A Phase 1 Study of NM6603 in Advanced Solid Tumors (NCT06046066) | Clinical Trial Compass
TerminatedPhase 1
A Phase 1 Study of NM6603 in Advanced Solid Tumors
Stopped: Discontinuation based on a strategic sponsor decision, not driven by safety concerns.
United States17 participantsStarted 2023-08-31
Plain-language summary
This study is to assess the MTD and RP2D of NM6603 in adult patients with advanced solid tumors.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Have a histologically or cytologically confirmed diagnosis of advanced solid tumor;
✓. Have advanced or metastatic disease refractory to standard curative or palliative therapy or contraindication to standard therapy;
✓. Have objective (assessable through clinical signs, symptoms, and/or laboratory findings) and radiologically-confirmed progression of disease at Screening;
✓. Patients must have measurable disease based on RECIST v1.1;
✓. ≥ 18 years of age;
✓. Patients must exhibit a/an ECOG performance status of 0-2;
✓. Have a life expectancy of at least 12 weeks (in the opinion of the investigator);
✓. Have adequate bone marrow reserve:
Exclusion criteria
✕. Have unresolved toxicity from previous treatment or previous investigational agents, excluding alopecia. Clinical judgment by the investigator is allowed to determine if grade 1 fatigue at screening is residual toxicity from prior treatment or is a symptom of the patient's general condition or disease or if \> Grade 1 toxicities are non-clinically relevant such as Lymphopenia. The investigator and medical monitor will discuss the eligibility of patients with baseline toxicity;
✕. Have signs or symptoms of end organ failure, major chronic illnesses other than cancer, or any severe concomitant conditions which, in the opinion of the investigator, make it undesirable for the patient to participate in the study, or which could jeopardize compliance with the protocol;
What they're measuring
1
To determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) of NM6603 in patients with advanced solid tumors
✕. Have evidence of another malignancy not in remission or history of such a malignancy within the last three years (except for treated basal or squamous cell carcinoma of the skin, or in situ cancer of the cervix);
✕. Have abnormalities in the 12-lead ECG that in the opinion of the Investigator increase the risk of participating in the study (e.g., sinus rhythm with PR interval \> 240 ms or second degree or higher AV block, confirmed by a repeat ECG);
✕. Have ECG evidence of complete left bundle branch block or ventricular pacing;
✕. Have a history of long QT syndrome or prolonged QT interval corrected based on Fridericia's method (QTcF) \>450 ms at screening;
✕. Require treatment with drugs known to be associated with Torsade de Pointes;
✕. Have experienced any of the following within the 6-month period prior to screening that would interfere with the subject's participation in the opinion of the treating investigator: unstable angina, myocardial infarction or cerebrovascular accident, transient ischemic attack, cardiac failure with known ejection fraction less than 40%;