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Not yet recruiting NCT07118709

A Study of KC1086 in Patients With Advanced Solid Tumors

Phase I Interventional Advanced Solid Tumors Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: KC1086.
Who it may be relevant to
Registry conditions: Advanced Solid Tumors Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase I Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Preliminary Efficacy of KC1086 in the Patients With Advanced Recurrent or Metastatic Solid Tumors

Overview

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

  • Drug KC1086
    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.

Primary outcome measures

  • Adverse events (AEs) [Time frame: approximately 3 years]
Secondary outcome measures (8)
  • Pharmacokinetics (PK) profile: Cmax [Time frame: approximately 3 years]
  • Pharmacokinetics (PK) profile: Tmax [Time frame: approximately 3 years]
  • Pharmacokinetics (PK) profile: T1/2 [Time frame: approximately 3 years]
  • Pharmacokinetics (PK) profile: AUC0-t and AUC0-∞ [Time frame: approximately 3 years]
  • Objective Response Rate (ORR) [Time frame: approximately 3 years]
  • Progression-free survival (PFS) [Time frame: approximately 3 years]
  • Disease Control Rate (DCR) [Time frame: approximately 3 years]
  • Duration of Response (DOR) [Time frame: approximately 3 years]

Eligibility criteria

Inclusion criteria

  • 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;
  • Life expectancy > 12 weeks;
  • Adequate bone marrow, renal, and hepatic function;
  • Patients should participate in the study voluntarily and sign informed consent.

Exclusion criteria

  • 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;
  • Involved in other clinical trials within 4 weeks before enrollment;
  • Prior anti-tumor therapies with radiotherapy, immunotherapy, operation within 4 weeks before enrollment;
  • 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;
  • Presence of unresolved toxicities from prior anti-tumor therapy, defined as having not resolved to NCI CTCAE 5.0 Grade 0 or 1;
  • Severe infection within 4 weeks prior to enrollment;
  • Uncontrolled massive ascites, pleural or pericardial effusion；
  • Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy;
  • Prior therapies with KAT6 inhibitors
  • Pregnant or lactating women;
  • 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.
  • Other patients are not eligible for enrollment assessed by investigators.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07118709 · KC1086-I-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