Safety and Pharmacokinetics of NM6603 in Chinese Patients With Advanced Solid Tumors

NCT07292038 | Recruiting Phase 1

• 1 other identifier: NM6603-CN-101
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Cancers

Keywords

advanced solid tumors

Outcome Measures

Primary Outcomes (2)

• maximum tolerated dose (MTD)

  MTD was defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients. DLT will be defined as toxicities that meet pre-defined severity criteria(according to the NCI CTCAE v5.0 toxicity assessment criteria), and assessed as having a suspected relationship to study drug that occurred within the first cycle(28 days) of treatment.

  During the first cycle. Each cycle is 28 days

• Recommended Phase II Dose

  The recommended dosage for subsequent Phase II studies will be based on MTD (Maximum Tolerant Dose), pharmacokinetics, preliminary efficacy and safety data from the study

  Up to 1 Year

Secondary Outcomes (9)

• Maximum observed concentration (Cmax) of NM6603

  Up to 31 days

• Time of maximum observed concentration (Tmax) of NM6603

  Up to 31 days

• Terminal elimination half-life (t1/2) of NM6603

  Up to 31 days

• Area under the curve from the time of dosing to the time of the last measurable concentration (AUClast) of NM6603

  Up to 31 days

• Area under the curve from the time of dosing to infinity (AUCinf) of NM6603

  Up to 31 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 administered investigational small-molecule drug evaluated in this dose-escalation study in patients with advanced solid tumors.

Dose Escalation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Advanced solid tumors (primarily advanced colorectal cancer or triple-negative breast cancer) confirmed by histology or cytology
• Prior adequate standard therapy with documented progression or intolerance, or lack of available standard therapy options, or contraindications to standard therapy
• At least one evaluable tumor lesion per RECIST version 1.1
• Age 18 to 75 years at the time of informed consent
• Body weight 45 kg or greater for men and 40 kg or greater for women
• ECOG performance status 0 or 1
• Expected survival time greater than 12 weeks
• Adequate organ and bone marrow function as defined below:
• Absolute neutrophil count 1500 per mm3 or greater
• Platelet count 100000 per mm3 or greater with no transfusion or growth factor use within 14 days before first dose
• Hemoglobin 9.0 g/dL or greater with no transfusion or stimulating factors within 14 days before first dose
• Total bilirubin 1.5 times upper limit of normal (ULN) or less (patients with Gilbert syndrome allowed)
• AST and ALT 2.5 times ULN or less without liver metastasis, or 5 times ULN or less with liver metastasis
• Creatinine clearance 60 mL/min or greater (Cockcroft-Gault formula)
• INR 1.5 times ULN or less and APTT 1.5 times ULN or less

You may not qualify if:

• Known hypersensitivity to NM6603 or its components
• Prior treatment with a drug targeting the same mechanism of action or molecular target
• Participation in another drug or device clinical trial within 4 weeks before first dose
• Major surgery within 4 weeks before first dose or planned surgery during the study
• Chemotherapy, biologic therapy, macromolecular targeted therapy, or radiotherapy within 4 weeks before first dose
• Oral fluoropyrimidines or other small molecule targeted agents received within 2 weeks or 5 half-lives before first dose (whichever is longer)
• Use of traditional Chinese medicine or herbal products with antitumor activity within 2 weeks before first dose
• Use of medications known to prolong QT interval or strong inhibitors or inducers of CYP1A2, CYP2A6, or CYP3A4 within 7 days before first dose, or requirement for continued use
• Systemic corticosteroids or immunosuppressive drugs at doses greater than 10 mg/day prednisone or equivalent within 4 weeks before first dose (physiologic replacement and topical/inhaled forms allowed)
• History of another malignancy within 5 years except for curatively treated carcinoma in situ of the cervix, non-melanoma skin cancer, localized prostate cancer, or ductal carcinoma in situ
• Active central nervous system metastases, including symptomatic brain metastases, leptomeningeal disease, spinal cord compression, or unstable brain metastasis
• Treated brain metastases allowed if stable for 4 weeks or longer, no neurologic symptoms, and not receiving systemic corticosteroids above replacement dose for 4 weeks
• Untreated asymptomatic brain metastases 1.5 cm or smaller allowed if not requiring corticosteroids
• Uncontrolled disease including:
• Active infection

Sponsors & Collaborators

• NucMito Pharmaceuticals Co. Ltd.: lead

Study Sites (3)

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361001, China

RECRUITING

Sun Yat-sen University Cancer Center (SYSUCC)

Guangzhou, Guangdong, 510060, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

COO

CONTACT

86-592-7829029; ClinicalDevelopment@nucmito.com

Study Design

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

Model Details: Participants are enrolled in sequential dose-escalation cohorts using a traditional 3+3 design, in which each cohort receives an escalating dose of NM6603.

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 18, 2025
• Study Start: December 18, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)