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NCT Number: NCT05642780

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Solid Tumor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Icon Cancer Centre Wesley, Auchenflower, Queensland, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

SKB264

Drug

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

Pembrolizumab

Drug

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

Other names: Keytruda

Primary outcomes

  1. 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.

  2. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

Klus Pharma Inc.

Industry

Collaborators

  • Clario
  • Discovery Life Sciences, LLC
  • Frontage Laboratories, Inc.
  • Myriad Genetics, Inc.
  • Ventana Medical Systems, Inc

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Dec 8, 2022
Registry last updated
Oct 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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