Safety, Tolerability and Pharmacokinetics Study of QLH11906 in Patients With Advanced Solid Tumors Harboring MAPK Pathway Alterations.

NCT ID: NCT05488821

Last Updated: 2022-08-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-14
• Study Completion Date: 2025-07-01

Brief Summary

This is an open label, phase 1 clinical study to evaluate the safety and tolerability of different doses of QLH11906 monotherapy in patients with relapsed/refractory, unresectable locally advanced or metastatic advanced solid tumors with abnormal MAPK pathway, and determine the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD, if MTD cannot be determined) and Recommended Dose in Phase II Clinical Studies (Recommended Phase II Dose, RP2D).

Conditions

Advanced Solid Tumors Harboring MAPK Pathway Alterations

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

QLH11906

QLH11906 Tablets

Group Type: EXPERIMENTAL

QLH11906

Intervention Type: DRUG

QLH11906 only

Interventions

QLH11906

QLH11906 only

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. The subjects participated voluntarily, signed the informed consent, and were able to abide by the research procedures.

2. Subjects with advanced (metastatic or unresectable) solid tumors with histologically confirmed MAPK signaling pathway alteration.

3. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.

4. Subjects are able to swallow and retain oral medication without any clinically significant gastrointestinal abnormalities that alter absorption.

5. Subjects (including women and men) agree to use effective contraception for contraception from the time of signing the informed consent form to 180 days after the last use of the study drug. Female subjects of childbearing age cannot be pregnant or breastfeeding.

Exclusion Criteria

1. Subjects received systemic anticancer therapy within 2 weeks prior to the first dose.

2. Subjects received radical radiotherapy within 4 weeks before the first administration, or received local palliative radiotherapy for bone metastases within 1 week.

3. Subjects who have received inhibitors or inducers of CYP3A4 within 1 week before the first dose; or within 5 half-lives of the drug; or subjects who need to continue to receive these drugs during the study period.

4. Active bacterial, fungal, or viral infection requiring systemic therapy within 1 week prior to the first dose.

5. Subjects with symptomatic central nervous system (CNS) metastases and/or cancerous meningitis.

6. Cardiovascular and cerebrovascular diseases with clinical significance.

7. Clinically uncontrollable serous effusion (eg, pleural effusion that cannot be controlled by drainage or other methods).

8. Active gastrointestinal disease or other conditions that significantly interfere with drug absorption.

9. Known immediate or delayed hypersensitivity reactions or idiosyncratic reactions to the investigational treatment-related chemotherapeutic drugs and their excipients.

10. Human immunodeficiency virus (HIV) positive test result and Treponema pallidum antibody positive.

11. Hepatitis B virus surface antigen (HBsAg) positive and viral deoxyribonucleic acid (HBV DNA) > 2000 IU/ml or 104 copies/ml (only the centers that can perform qualitative examination, the HBV DNA test result is positive or high detection limit); hepatitis C virus antibody positive and viral ribonucleic acid (HCV RNA) positive.

12. Other malignant tumors occurred within 2 years before study enrollment. (Except: Bowen's disease; cured basal cell or squamous cell skin cancer; prostate cancer with a Gleason score of 6; treated cervical carcinoma in situ.)

13. Pregnant or lactating women.

14. Any pre-existing serious or unstable disease (except for the above-mentioned malignant tumors), mental disease or any disease or medical condition that the investigator considers may interfere with the subject's safety, obtaining informed consent, or complying with research procedures.

15. Concurrent participation in other clinical trials using experimental therapies.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qilu Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shandong Cancer Hospital

Shandong, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Lianghua Fang

Role: CONTACT

lianghua.fang@qilu-pharma.com

86-13645192882

Facility Contacts

Jinming Yu, MD,PhD

Role: primary

sdyujinming@126.com

0531-67626971

Other Identifiers

QLH11906-101

Identifier Type: -

Identifier Source: org_study_id