A Phase 1 Study of KSQ-4279 Alone and in Combination in Patients with Advanced Solid Tumors

Cancer Categories

Karmanos Trial ID

NCT ID

Age Group

Scope

Phase

Principal Investigator

Ira
Winer, M.D., Ph.D., FACOG
Oncology - Gynecologic, Oncology - Surgical View Profile

Primary Objective:

Determine the maximum tolerated dose
(MTD) and the recommended Phase 2
dose (RP2D) of KSQ-4279 alone and in
combination in patients with advanced
solid tumors

Secondary Objectives:

Assess the safety and tolerability of
KSQ-4279 alone and in combination in
patients with advanced solid tumors
Characterize the PK profile of KSQ-
4279 alone and in combination in
patients with advanced solid tumors
Evaluate preliminary antitumor activity
of KSQ-4279 alone and in combination
in patients with advanced solid tumors

Eligibility

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):

Exclusion Criteria:

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

Locations

4100 John R
Detroit, MI 48201
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Phone: 800-527-6266

31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone: 800-527-6266

Applicable Disease Site

Therapies, Drugs, Devices