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Checkpoint Inhibitor

SKB264 + Pembrolizumab for Solid Tumors

Phase 2
Recruiting
Research Sponsored by Klus Pharma Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Cohort C: Subjects with recurrent ovarian cancer
Subjects with Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 .
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline until disease progression, death or other protocol defined reason up to approximately 21 months
Awards & highlights

Summary

"This trial aims to test whether a combination of SKB264 and Pembrolizumab is effective and safe for patients with certain types of solid tumors such as cervical, urothelial, ovarian

Who is the study for?
This trial is for people with certain advanced cancers (cervical, urothelial, ovarian, prostate) who are in good physical condition and expected to live at least 3 more months. They should have a measurable tumor and be able to provide tissue samples. Participants need decent organ and bone marrow function and must have recovered from previous therapy side effects.
What is being tested?
The study tests the effectiveness and safety of combining two drugs: SKB264 and Pembrolizumab, on patients with specific solid tumors. It aims to see how well these drugs work together in treating different types of cancer by measuring changes in tumor size.
What are the potential side effects?
Possible side effects include immune system reactions that can affect organs, fatigue, skin issues, flu-like symptoms, hormonal gland problems (like thyroid), infusion-related reactions, appetite changes, nausea or diarrhea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My ovarian cancer has come back.
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I am fully active or can carry out light work.
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My cervical cancer has returned or spread to other parts.
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I have advanced or metastatic bladder cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline until disease progression, death or other protocol defined reason up to approximately 21 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline until disease progression, death or other protocol defined reason up to approximately 21 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Dose limiting toxicity (DLT) and adverse events (AEs)
Objective Response Rate (ORR)
Prostate-specific antigen (PSA) response rate (Cohort D)

Trial Design

4Treatment groups
Experimental Treatment
Group I: cohort DExperimental Treatment2 Interventions
subjects will receive SKB264 in combination with pembrolizumab by intravenous administration
Group II: cohort CExperimental Treatment2 Interventions
subjects will receive SKB264 in combination with pembrolizumab by intravenous administration
Group III: cohort BExperimental Treatment2 Interventions
subjects will receive SKB264 in combination with pembrolizumab by intravenous administration
Group IV: cohort AExperimental Treatment2 Interventions
subjects will receive SKB264 in combination with pembrolizumab by intravenous administration
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2070

Find a Location

Who is running the clinical trial?

Myriad Genetics, Inc.Industry Sponsor
17 Previous Clinical Trials
5,389 Total Patients Enrolled
Discovery Life Sciences, LLCUNKNOWN
Ventana Medical Systems, IncUNKNOWN
~69 spots leftby Sep 2025
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