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

Beijing Konruns Pharmaceutical Co., Ltd.3 sites in 1 country207 target enrollmentSeptember 4, 2020

ConditionsAdvanced Solid Tumors

InterventionsKC1036

Overview

Phase: Phase 1
Intervention: KC1036
Conditions: Advanced Solid Tumors
Sponsor: Beijing Konruns Pharmaceutical Co., Ltd.
Enrollment: 207
Locations: 3
Primary Endpoint: Maximum tolerated dose (MTD)
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 4, 2020

End Date

December 31, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Beijing Konruns Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

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;

Arms & Interventions

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.

Intervention: KC1036

Outcomes

Primary Outcomes

Maximum tolerated dose (MTD)

Time Frame: 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)

Time Frame: From enrollment up to 30 days after last dose

Incidence of treatment-related AEs

Secondary Outcomes

Pharmacokinetics (PK) profile: Tmax(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)
Duration of Response (DOR)(Every 6 weeks for the duration of study participation; estimated to be 12 months)
Pharmacokinetics (PK) profile: Cmax(First 4 weeks after initial administration of KC1036)
Disease Control Rate (DCR)(Every 6 weeks for the duration of study participation; estimated to be 12 months)
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])
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)
Progression-free survival (PFS)(Every 6 weeks for the duration of study participation; estimated to be 12 months)