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

NCT06726369 | Recruiting Phase 1

• 1 other identifier: MK-6204-001/SKB535-I-01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Advanced Solid Tumors

Keywords

ADC; safety; tolerability; pharmacokinetics

Outcome Measures

Primary Outcomes (3)

• 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.

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

• 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.

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

• Serious Adverse Event (SAE)

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

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

Secondary Outcomes (6)

• PK parameter AUC

  Through study completion, an average of 2 years

• PK parameter Cmax

  Through study completion, an average of 2 years

• PK parameter Cmin

  Through study completion, an average of 2 years

• Objective response rate (ORR)

  Through study completion, an average of 2 years

• Duration of response (DOR)

  Through study completion, an average of 2 years

Study Arms (1)

MK-6204 (SKB535) for Injection

EXPERIMENTAL

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

Drug: MK-6204 (SKB535) for Injection

Interventions

MK-6204 (SKB535) for Injection DRUG

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.

MK-6204 (SKB535) for Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years of age
• 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.
• 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.
• Have a performance status of 0 or 1 on the ECOG Performance Scale.
• The participant has provided documented informed consent for the study.
• Participants who agree to provide archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated.
• 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.

You may not qualify if:

• 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.
• 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.
• 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.
• 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.
• Received prior systemic anticancer therapy including investigational agents within 4 weeks or 5 half-lives, whichever is shorter, before intervention allocation.
• Known additional malignancy that is progressing or has required active treatment within the past 2 years.
• 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.

Sponsors & Collaborators

• Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.: lead

Study Sites (7)

Beijing Cancer Hospital

Beijing, 100142, China

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

MeSH Terms

Interventions

WW Domain-Containing Oxidoreductase

Intervention Hierarchy (Ancestors)

Short Chain Dehydrogenase-Reductases; NAD (+) and NADP (+) Dependent Alcohol Oxidoreductases; Alcohol Oxidoreductases; Oxidoreductases; Enzymes; Enzymes and Coenzymes; Tumor Suppressor Proteins; Neoplasm Proteins; Proteins; Amino Acids, Peptides, and Proteins

Central Study Contacts

Lin Shen

CONTACT

010-88196561; linshenpku@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 10, 2024
• Study Start: December 12, 2024
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 7, 2026

Record last verified: 2026-05

Locations

CN (7)