Solid TumorPhase 2NCT05642780
SKB264 in Combination With Pembrolizumab in Subjects With Selected Solid Tumors
A Phase 2 study testing SKB264 and Pembrolizumab in people with Solid Tumor, run by Klus Pharma Inc. at 48 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- SKB264 and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 48 sitesin 6 countries
- Study dates
- 17 Jan 2023to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
48 sites in 6 countries.
48 sites in 6 countries
China29 sites
Beijing Obstetrics and Gynecology Hospital, Capital Medical University
Beijing
Peking University First Hospital
Beijing
Jilin Cancer Hospital
Changchun, Jinlin
The First Affiliated Hospital of Jilin University
Changchun
Hunan Cancer Hospital
Changsha, Hunan
Hunan Cancer Hospital
Changsha
Chongqing Cancer Hospital
Chongqing
The Second Hospital of Dalian
Dalian, Liaoning
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong
Sun Yat-sen Memorial Hospital
Guangzhou
Sun Yat-Sen University Cancer Center
Guangzhou
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou
Zhejiang Provincial People's Hospital
Hangzhou
Qilu Hosptial of Qlilu University
Jinan
Shandong Cancer Hospital
Jinan
Nanjing Drum Tower Hospital
Nanjing
Affiliated Cancer Hospital of Guangxi Medical University
Nanning, Guangxi
Fudan University Shanghai Cancer Center
Shanghai
Obstetrics and Gynecology Hospital Affiliated to Fudan University
Shanghai
Liaoning Cancer Hospital & Institute
Shenyang
Weifang People's Hospital
Weifang, Shandong
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou
Hubei Cancer Hospital
Wuhan, Hubei
Union Hospital, Tongji Medical College,Huazhong University of Science and Technology
Wuhan
Zhongnan Hospital of Wuhan University
Wuhan
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi
Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou Universit
Zhengzhou
Henan Cancer Hospital
Zhengzhou
The first Affiliated Hospital of Zhengzhou University
Zhengzhou
United States8 sites
Texas Oncology, P.A. Amarillo, TX
Amarillo, Texas, 79103
Community Clinical Research Center
Anderson, Indiana, 46013
Anne Arundel Medical Center (AAMC)
Annapolis, Maryland, 21401
Texas Oncology, P.A. Austin, TX
Austin, Texas, 72007
Westchester Medical Center
Hawthorne, New York, 10532
Norton Cancer Institute
Louisville, Kentucky, 40202
Oncology & Hematology Associates of Southwest Virginia, Inc. Roanoke, VA
Roanoke, Virginia, 36274
UT Health East Texas - Hope Cancer Center Tyler
Tyler, Minnesota, 75702
Australia3 sites
Icon Cancer Centre Wesley
Auchenflower, Queensland, 4066
Flinders Medical Centre
Bedford Park
Wollongong Hospital
Kogarah
Belgium3 sites
Algemeen Ziekenhuis Klina
Brasschaat
Grand Hôpital de Charleroi - Site Notre-Dame
Charleroi
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert
Poland3 sites
Szpitale Pomorskie Sp. z o.o.
Gdynia
Pratia MCM Krakow
Krakow, 30-510
Biokinetica S.A., Przychodnia Jozefow
Warsaw
Canada2 sites
BC Cancer - Kelowna
Kelowna, British Columbia, V1Y5L3
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal
About this study
Official 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
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
- Being tested
- SKB264, Pembrolizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SKB264Drug
be administrated as an intravenous (IV) infusion on Day 1,15, 29 of each 42-day cycle;
PembrolizumabDrug
Also called Keytruda
be administrated as an intravenous (IV) infusion on Day 1 of each 42-day cycle;
| Study group | Role | What they receive |
|---|---|---|
| cohort A | Experimental | subjects will receive SKB264 in combination with pembrolizumab by intravenous administration Receives: Drug: SKB264; Drug: Pembrolizumab |
| cohort B | Experimental | subjects will receive SKB264 in combination with pembrolizumab by intravenous administration Receives: Drug: SKB264; Drug: Pembrolizumab |
| cohort C | Experimental | subjects will receive SKB264 in combination with pembrolizumab by intravenous administration Receives: Drug: SKB264; Drug: Pembrolizumab |
| cohort D | Experimental | subjects will receive SKB264 in combination with pembrolizumab by intravenous administration Receives: Drug: SKB264; Drug: Pembrolizumab |
| Cohort E | Experimental | subjects will receive SKB264 in combination with pembrolizumab by intravenous administration Receives: Drug: SKB264; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: From baseline until disease progression, death or other protocol defined reason up to approximately 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start17 Jan 2023
- Primary completion30 Nov 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Klus Pharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Myriad Genetics, Inc., Discovery Life Sciences, LLC, Ventana Medical Systems, Inc, Frontage Laboratories, Inc., Clario
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05642780
- Sponsor's protocol ID
- SKB264-II-06
- Status last verified
- Oct 2025
- First submitted
- 30 Nov 2022
- Last updated
- 14 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05642780
- Acronym / sponsor ID
- SKB264-II-06
- Conditions
- Solid Tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Klus Pharma Inc.Industry (pharma, biotech, devices)
- Collaborators
- Myriad Genetics, Inc., Discovery Life Sciences, LLC, Ventana Medical Systems, Inc, Frontage Laboratories, Inc., Clario
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| cohort A | Experimental | Drug: SKB264, Drug: Pembrolizumabsubjects will receive SKB264 in combination with pembrolizumab by intravenous administration |
| cohort B | Experimental | Drug: SKB264, Drug: Pembrolizumabsubjects will receive SKB264 in combination with pembrolizumab by intravenous administration |
| cohort C | Experimental | Drug: SKB264, Drug: Pembrolizumabsubjects will receive SKB264 in combination with pembrolizumab by intravenous administration |
| cohort D | Experimental | Drug: SKB264, Drug: Pembrolizumabsubjects will receive SKB264 in combination with pembrolizumab by intravenous administration |
| Cohort E | Experimental | Drug: SKB264, Drug: Pembrolizumabsubjects will receive SKB264 in combination with pembrolizumab by intravenous administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SKB264be administrated as an intravenous (IV) infusion on Day 1,15, 29 of each 42-day cycle; | Drug | Cohort E, cohort A, cohort B, cohort C, cohort D |
| PembrolizumabAlso: Keytrudabe administrated as an intravenous (IV) infusion on Day 1 of each 42-day cycle; | Drug | Cohort E, cohort A, cohort B, cohort C, cohort D |
Primary outcome
Dose limiting toxicity (DLT) and adverse events (AEs)
Time frame: From subject sign the ICF to 30 days after the last dose of study treatment
Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Objective Response Rate (ORR)
Time frame: From baseline until disease progression, death or other protocol defined reason up to approximately 21 months
ORR is defined as the proportion of subjects with confirmed CR or PR as the best overall response assessed per RECIST 1.1.
Prostate-specific antigen (PSA) response rate (Cohort D)
Time frame: From baseline until disease progression, death or other protocol defined reason up to approximately 21 months
The percentage of subjects in the analysis population who have a negative change (decrease) in PSA level of ≥ 50% measured twice ≥ 3 weeks apart
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
48 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SKB264 and Pembrolizumab in people with Solid Tumor, run by Klus Pharma Inc. at 48 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in China, United States, Australia, Belgium, Poland and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity (DLT) and adverse events (AEs) (time frame: From subject sign the ICF to 30 days after the last dose of study treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2025.