AzTrials
AzTrials

Advanced Solid Tumors CancerPhase 1NCT07118709

A Study of KC1086 in Patients With Advanced Solid Tumors

A Phase 1 study testing KC1086 in people with Advanced Solid Tumors Cancer, run by Beijing Konruns Pharmaceutical Co., Ltd..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors Cancer
What is being tested?
KC1086
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
No sites listed yet
Study dates
Aug 2025to Dec 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 15Show fewer
  • 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.

About this study

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

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.

Being tested
KC1086

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KC1086Drug

    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.

Study groups in NCT07118709
Study groupRoleWhat they receive
KC1086ExperimentalKC1086 are given orally once daily, 21 days as a cycle
Receives: Drug: KC1086

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse events (AEs)

    Incidence of treatment-related AEs

    Measured: approximately 3 years

Secondary outcomes (8)

  1. Pharmacokinetics (PK) profile: Cmax

    Peak Plasma Concentration

    Measured: approximately 3 years

  2. Pharmacokinetics (PK) profile: Tmax

    Time to reach the maximum plasma concentration

    Measured: approximately 3 years

  3. Pharmacokinetics (PK) profile: T1/2

    Terminal half-life

    Measured: 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

    Measured: approximately 3 years

  5. Objective Response Rate (ORR)

    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.

    Measured: approximately 3 years

  6. Progression-free survival (PFS)

    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.

    Measured: approximately 3 years

  7. Disease Control Rate (DCR)

    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.

    Measured: approximately 3 years

  8. Duration of Response (DOR)

    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.

    Measured: approximately 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2025
  2. Study startAug 2025 (estimated)
  3. Primary completionAug 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07118709
Sponsor's protocol ID
KC1086-I-01
Status last verified
Aug 2025
First submitted
1 Aug 2025
Last updated
12 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing KC1086 in people with Advanced Solid Tumors Cancer, run by Beijing Konruns Pharmaceutical Co., Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events (AEs) (time frame: approximately 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07118709.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in