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A Study of KC1086 in Patients With Advanced Solid Tumors

ConditionAdvanced Solid Tumors Cancer
Trial statusNot yet recruiting
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 KC1086 in participants with advanced recurrent or metastatic solid tumors. The trial will be divided into two parts: dose-escalation phase and dose-expansion phase.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically or cytologically confirmed recurrent or metastatic solid tumors;

Patients who have failed standard or conventional treatment or for whom no standard treatment is available( definition of treatment failure: intolerable toxic and side effects, disease progression during treatment recurrence after treatment);

Participants with advanced recurrent, unresectable, and/or metastatic tumors must have evaluable or measurable lesions (according to RECIST 1.1)；

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

Disqualifiers

Any patient who is known to have untreated central nervous system (CNS) metastasis;

Other kinds of malignancies within 5 years;

Gastrointestinal abnormalities;

Cardiovascular and cerebrovascular diseases;

Trial design

Design model

Single group

Treatments tested in this trial

  • KC1086

    Drug

    Part 1: Dose-escalation phase , five dose groups are included: 1 mg, 2 mg, 4 mg, 6 mg, and 8 mg. Part 2: Dose-expansion phase, 2 to 3 dose levels will be selected for expansion based on the results of the dose escalation phase.

Treatment groups

66 Participants
are divided into 1 treatment group
Group A: KC1086Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Adverse events (AEs)

Incidence of treatment-related AEs

Time frame
approximately 3 years

Secondary outcomes

1

Pharmacokinetics (PK) profile: Cmax

Peak Plasma Concentration

Time frame
approximately 3 years
2

Pharmacokinetics (PK) profile: Tmax

Time to reach the maximum plasma concentration

Time frame
approximately 3 years
3

Pharmacokinetics (PK) profile: T1/2

Terminal half-life

Time frame
approximately 3 years
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
approximately 3 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Beijing Konruns Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: