mitomycin C, < 45 days from first dose of study treatment
- Radiation therapy (including radiofrequency ablation) < 4 weeks prior to initiation of study treatment
- Grade 2 or greater toxicity, except alopecia related to any prior treatment (ie, chemotherapy, targeted therapy, radiation, or surgery)
- Prolongation of QT/QTc interval (QTc interval > 480 msec) using the Frederica method of QTc analysis
- Women who are pregnant or nursing
- Seropositive for human immunodeficiency virus (HIV) 1 or 2 or acquired immunodeficiency syndrome (AIDS) or active infection with hepatitis B virus or hepatitis C virus (HCV)
- 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 judgement of the Investigator, would make the patient inappropriate for the study
Location
- Dallas, TX - Mary Crowley Cancer Research - Medical City
