A Study of KC1086 in Patients With Advanced Solid Tumors

Not Applicable

Not yet recruiting

• Conditions: Advanced Solid Tumors Cancer
• Interventions: Drug: KC1086

• Registration Number: NCT07118709
• Lead Sponsor: Beijing Konruns Pharmaceutical Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study Start: 2025-08-01
• Study First Submitted: 2025-08-01
• Study First Submitted QC: 2025-08-07
• Last Update Submitted: 2025-08-07
• Study First Posted: 2025-08-12
• Last Update Posted: 2025-08-12
• Primary Completion: 2028-08
• Study Completion: 2028-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

1. Histologically or cytologically confirmed recurrent or metastatic solid tumors;
2. 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);
3. Participants with advanced recurrent, unresectable, and/or metastatic tumors must have evaluable or measurable lesions (according to RECIST 1.1)；
4. Eastern Cooperative Oncology Group performance status score of 0 or 1;
5. Life expectancy > 12 weeks;
6. Adequate bone marrow, renal, and hepatic function;
7. Patients should participate in the study voluntarily and sign informed consent.

Exclusion Criteria

1. Any patient who is known to have untreated central nervous system (CNS) metastasis;
2. Other kinds of malignancies within 5 years;
3. Gastrointestinal abnormalities;
4. Cardiovascular and cerebrovascular diseases;
5. Involved in other clinical trials within 4 weeks before enrollment;
6. Prior anti-tumor therapies with radiotherapy, immunotherapy, operation within 4 weeks before enrollment;
7. Prior anti-tumor therapies with small molecule targeting drugs within 2weeks or 5 half-lives (whichever is longer) before enrollment; Prior anti-tumor therapies with chemotherapy within 3 weeks or 5 half-lives (whichever is longer) before enrollment;
8. Presence of unresolved toxicities from prior anti-tumor therapy, defined as having not resolved to NCI CTCAE 5.0 Grade 0 or 1;
9. Severe infection within 4 weeks prior to enrollment;
10. Uncontrolled massive ascites, pleural or pericardial effusion；
11. Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy;
12. Prior therapies with KAT6 inhibitors
13. Pregnant or lactating women;
14. Female subjects of child-bearing potential and male subjects of reproductive capacity who do not agree to use contraceptive measures during the study and for 6 months after the end of the study.
15. Other patients are not eligible for enrollment assessed by investigators.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
KC1086	KC1086	KC1086 are given orally once daily, 21 days as a cycle

Primary Outcome Measures

Name	Time	Method
Adverse events (AEs)	approximately 3 years	Incidence of treatment-related AEs

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK) profile: Cmax	approximately 3 years	Peak Plasma Concentration
Pharmacokinetics (PK) profile: Tmax	approximately 3 years	Time to reach the maximum plasma concentration
Pharmacokinetics (PK) profile: T1/2	approximately 3 years	Terminal half-life
Pharmacokinetics (PK) profile: AUC0-t and AUC0-∞	approximately 3 years	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)	approximately 3 years	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)	approximately 3 years	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)	approximately 3 years	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)	approximately 3 years	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.