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CancersPhase 1NCT06046066

A Phase 1 Study of NM6603 in Advanced Solid Tumors

A Phase 1 study testing NM6603 in people with Cancers, run by NucMito Pharmaceuticals Co. Ltd. at 4 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancers
What is being tested?
NM6603
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
4 sitesUnited States
Study dates
31 Aug 2023to 25 Apr 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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:
  • 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.
  • Are unwilling to or unable to comply with the requirement of the protocol; and
  • Are pregnant or breastfeeding or expecting to conceive or have children within the projected duration of the trial, starting with the pre-screening or screening visit through the duration of study participation.

Who cannot join

None listed.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 73203

Other trials in United States

About this study

Official title: A Phase I Study to Determine the Maximum Tolerated Dose and Evaluate Safety, Tolerability, and Pharmacokinetics of NM6603 in Patients With Advanced Solid Tumors

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

Read the detailed description

This is a Phase 1, first-in-human, multicenter, open label, 3+3 dose escalation study designed to evaluate the safety profile, the maximum tolerated dose (MTD), the recommended Phase 2 dose (RP2D), the pharmacokinetic and the preliminary antitumor activity of NM6603 in patients with advanced solid tumors. The study has two parts. In Part 1, NM6603 will be administered once daily. In Part 2, NM6603 will be administered twice daily to explore the effect of twice daily dosing on the pharmacokinetic, safety and tolerability, and anti-tumor activity profile of NM6603,

Conditions
Cancers
Being tested
NM6603
Keywords
advanced solid tumors
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NM6603Drug

    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.

Study groups in NCT06046066
Study groupRoleWhat they receive
Dose EscalationExperimentalNM6603, administered orally every day in 28-day cycles
Receives: Drug: NM6603

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 28 days

Secondary outcomes (9)

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

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

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

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

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

    Measured: 28 days

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

    Measured: 28 days

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

    Measured: 28 days

  6. Pharmacokinetics (PK) of NM6603 by area under the plasma drug concentration-time curve (AUC) from time 0 to the time of the last quantifiable concentration (Tlast) (AUC0-t)

    Measured: 28 days

  7. Pharmacokinetics (PK) of NM6603 by AUC from time 0 to infinity (AUC0-∞)

    Measured: 28 days

  8. Safety of NM6603 by Dose-Limiting Toxicities

    Measured: 28 days

  9. Safety of NM6603 by incidence and severity of treatment-emergent adverse events (TEAEs)

    The intensity of the event will be graded using CTCAE v5.0 criteria.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2023
  2. Study start31 Aug 2023
  3. Primary completion25 Apr 2025
  4. Study completion25 Apr 2025

Why it stopped: Discontinuation based on a strategic sponsor decision, not driven by safety concerns.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06046066
Sponsor's protocol ID
NM6603-CP-101
Status last verified
Mar 2025
First submitted
5 Sep 2023
Last updated
7 May 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NM6603 in people with Cancers, run by NucMito Pharmaceuticals Co. Ltd. at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 42 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Discontinuation based on a strategic sponsor decision, not driven by safety concerns.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) of NM6603 in patients with advanced solid tumors (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06046066.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.

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