SKB264 in Combination With Pembrolizumab in Subjects With Selected Solid Tumors

NCT05642780 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: SKB264-II-06
• Study Type: interventional
• Target: 240
• Locations: 6 countries
• Sites: 48

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of combination of SKB264 and Pembrolizumab in patients with selected solid tumors including cervical cancer, urothelial cancer, ovarian cancer, prostate cancer,advanced endometrial cancer.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (3)

• Dose limiting toxicity (DLT) and adverse events (AEs)

  Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

  From subject sign the ICF to 30 days after the last dose of study treatment

• Objective Response Rate (ORR)

  ORR is defined as the proportion of subjects with confirmed CR or PR as the best overall response assessed per RECIST 1.1.

  From baseline until disease progression, death or other protocol defined reason up to approximately 21 months

• Prostate-specific antigen (PSA) response rate (Cohort D)

  The percentage of subjects in the analysis population who have a negative change (decrease) in PSA level of ≥ 50% measured twice ≥ 3 weeks apart

  From baseline until disease progression, death or other protocol defined reason up to approximately 21 months

Study Arms (5)

cohort A

EXPERIMENTAL

subjects will receive SKB264 in combination with pembrolizumab by intravenous administration

Drug: SKB264; Drug: Pembrolizumab

cohort B

EXPERIMENTAL

subjects will receive SKB264 in combination with pembrolizumab by intravenous administration

Drug: SKB264; Drug: Pembrolizumab

cohort C

EXPERIMENTAL

subjects will receive SKB264 in combination with pembrolizumab by intravenous administration

Drug: SKB264; Drug: Pembrolizumab

cohort D

EXPERIMENTAL

subjects will receive SKB264 in combination with pembrolizumab by intravenous administration

Drug: SKB264; Drug: Pembrolizumab

Cohort E

EXPERIMENTAL

subjects will receive SKB264 in combination with pembrolizumab by intravenous administration

Drug: SKB264; Drug: Pembrolizumab

Interventions

SKB264 DRUG

be administrated as an intravenous (IV) infusion on Day 1,15, 29 of each 42-day cycle;

Cohort E; cohort A; cohort B; cohort C; cohort D

Pembrolizumab DRUG

be administrated as an intravenous (IV) infusion on Day 1 of each 42-day cycle;

Also known as: Keytruda

Cohort E; cohort A; cohort B; cohort C; cohort D

Eligibility Criteria

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

You may qualify if:

• Subjects with Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 .
• Subjects with expected survival ≥ 3 months.
• Cohort A: Subjects with recurrent or metastatic cervical cancer
• Cohort B: Subjects with locally advanced or metastatic urothelial carcinoma
• Cohort C: Subjects with recurrent ovarian cancer
• Cohort D: Subjects with metastatic prostate cancer
• Subjects have at least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
• Subjects able to provide tumor blocks or slides for biomarker test.
• Subjects have relatively good organ function and bone marrow function.
• Subjects must have recovered from all toxicities from previous therapy with the exception of toxicities not considered a safety risk.
• Contraceptive use by men and women must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• Subject is capable of giving signed informed consent.
• Cohort E: Subjects with advanced endometrial cancer.

You may not qualify if:

• Subjects with active or untreated central nervous system (CNS) metastases and/or carcinomatous meningitis are not eligible.
• Subjects who suffer from cardiovascular diseases of clinical significance.
• Subjects with serious and/or uncontrolled concomitant diseases.
• Subjects diagnosed active hepatitis B or hepatitis C.
• Subjects have known human immunodeficiency virus (HIV) infection that is not well controlled.
• Subjects with known active tuberculosis.
• Known allergy or hypersensitivity to pembrolizumab or SKB264, or the excipients of pembrolizumab or SKB264.
• Subjects with history of allogeneic tissue/solid organ transplant.
• Subjects previously treated with TROP2 targeted therapy.
• Subjects who are vaccinated with live vaccine within 30 days before the first dose, or plan to be vaccinated with live vaccine during the study period.
• Subjects participating in another clinical study, unless it is an observational (non-intervention) clinical study or the follow-up period of an intervention study.
• The Investigator considers other situations that will interfere with the evaluation of the study intervention or the safety of the subjects or the interpretation of the results of the study.

