A Phase 1 Study of NM6603 in Advanced Solid Tumors

Stopped early · Phase 1

Conditions studied: Cancers

In brief

This study is to assess the MTD and RP2D of NM6603 in adult patients with advanced solid tumors.

Key facts

Study ID: NCT06046066
Run by: NucMito Pharmaceuticals Co. Ltd.
People needed: 17
Starts: 2023-08-31
Expected to finish: 2025-04-25
Last updated by the study team: 2026-05-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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:
Absolute neutrophil count ≥1.5×109 cell/L;
Platelet count ≥100×109 cell/L;
Hemoglobin at least ≥9.0 g/dL
Have adequate liver function:
Total serum bilirubin ≤ 1.5× upper limit of normal (ULN);
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5× ULN or ≤5.0× ULN in case of documented hepatic metastasis;
Alkaline phosphatase ≤ 5× ULN
Have adequate renal function:
glomerular filtration rate ≥60 mL/min (calculated according to the formula of Cockcroft and Gault);
No clinically relevant abnormalities in the urinalysis results
Are capable of swallowing study medication and following directions regarding taking study drug;
Women of childbearing potential (WOCBP) and Women of non-childbearing potential are eligible to participate. Both women of childbearing potential and women of non-childbearing potential should use an approved method of birth control and agrees to continue to use this method for the duration of the study and for 90 days after taking the last dose of study drug.
Acceptable methods of contraception include abstinence, female subject/partner's use of hormonal contraceptive (oral, implanted, or injected) in conjunction with a barrier method (WOCBP only) (e.g., diaphragm, cervical cap, male condom, and female condom and spermicidal foam, sponges, and film), female subject/partner's use of an intrauterine device (IUD), or if the female subject/partner is surgically sterile (e.g., bilateral tubal ligation, hysterectomy) for at least 3 months before screening or two years postmenopausal at time of screening. All male subjects/partners (excluding men who have been sterilized) must agree to consistently and correctly use a condom for the duration of the study and for 90 days after taking the study drug. In addition, subjects may not donate sperm for the duration of the study and for 90 days after taking study drug.
Note: Women of non-childbearing potential who are less than two years postmenopausal should be tested for pregnancy. Any verbal confirmation of postmenopausal status will be recorded in source documents and appropriate page of CRF.
WOCBP must have a negative serum pregnancy test at Screening Visit and negative urine pregnancy test prior to receiving the first dose of study drug; and
Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on study.
Exclusion Criteria: Subjects meeting any of the following criteria will be excluded from enrollment:

Where it is running

Karmanos Cancer Institute — Detroit, Michigan, United States
Cleveland Clinic Taussig Cancer Center — Cleveland, Ohio, United States
Tennessee Oncology, PLLC — Nashville, Tennessee, United States
MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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