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RecruitingNCT06726369Updated May 7, 2026

A Phase 1 Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of MK-6204 (SKB535) for Injection in Participants With Advanced Solid Tumors

A Phase 1 interventional study of MK-6204 (SKB535) for Injection in Advanced Solid Tumors, sponsored by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.. Recruiting at 7 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-07.

Sponsored by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2024; still recruiting 1 year 9 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
90
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This is an open-label, nonrandomized, multicenter, Phase 1 study to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of MK-6204 as monotherapy in participants with advanced solid tumors.

Read the detailed description

This is an open-label, nonrandomized, multicenter, Phase 1 study to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of MK-6204 as monotherapy in participants with advanced solid tumors. The primary objectives are to evaluate the safety and tolerability of MK-6204. The secondary endpoints include PK parameters, ORR, DOR, and immunogenicity of MK-6204. The study will include a Screening Phase, a Treatment Phase, and a Post-treatment Follow up Phase.

02

Conditions studied

  • Advanced Solid Tumors

Keywords

  • ADC
  • safety
  • tolerability
  • pharmacokinetics
03

In context

Lead sponsor

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. is the lead sponsor of 55 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. ≥ 18 years of age
  2. Have a histologically or cytologically confirmed advanced/metastatic solid tumor by pathology report and have failed or do not have available standard treatments. The tumor types will be limited to: CRC; Gastric carcinoma or gastroesophageal junction (GEJ) adenocarcinoma; Esophageal carcinoma; Pancreatic cancer; NSCLC; Cervical carcinoma; Head and Neck squamous cell carcinoma.
  3. Have measurable disease by RECIST 1.1 as assessed by the local site investigator/radiology. Target lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions.
  4. Have a performance status of 0 or 1 on the ECOG Performance Scale.
  5. The participant has provided documented informed consent for the study.
  6. Participants who agree to provide archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated.
  7. Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible.

Exclusion criteria

Exclusion Criteria:

  1. Active severe digestive disease, including but not limited to complete or incomplete gastric outlet obstruction, persistent/recurrent vomiting, severe gastrointestinal hemorrhage, gastric or duodenal ulcers, acute gastrointestinal perforation, acute necrotizing pancreatitis, ulcerative enteritis, congenital megacolon, or Crohn's disease.
  2. Participants with a history of interstitial lung disease (ILD) or a history of noninfectious pneumonitis that required steroids, have current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
  3. Received strong cytochrome P450 (CYP3A4) inhibitors or inducers within 2 weeks prior to the first dose of study intervention or within 5 half-lives of drug elimination, whichever is longer.
  4. Received strong breast cancer resistance protein (BCRP) inhibitors within 2 weeks prior to the first dose of study intervention or within 5 half-lives of drug elimination, whichever is longer.
  5. Received prior systemic anticancer therapy including investigational agents within 4 weeks or 5 half-lives, whichever is shorter, before intervention allocation.
  6. Known additional malignancy that is progressing or has required active treatment within the past 2 years.
  7. Known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable (i.e., without evidence of progression) for at least 4 weeks as confirmed by repeat imaging performed during the study screening, are clinically stable and have not required steroid treatment for at least 14 days before the first dose of study intervention.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    MK-6204 (SKB535) for Injection

    Several dose levels of MK-6204 (SKB535) for Injection are planned and administered every 3 weeks.

    Drug: MK-6204 (SKB535) for Injection

Interventions

  • DrugMK-6204 (SKB535) for Injection

    MK-6204 (SKB535) for injection is administered every 3 weeks (q3w) until radiographic disease progression (PD), intolerable toxicity, death, or discontinuation of treatment, whichever occurs first.

06

What researchers measure

Primary outcomes

  1. Dose Limiting Toxicities (DLT)

    DLT is defined as an adverse event (AE) that meets protocol defined DLT criteria during the evaluation period and is at least possibly related to study drug.

    Time frame: From the date of first dose until up to 21 days of intervention

  2. Adverse Event (AE)

    An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether considered related to the study intervention.

    Time frame: From the date of first dose until up to 30 days after the last dose of intervention

  3. Serious Adverse Event (SAE)

    An SAE is defined as any serious untoward medical occurrence that meets the pre-specified criteria in the protocol

    Time frame: From the date of first dose until up to 30 days after the last dose of intervention

Secondary outcomes

  1. PK parameter AUC

    PK parameter AUC after single and multiple doses

    Time frame: Through study completion, an average of 2 years

  2. PK parameter Cmax

    PK parameter Cmax after single and multiple doses

    Time frame: Through study completion, an average of 2 years

  3. PK parameter Cmin

    PK parameter Cmin after single and multiple doses

    Time frame: Through study completion, an average of 2 years

  4. Objective response rate (ORR)

    ORR refers to the proportion of participants who have achieved confirmed complete response (CR) or partial response (PR).

    Time frame: Through study completion, an average of 2 years

  5. Duration of response (DOR)

    DOR refers to the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.

    Time frame: Through study completion, an average of 2 years

  6. Immunogenicity of MK-6204

    ADA incidence

    Time frame: Through study completion, an average of 2 years

07

Study locations

1 of 7 sites recruiting
  • Beijing Cancer Hospital
    Beijing, 100142, China
    • Lin Shen, Dr. · Contact
    • Lin Shen, Dr. · Principal investigator
    Recruiting
  • Hunan Cancer Hospital
    Changsha, 410031, China
    Not yet recruiting
  • West China Hospital of Sichuan University
    Chengdu, China
    Not yet recruiting
  • Chongqing University Cancer Hospital
    Chongqing, China
    Not yet recruiting
  • Fujian Provincial Cancer Hospital
    Fuzhou, China
    Not yet recruiting
  • Shanghai East Hospital
    Shanghai, China
    Not yet recruiting
  • Hubei Cancer Hospital
    Wuhan, China
    Not yet recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06726369
Lead sponsor
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Dec 10, 2024
Start date
Dec 12, 2024
Primary completion
Dec 31, 2029 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
May 7, 2026

Study contacts

Lin Shen
Contact
linshenpku@163.com
010-88196561

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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