A Study of KC1036 in Patients with Advanced Solid Tumors

NCT04387916 | Recruiting Phase 1

• 1 other identifier: KC1036-I-01
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose (MTD)

  MTD will be defined as the maximum dose level at which no more than 1 of 3 participants experience a dose-limiting toxicity (DLT) within the first 4 weeks of multiple dosing.

  First 4 weeks after initial administration of KC1036

• Adverse events (AEs)

  Incidence of treatment-related AEs

  From enrollment up to 30 days after last dose

Secondary Outcomes (9)

• Pharmacokinetics (PK) profile: Cmax

  First 4 weeks after initial administration of KC1036

• Pharmacokinetics (PK) profile: Tmax

  First 4 weeks after initial administration of KC1036

• Pharmacokinetics (PK) profile: T1/2

  First 4 weeks after initial administration of KC1036

• Pharmacokinetics (PK) profile: AUC0-t and AUC0-∞

  First 4 weeks after initial administration of KC1036

• Objective Response Rate (ORR)

  Every 6 weeks for the duration of study participation; estimated to be 12 months

Study Arms (1)

KC1036

EXPERIMENTAL

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.

Drug: KC1036

Interventions

KC1036 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.

KC1036

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Beijing Konruns Pharmaceutical Co., Ltd.: lead

Study Sites (3)

ChongQing University Cancer Hospital

Chongqing, Chongqing Municipality, China

RECRUITING

The First Affiliated Hospital of Hainan Medical University

Haikou, Hainan, China

RECRUITING

West China Hospital

Chengdu, Sichuan, China

RECRUITING

Study Design

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

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: May 14, 2020
• Study Start: September 4, 2020
• Primary Completion: October 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 17, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)