Advanced Solid Tumors Cancer
Conditions
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.
Interventions
DRUGKC1086
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.
Sponsors
Beijing Konruns Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events (AEs) | approximately 3 years | Incidence of treatment-related AEs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Pharmacokinetics (PK) profile: Cmax | approximately 3 years | Peak Plasma Concentration |
| 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. |
| 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. |
Outcome results
None listed