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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05642780




Registration number
NCT05642780
Ethics application status
Date submitted
30/11/2022
Date registered
8/12/2022
Date last updated
16/08/2024

Titles & IDs
Public title
SKB264 in Combination With Pembrolizumab in Subjects With Selected Solid Tumors
Scientific title
A Multicenter, Open-label, Phase 2, Basket Study to Evaluate the Efficacy and Safety of SKB264 in Combination With Pembrolizumab in Subjects With Selected Solid Tumors
Secondary ID [1] 0 0
SKB264-II-06
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Tumor 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SKB264
Treatment: Drugs - Pembrolizumab

Experimental: cohort A - subjects will receive SKB264 in combination with pembrolizumab by intravenous administration

Experimental: cohort B - subjects will receive SKB264 in combination with pembrolizumab by intravenous administration

Experimental: cohort C - subjects will receive SKB264 in combination with pembrolizumab by intravenous administration

Experimental: cohort D - subjects will receive SKB264 in combination with pembrolizumab by intravenous administration


Treatment: Drugs: SKB264
be administrated as an intravenous (IV) infusion on Day 1,15, 29 of each 42-day cycle;

Treatment: Drugs: Pembrolizumab
be administrated as an intravenous (IV) infusion on Day 1 of each 42-day cycle;
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Dose limiting toxicity (DLT) and adverse events (AEs)
Timepoint [1] 0 0
From subject sign the ICF to 30 days after the last dose of study treatment
Primary outcome [2] 0 0
Objective Response Rate (ORR)
Timepoint [2] 0 0
From baseline until disease progression, death or other protocol defined reason up to approximately 21 months
Primary outcome [3] 0 0
Prostate-specific antigen (PSA) response rate (Cohort D)
Timepoint [3] 0 0
From baseline until disease progression, death or other protocol defined reason up to approximately 21 months

Eligibility
Key inclusion criteria
1. Subjects with Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 .
2. Subjects with expected survival = 3 months.
3. Cohort A: Subjects with recurrent or metastatic cervical cancer
4. Cohort B: Subjects with locally advanced or metastatic urothelial carcinoma
5. Cohort C: Subjects with recurrent ovarian cancer
6. Cohort D: Subjects with metastatic prostate cancer
7. Subjects have at least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
8. Subjects able to provide tumor blocks or slides for biomarker test.
9. Subjects have relatively good organ function and bone marrow function.
10. Subjects must have recovered from all toxicities from previous therapy with the exception of toxicities not considered a safety risk.
11. Contraceptive use by men and women must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
12. Subject is capable of giving signed informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subjects with active or untreated central nervous system (CNS) metastases and/or carcinomatous meningitis are not eligible.
2. Subjects who suffer from cardiovascular diseases of clinical significance.
3. Subjects with serious and/or uncontrolled concomitant diseases.
4. Subjects diagnosed active hepatitis B or hepatitis C.
5. Subjects have known human immunodeficiency virus (HIV) infection that is not well controlled.
6. Subjects with known active tuberculosis.
7. Known allergy or hypersensitivity to pembrolizumab or SKB264, or the excipients of pembrolizumab or SKB264.
8. Subjects with history of allogeneic tissue/solid organ transplant.
9. Subjects previously treated with TROP2 targeted therapy.
10. 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.
11. Subjects participating in another clinical study, unless it is an observational (non-intervention) clinical study or the follow-up period of an intervention study.
12. 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/01/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
22/11/2025
Actual
Sample size
Target
184
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Icon Cancer Centre Wesley - Auchenflower
Recruitment hospital [2] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [3] 0 0
Wollongong Hospital - Kogarah
Recruitment postcode(s) [1] 0 0
4066 - Auchenflower
Recruitment postcode(s) [2] 0 0
- Bedford Park
Recruitment postcode(s) [3] 0 0
- Kogarah
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Indiana
Country [2] 0 0
United States of America
State/province [2] 0 0
Kentucky
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
Minnesota
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
United States of America
State/province [7] 0 0
Virginia
Country [8] 0 0
Belgium
State/province [8] 0 0
Brasschaat
Country [9] 0 0
Belgium
State/province [9] 0 0
Charleroi
Country [10] 0 0
Belgium
State/province [10] 0 0
Woluwe-Saint-Lambert
Country [11] 0 0
Canada
State/province [11] 0 0
British Columbia
Country [12] 0 0
Canada
State/province [12] 0 0
Montreal
Country [13] 0 0
China
State/province [13] 0 0
Guangdong
Country [14] 0 0
China
State/province [14] 0 0
Guangxi
Country [15] 0 0
China
State/province [15] 0 0
Hubei
Country [16] 0 0
China
State/province [16] 0 0
Hunan
Country [17] 0 0
China
State/province [17] 0 0
Jinlin
Country [18] 0 0
China
State/province [18] 0 0
Liaoning
Country [19] 0 0
China
State/province [19] 0 0
Shandong
Country [20] 0 0
China
State/province [20] 0 0
Shanxi
Country [21] 0 0
China
State/province [21] 0 0
Beijing
Country [22] 0 0
China
State/province [22] 0 0
Changchun
Country [23] 0 0
China
State/province [23] 0 0
Changsha
Country [24] 0 0
China
State/province [24] 0 0
Chongqing
Country [25] 0 0
China
State/province [25] 0 0
Guangzhou
Country [26] 0 0
China
State/province [26] 0 0
Hangzhou
Country [27] 0 0
China
State/province [27] 0 0
Jinan
Country [28] 0 0
China
State/province [28] 0 0
Nanjing
Country [29] 0 0
China
State/province [29] 0 0
Shanghai
Country [30] 0 0
China
State/province [30] 0 0
Shenyang
Country [31] 0 0
China
State/province [31] 0 0
Wenzhou
Country [32] 0 0
China
State/province [32] 0 0
Wuhan
Country [33] 0 0
China
State/province [33] 0 0
Zhengzhou
Country [34] 0 0
Poland
State/province [34] 0 0
Gdynia
Country [35] 0 0
Poland
State/province [35] 0 0
Krakow
Country [36] 0 0
Poland
State/province [36] 0 0
Warszawa

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Klus Pharma Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Myriad Genetics, Inc.
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Discovery Life Sciences, LLC
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Ventana Medical Systems, Inc
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Frontage Laboratories, Inc.
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT05642780
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jin Xiaoping
Address 0 0
Country 0 0
Phone 0 0
86-028-67255165
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05642780