A Study of KC1036 in Patients With Advanced Solid Tumors

Sponsor

Beijing Konruns Pharmaceutical Co., Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04387916

Collaborator

(none)

207

Enrollment

Locations

Arm

34.8

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Solid Tumors	Drug: KC1036	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

207 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase I, Open-label, Dose Escalation Study Evaluating the Safety, Pharmacokinetics and Preliminary Efficacy of KC1036 in the Patients With Advanced Recurrent or Metastatic Solid Tumors

Actual Study Start Date :

Sep 4, 2020

Anticipated Primary Completion Date :

Jul 31, 2022

Anticipated Study Completion Date :

Jul 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: KC1036 Part 1: Dose-escalation phase , KC1036 10mg~120mg, 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.

Arm

Intervention/Treatment

Experimental: 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.

Drug: KC1036

Part 1: Dose-escalation phase , KC1036 10mg~120mg, 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.

Outcome Measures

Primary Outcome Measures

Maximum tolerated dose (MTD) [First 4 weeks after initial administration of KC1036]
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.
Adverse events (AEs) [From enrollment up to 30 days after last dose]
Incidence of treatment-related AEs

Secondary Outcome Measures

Pharmacokinetics (PK) profile: Cmax [First 4 weeks after initial administration of KC1036]
Peak Plasma Concentration
Pharmacokinetics (PK) profile: Tmax [First 4 weeks after initial administration of KC1036]
Time to reach the maximum plasma concentration
Pharmacokinetics (PK) profile: T1/2 [First 4 weeks after initial administration of KC1036]
Terminal half-life
Pharmacokinetics (PK) profile: AUC0-t and AUC0-∞ [First 4 weeks after initial administration of KC1036]
Area under the single-dose plasma concentration-time curve from Hour 0 to the last quantifiable measurable plasma concentration, or Area under the single-dose plasma concentration-time curve from Hour 0 to infinity
Objective Response Rate (ORR) [Every 6 weeks for the duration of study participation; estimated to be 12 months]
Overall response rate (ORR) was defined as the percentage of participants with a best overall complete response (CR) or partial response (PR) per RECIST 1.1.
Progression-free survival (PFS) [Every 6 weeks for the duration of study participation; estimated to be 12 months]
Progression-free survival (PFS) was defined as the time from the start date of study drug to the date of the first radiologically documented progressive disease (PD) per RECIST 1.1 or death due to any cause.
Disease Control Rate (DCR) [Every 6 weeks for the duration of study participation; estimated to be 12 months]
Disease Control Rate (DCR) was defined as the percentage of participants with a best overall complete response (CR), partial response (PR), or stable disease (SD) per RECIST 1.1.
Duration of Response (DOR) [Every 6 weeks for the duration of study participation; estimated to be 12 months]
Duration of response (DOR) was defined as the time from first documented response (partial response (PR) or complete response (CR)) to the date of first documented disease progression (PD) or death due to any cause, among patients with a confirmed PR or CR per RECIST 1.1.
Overall Survival (OS) [From the first medication to death due to any cause; estimated to be the subject's death, loss to follow-up, or end of the study]]
Overall Survival (OS) was defined as the time from the start date of study drug to the date of death due to any cause.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country
1	ChongQing University Cancer Hospital	ChongQing	Chongqing	China
2	The First Affiliated Hospital of Hainan Medical University	Haikou	Hainan	China
3	West China Hospital	Chengdu	Sichuan	China

Sponsors and Collaborators

Beijing Konruns Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Beijing Konruns Pharmaceutical Co., Ltd.

ClinicalTrials.gov Identifier:

NCT04387916

Other Study ID Numbers:

KC1036-I-01

First Posted:

May 14, 2020

Last Update Posted:

Aug 17, 2021

Last Verified:

Aug 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neoplasms

Study Results

No Results Posted as of Aug 17, 2021