A Phase 1 Study of NM6603 in Advanced Solid Tumors

NCT06046066 | Terminated Phase 1 FDA Drug

• 1 other identifier: NM6603-CP-101
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Cancers

Keywords

advanced solid tumors

Outcome Measures

Primary Outcomes (1)

• To determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) of NM6603 in patients with advanced solid tumors

  28 days

Secondary Outcomes (9)

• Efficacy of NM6603 by Objective Response Rate (ORR) via iRECIST

  From first dose of study drug to up to ~ 12 months in absence of progressive disease or unacceptable toxicity or withdrawal of consent

• Efficacy of NM6603 by disease control rate (DCR) via iRECIST

  From first dose of study drug to up to ~ 12 months in absence of progressive disease or unacceptable toxicity or withdrawal of consent

• Pharmacokinetics (PK) of NM6603 by maximum observed plasma drug concentration (Cmax)

  28 days

• Pharmacokinetics (PK) of NM6603 by apparent terminal elimination half-life (t1/2)

  28 days

• Pharmacokinetics (PK) of NM6603 by time to maximum observed plasma drug concentration (Tmax)

  28 days

Study Arms (1)

Dose Escalation

EXPERIMENTAL

NM6603, administered orally every day in 28-day cycles

Drug: NM6603

Interventions

NM6603 DRUG

NM6603 is an orally available investigational small molecule indicated for the treatment of solid malignancies including, but not limited to breast, liver, pancreatic, colorectal, cervical, melanoma and lung cancers.

Dose Escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

You may not qualify if:

• 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;
• 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%;
• Have other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that would make the patient inappropriate for enrollment in this study;
• Have any mental or medical condition that prevents the subject from giving informed consent or participating in the trial;
• Have received anti-tumor therapies such as chemotherapy, hormone therapy, radiation therapy, or immunotherapy within 4 weeks or 4 half-lives (whichever is shorter or as agreed between the site PI and Medical Monitor) prior to starting the study drug;
• Have received systemic corticosteroids (either oral or intravenous steroids, excluding inhalers or topicals) for a duration ≥ 4 weeks at the daily dose equivalent to ≥7.5 mg of oral prednisone within the 12 weeks prior to starting study drug;
• Are currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 28 days or four half-lives (whichever is shorter, or as agreed between the site PI and Medical Monitor) prior to first study drug administration;
• Have known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Note: Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability;
• Require treatment with strong inhibitors, strong inducers, and/or sensitive substrates of CYP1A2 and/or CYP3A4, and/or sensitive substrates of CYP2B6 or major drug transporters; This medication can be stopped and the patient enrolled after 4 half- lives of that drug, as determined by the PI.

Sponsors & Collaborators

• NucMito Pharmaceuticals Co. Ltd.: lead

Study Sites (4)

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Tennessee Oncology, PLLC

Nashville, Tennessee, 73203, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: September 21, 2023
• Study Start: August 31, 2023
• Primary Completion: April 25, 2025
• Study Completion: April 25, 2025
• Last Updated: May 7, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)