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Combining SKB264 and Pembrolizumab for treating selected solid tumors

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

PHASE2 · Klus Pharma Inc. · NCT05642780

This study is testing if a new combination of two cancer treatments, SKB264 and Pembrolizumab, can help people with certain solid tumors feel better and improve their health.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment240 (estimated)
Ages18 Years and up
SexAll
SponsorKlus Pharma Inc. (industry)
Drugs / interventionspembrolizumab
Locations51 sites (Anderson, Indiana and 50 other locations)
Trial IDNCT05642780 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of SKB264 in combination with Pembrolizumab in patients with specific solid tumors, including cervical, urothelial, ovarian, prostate, and advanced endometrial cancers. Participants must have measurable lesions and a good performance status, and they will be monitored for treatment response and safety. The study aims to determine if this combination therapy can improve outcomes for these patients compared to existing treatments.

Who should consider this trial

Good fit: Ideal candidates include individuals with recurrent or metastatic cervical cancer, locally advanced or metastatic urothelial carcinoma, recurrent ovarian cancer, or metastatic prostate cancer.

Not a fit: Patients with solid tumors not specified in the study or those with poor organ function or performance status may not benefit from this study.

Why it matters

Potential benefit: If successful, this combination therapy could provide a new treatment option for patients with selected solid tumors, potentially improving survival rates and quality of life.

How similar studies have performed: Other studies have shown promising results with similar combination therapies, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.
13. Cohort E: Subjects with advanced endometrial cancer.

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.

Where this trial is running

Anderson, Indiana and 50 other locations

+1 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Solid Tumor

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.