Health TrialsbyHealthPanel

A Study of KC1036 in Patients with Advanced Solid Tumors

ConditionAdvanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Konruns Pharmaceutical Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically or cytologically confirmed recurrent or metastatic solid tumors;

At least one measurable lesion (by RECIST 1.1);

Eastern Cooperative Oncology Group performance status score of 0 or 1;

Life expectancy > 12 weeks;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

207 Participants
are divided into 1 treatment group
Group A: KC1036Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
First 4 weeks after initial administration of KC1036
2

Adverse events (AEs)

Incidence of treatment-related AEs

Time frame
From enrollment up to 30 days after last dose

Secondary outcomes

1

Pharmacokinetics (PK) profile: Cmax

Peak Plasma Concentration

Time frame
First 4 weeks after initial administration of KC1036
2

Pharmacokinetics (PK) profile: Tmax

Time to reach the maximum plasma concentration

Time frame
First 4 weeks after initial administration of KC1036
3

Pharmacokinetics (PK) profile: T1/2

Terminal half-life

Time frame
First 4 weeks after initial administration of KC1036
4

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

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

Time frame
First 4 weeks after initial administration of KC1036

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Konruns Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
Apply now