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An Open-Label, Phase 1 Study to Evaluate Safety, Tolerability and Pharmacokinetics of the CTPS1 Inhibitor STP938 in Adult Subjects with Advanced Solid Tumors, With a Safety Expansion in Advanced CTPS2 Null Ovarian Cancer
Cancer Categories
Brain and Nervous System,Gastrointestinal (GI),Genitourinary (GU),Gynecologic,Head and Neck,Lung,Skin
Karmanos Trial ID
2024-072
NCT ID
NCT06297525
Age Group
Adult
Scope
National
Phase
Phase I
Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.
Phase I
Principal Investigator
Ira
Winer, M.D., Ph.D., FACOG
Oncology - Gynecologic, Oncology - Surgical
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Objective:
Primary Objectives:
Evaluate the safety and tolerability of single agent STP938
To determine the RP2D for STP938.
Secondary Objectives:
Evaluate the PK of STP938
Evaluate the preliminary clinical activity of single agent STP938.
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NCI Dictionary of Cancer Terms
KCI Clinical Trials App
Eligibility
Locations
Applicable Disease Site
Therapies | Drugs | Devices
Eligibility
Eligibility
Main Inclusion Criteria:
Signed and dated informed consent, and able to comply with the study procedures and any locally required authorization.
Male or female aged ≥ 18 years.
Advanced disease not curable by available therapies and requires systemic therapy.
Histologically confirmed diagnosis of eligible cancer type.
Must have tumor tissue available for biomarker testing.
Measurable disease (Part 1) and measurable disease per RECIST (Part2)
Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
Life expectancy > 3 months as assessed by the Investigator.
Adequate organ function (bone marrow, hepatic, renal function and coagulation).
All toxicities (except alopecia) from prior cancer treatments or procedures must have resolved to ≤Grade 1 or returned to baseline levels prior to enrollment.
Main Exclusion Criteria:
Pregnant or breastfeeding females and women of childbearing potential or males unwilling to comply with contraception requirements.
Known active or symptomatic CNS metastases, carcinomatous meningitis, leptomeningeal disease or a history of spinal cord compression
Active malignancy within 2 years of study enrollment
Prior radiation within 2 weeks of start of therapy.
Systemic cancer treatments, monoclonal antibody-directed therapies, other investigational agents within 4 weeks before enrollment, or <5 half-lives since completion of previous investigational therapy, whichever is shorter.
Uncontrolled intercurrent illness.
Immunocompromised subjects with increased risk of opportunistic infections or history of opportunistic infection in the last 12 months.
Known active or chronic hepatitis B or active hepatitis C virus (HCV) infection.
Locations
Locations
Karmanos Cancer Institute - Detroit Headquarters
4100 John R
Detroit, MI 48201
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Phone:
1-800-527-6266
Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills
31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone:
1-800-527-6266
Applicable Disease Site
Applicable Disease Site
Brain and Nervous System; Colon; Esophagus; Kidney; Larynx; Lip, Oral Cavity and Pharynx; Liver; Lung; Melanoma, Skin; Other Female Genital; Other Respiratory and Intrathoracic Organs; Ovary; Pancreas; Prostate; Thyroid; Urinary Bladder
Therapies, Drugs, Devices
Therapies | Drugs | Devices
Therapies
Cellular Therapy
Drugs
STP938
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