Sponsors & Collaborators

• Klus Pharma Inc.: lead
• Myriad Genetics, Inc.: collaborator
• Discovery Life Sciences, LLC: collaborator
• Ventana Medical Systems, Inc: collaborator
• Frontage Laboratories, Inc.: collaborator
• Clario: collaborator

Study Sites (48)

Community Clinical Research Center

Anderson, Indiana, 46013, United States

Location

Norton Cancer Institute

Louisville, Kentucky, 40202, United States

Location

Anne Arundel Medical Center (AAMC)

Annapolis, Maryland, 21401, United States

Location

UT Health East Texas - Hope Cancer Center Tyler

Tyler, Minnesota, 75702, United States

Location

Westchester Medical Center

Hawthorne, New York, 10532, United States

Location

Texas Oncology, P.A. Amarillo, TX

Amarillo, Texas, 79103, United States

Location

Texas Oncology, P.A. Austin, TX

Austin, Texas, 72007, United States

Location

Oncology & Hematology Associates of Southwest Virginia, Inc. Roanoke, VA

Roanoke, Virginia, 36274, United States

Location

Icon Cancer Centre Wesley

Auchenflower, Queensland, 4066, Australia

Location

Flinders Medical Centre

Bedford Park, Australia

Location

Wollongong Hospital

Kogarah, Australia

Location

Algemeen Ziekenhuis Klina

Brasschaat, Belgium

Location

Grand Hôpital de Charleroi - Site Notre-Dame

Charleroi, Belgium

Location

Cliniques Universitaires Saint-Luc

Woluwe-Saint-Lambert, Belgium

Location

BC Cancer - Kelowna

Kelowna, British Columbia, V1Y5L3, Canada

Location

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Canada

Location

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

Location

Affiliated Cancer Hospital of Guangxi Medical University

Nanning, Guangxi, China

Location

Hubei Cancer Hospital

Wuhan, Hubei, China

Location

Hunan Cancer Hospital

Changsha, Hunan, China

Location

Jilin Cancer Hospital

Changchun, Jinlin, China

Location

The Second Hospital of Dalian

Dalian, Liaoning, China

Location

Weifang People's Hospital

Weifang, Shandong, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

Location

Beijing Obstetrics and Gynecology Hospital, Capital Medical University

Beijing, China

Location

Peking University First Hospital

Beijing, China

Location

The First Affiliated Hospital of Jilin University

Changchun, China

Location

Hunan Cancer Hospital

Changsha, China

Location

Chongqing Cancer Hospital

Chongqing, China

Location

Sun Yat-sen Memorial Hospital

Guangzhou, China

Location

Sun Yat-Sen University Cancer Center

Guangzhou, China

Location

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

Location

Zhejiang Provincial People's Hospital

Hangzhou, China

Location

Qilu Hosptial of Qlilu University

Jinan, China

Location

Shandong Cancer Hospital

Jinan, China

Location

Nanjing Drum Tower Hospital

Nanjing, China

Location

Fudan University Shanghai Cancer Center

Shanghai, China

Location

Obstetrics and Gynecology Hospital Affiliated to Fudan University

Shanghai, China

Location

Liaoning Cancer Hospital & Institute

Shenyang, China

Location

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, China

Location

Union Hospital, Tongji Medical College,Huazhong University of Science and Technology

Wuhan, China

Location

Zhongnan Hospital of Wuhan University

Wuhan, China

Location

Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou Universit

Zhengzhou, China

Location

Henan Cancer Hospital

Zhengzhou, China

Location

The first Affiliated Hospital of Zhengzhou University

Zhengzhou, China

Location

Szpitale Pomorskie Sp. z o.o.

Gdynia, Poland

Location

Pratia MCM Krakow

Krakow, 30-510, Poland

Location

Biokinetica S.A., Przychodnia Jozefow

Warsaw, Poland

Location

MeSH Terms

Interventions

pembrolizumab

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: December 8, 2022
• Study Start: January 17, 2023
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 14, 2025

Record last verified: 2025-10

Locations

US (8); BE (3); AU (3); CA (2); CN (29); PL (3)