First-in-Human Study of LPM6690176 in Patients With Advanced Solid Tumors.

NCT06240546 | Recruiting Phase 1

• 1 other identifier: LY01024/CT-CHN-101
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a phase 1, first-in-human, open-label, dose-escalation and dose-expansion study designed to evaluate the safety and tolerability, pharmacokinetics characteristics and preliminary anti-tumor activity of LPM6690176 capsules in patients with advanced solid tumors.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (2)

• Number of dose-limiting toxicities (DLTs)

  From the first dose of study drug treatment through Cycle 1 (28 days)

• maximum tolerated dose (MTD) of LPM6690176

  From the first dose of study drug treatment through Cycle 1 (28 days)

Secondary Outcomes (9)

• Overall response rate (ORR)

  Approximately 2 years

• Duration of response (DOR)

  Approximately 2 years

• isease control rate (DCR)

  Approximately 2 years

• Progression-free survival (PFS)

  Approximately 2 years

• Overall survival (OS)

  Approximately 3 years

Study Arms (7)

2 mg/m2

EXPERIMENTAL

LPM6690176 capsules administered 2 mg/m2 on day 1-5 (qd) every two weeks.

Drug: LPM6690176

4 mg/m2

EXPERIMENTAL

LPM6690176 capsules administered 4 mg/m2 on day 1-5 (qd) every two weeks.

Drug: LPM6690176

8 mg/m2

EXPERIMENTAL

LPM6690176 capsules administered 8 mg/m2 on day 1-5 (qd) every two weeks.

Drug: LPM6690176

16 mg/m2

EXPERIMENTAL

LPM6690176 capsules administered 16 mg/m2 on day 1-5 (qd) every two weeks.

Drug: LPM6690176

24 mg/m2

EXPERIMENTAL

LPM6690176 capsules administered 24 mg/m2 on day 1-5 (qd) every two weeks.

Drug: LPM6690176

36 mg/m2

EXPERIMENTAL

LPM6690176 capsules administered 36 mg/m2 on day 1-5 (qd) every two weeks.

Drug: LPM6690176

48 mg/m2

EXPERIMENTAL

LPM6690176 capsules administered 48 mg/m2 on day 1-5 (qd) every two weeks.

Drug: LPM6690176

Interventions

LPM6690176 DRUG

Administered orally

Also known as: LY01024

16 mg/m2; 2 mg/m2; 24 mg/m2; 36 mg/m2; 4 mg/m2; 48 mg/m2; 8 mg/m2

Eligibility Criteria

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

You may qualify if:

• Able to provide a signed informed consent;
• Age 18 \~ 75 years, male or female;
• Patients with histologically or cytologically confirmed advanced or metastatic unresectable solid tumors, who failed or intolerant to standard anti-tumor therapy or lack of standard therapy;
• According to RECIST 1.1 criteria,
• Dose escalation phase: patients with at least one non-measurable lesion;
• Dose expansion phase: patients with at least one measurable lesion;
• Eastern Cooperative Oncology Group (ECOG) score of 0 or 1;
• Life expectancy≥ 3 months;
• Adequate bone marrow, liver, kidney, metabolism and coagulation function (blood transfusion, colony stimulating factors, albumin, and blood products are not allowed to use within 14 days before enrollment);
• Negative pregnancy test within 7 days before first dose of study drug treatment in women of childbearing age. Female patients with childbearing potential were to use effective contraception during and for 6 months after the first dose of study drug treatment. Male patients (female partners with childbearing potential) should take effective contraceptive measures during study drug treatment and until 4 months after last dose of study drug administration.

You may not qualify if:

• Patients who have not recovered from AEs caused by previous anti-tumor therapy to ≤ Grade 1 (assessed according to NCI-CTCAE 5.0 criteria, excluding alopecia and ≤ Grade 2 peripheral sensory neuropathy);
• Pleural effusion, pericardial effusion, or ascites requiring medical intervention or frequent drainage within 1 month before signed informed consent decided by the investigator;
• Symptomatic brain metastasis, history of spinal cord compression or leptomeningeal metastasis;
• Concomitant Diseases:
• Any of the following diseases within 6 months before the first dose of study treatment: myocardial infarction, unstable angina, coronary artery/peripheral artery bypass grafting, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, and serious arrhythmia requiring treatment;
• Patients who require long-term anticoagulant therapy or anti-platelet therapy or require long-term use of non-steroidal anti-inflammatory drugs;
• Patients with uncontrolled hypertension, hypertensive crisis or history of hypertensive encephalopathy;
• Patients with increased risk of gastrointestinal ulcer or gastrointestinal bleeding tendency or gastrointestinal perforation tendency;
• Patients with known active colitis within 8 weeks prior to screening, or diarrhea ≥4 times in 24 hours;
• Active infection requiring systemic antibacterial, antifungal, or antiviral therapy within 2 weeks before the first dose of study drug treatment;
• HBsAg (+) and HBV DNA≥ 1×103 or HCV (+) or HIV (+);
• Patients who have undergone major surgical procedures 4 weeks before the first dose of study drug treatment, or have severe injury, or requiring elective major surgery during the study, or have unhealed wounds, ulcers or fractures;
• Prior Medications:
• Patients who received anti-tumor therapy within 4 weeks before the first dose of study drug treatment;
• Received LPM6690176 capsules or other PLK-1 inhibitors therapy before enrollment;

Sponsors & Collaborators

• Luye Pharma Group Ltd.: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, China

RECRUITING

Study Officials

• Lin Shen, Doctor

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lin Shen, Doctor

CONTACT

0086-10-88121122; doctorshenlin@sina.cn

Study Design

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

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: February 5, 2024
• Study Start: March 12, 2024
• Primary Completion: February 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)