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

Phase 1

Recruiting

• Conditions: Advanced Solid Tumors
• Interventions: Drug: MK-6204 (SKB535) for Injection

• Registration Number: NCT06726369
• Lead Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

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.

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.

Study Timeline

• Study First Submitted: 2024-12-02
• Study First Submitted QC: 2024-12-05
• Study First Posted: 2024-12-10
• Study Start: 2024-12-12
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-13
• Primary Completion: 2029-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Dose Limiting Toxicities (DLT)	From the date of first dose until up to 21 days of intervention	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.
Adverse Event (AE)	From the date of first dose until up to 30 days after the last dose of intervention	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.
Serious Adverse Event (SAE)	From the date of first dose until up to 30 days after the last dose of intervention	An SAE is defined as any serious untoward medical occurrence that meets the pre-specified criteria in the protocol

Secondary Outcome Measures

Name	Time	Method
PK parameter Cmin	Through study completion, an average of 2 years	PK parameter Cmin after single and multiple doses
PK parameter AUC	Through study completion, an average of 2 years	PK parameter AUC after single and multiple doses
PK parameter Cmax	Through study completion, an average of 2 years	PK parameter Cmax after single and multiple doses
Objective response rate (ORR)	Through study completion, an average of 2 years	ORR refers to the proportion of participants who have achieved confirmed complete response (CR) or partial response (PR).
Duration of response (DOR)	Through study completion, an average of 2 years	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.
Immunogenicity of MK-6204	Through study completion, an average of 2 years	ADA incidence

Trial Locations

Locations (7)

Beijing Cancer Hospital; 🇨🇳 Beijing, China

Hunan Cancer Hospital; 🇨🇳 Changsha, China

West China Hospital of Sichuan University; 🇨🇳 Chengdu, China

Chongqing University Cancer Hospital; 🇨🇳 Chongqing, China

Shanghai East Hospital; 🇨🇳 Shanghai, China

Fujian Provincial Cancer Hospital; 🇨🇳 Fuzhou, China

Hubei Cancer Hospital; 🇨🇳 Wuhan, China