A Study of KC1036 in Patients with Advanced Solid Tumors

NCT ID: NCT04387916

Last Updated: 2024-10-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 207 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-04
• Study Completion Date: 2025-12-31

Brief Summary

The purpose of this study is to evaluate the safety，tolerability, pharmacokinetics, and preliminary efficacy of KC1036 in participants with advanced recurrent or metastatic solid tumors. The trial will be divided into three parts: dose-escalation phase, dose-expansion phase, RP2D-extension phase.

Conditions

Advanced Solid Tumors

Study Design

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

Study Groups

KC1036

Patients take a single dose of KC1036 for the pharmacokinetic study, then off for 5 days before the first cycle begins. In the subsequent treatment cycles, KC1036 are given orally once daily, 21 days as a cycle.

Group Type: EXPERIMENTAL

KC1036

Intervention Type: DRUG

Part 1: Dose-escalation phase , KC1036 10mg\~80mg, consists of 5 Cohorts. Part 2: Dose-expansion phase, consists of 3\~4 Cohorts based on part 1. Part 3:RP2D-extension phase, Recommended dose of KC1036 based on part 1and part 2.

Interventions

KC1036

Part 1: Dose-escalation phase , KC1036 10mg\~80mg, consists of 5 Cohorts. Part 2: Dose-expansion phase, consists of 3\~4 Cohorts based on part 1. Part 3:RP2D-extension phase, Recommended dose of KC1036 based on part 1and part 2.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Histologically or cytologically confirmed recurrent or metastatic solid tumors;
• Patients who have failed standard or conventional treatment, Including chemotherapy, targeted therapy, immunotherapy:

Documented disease progression after, or refractory to, or intolerant of prior standard or established therapy known to provide clinical benefit for their condition; or documented disease progression within 24 weeks after prior adjuvant/neoadjuvant therapy;

• At least one measurable lesion (by RECIST 1.1);
• Eastern Cooperative Oncology Group performance status score of 0 or 1;
• Life expectancy > 12 weeks;
• Patients should participate in the study voluntarily and sign informed consent.

Exclusion Criteria

• Untreated brain metastases or symptoms of brain metastases cannot be controlled more than 4 weeks;
• Other kinds of malignancies;
• Hematologic, renal, and hepatic function abnormities;
• Risk of bleeding;
• Gastrointestinal abnormalitiest;
• Cardiovascular and cerebrovascular diseases;
• Prior anti-tumor therapies with chemotherapy, radiotherapy, hormonotherapy, biotherapy, immunotherapy, operation within 4 weeks of enrollment;
• Presence of unresolved toxicities from prior anti-tumor therapy, defined as having not resolved to NCI CTCAE V5.0 grade 0 or 1 with the exception of alopecia;
• Involved in other clinical trials within 4 weeks of enrollment;
• Major surgical procedure, open biopsy, or significant traumatic injury 4 weeks days of enrollment;
• History of organ allograft;
• Need immunosuppressive agents or systemic or absorbable topical hormone therapy for immunosuppression;
• Uncontrolled ongoing or active infection;
• Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy;
• Pregnant or lactating women or those who do not take contraceptives, including men;
• Suffering from mental and neurological diseases;
• Any other metabolic dysfunction, abnormal physical examination findings, or clinical laboratory findings;
• Inability to comply with protocol required procedures.

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

Sponsors

Beijing Konruns Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

ChongQing University Cancer Hospital

Chongqing, Chongqing Municipality, China

Site Status: RECRUITING

The First Affiliated Hospital of Hainan Medical University

Haikou, Hainan, China

Site Status: RECRUITING

West China Hospital

Chengdu, Sichuan, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Junyu Wu, ph.D

Role: primary

wujy@konruns.cn

0086-10-82898888 ext. 6803

Weiqi Nian, ph.D

Role: backup

Junyu Wu, ph.D

Role: primary

wujy@konruns.cn

0086-10-82898888 ext. 6803

xinbao Hao, ph.D

Role: backup

Junyu Wu, Ph.D

Role: primary

wujy@konruns.cn

0086-10-82898888 ext. 6803

Yongsheng Wang, Ph.D

Role: backup

Qiu Li, Ph.D

Role: backup

Other Identifiers

KC1036-I-01

Identifier Type: -

Identifier Source: org_study_id