SKB264 in Combination With Pembrolizumab in Subjects With Selected Solid Tumors

Sponsor

Klus Pharma Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05642780

Collaborator

(none)

184

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Solid Tumor	Drug: SKB264 Drug: Pembrolizumab	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

184 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Dec 23, 2022

Anticipated Primary Completion Date :

Sep 30, 2025

Anticipated Study Completion Date :

Nov 22, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: cohort A subjects will receive SKB264 in combination with pembrolizumab by intravenous administration	Drug: SKB264 be administrated as an intravenous (IV) infusion on Day 1,15, 29 of each 42-day cycle; Drug: Pembrolizumab be administrated as an intravenous (IV) infusion on Day 1 of each 42-day cycle; Other Names: Keytruda
Experimental: cohort B subjects will receive SKB264 in combination with pembrolizumab by intravenous administration	Drug: SKB264 be administrated as an intravenous (IV) infusion on Day 1,15, 29 of each 42-day cycle; Drug: Pembrolizumab be administrated as an intravenous (IV) infusion on Day 1 of each 42-day cycle; Other Names: Keytruda
Experimental: cohort C subjects will receive SKB264 in combination with pembrolizumab by intravenous administration	Drug: SKB264 be administrated as an intravenous (IV) infusion on Day 1,15, 29 of each 42-day cycle; Drug: Pembrolizumab be administrated as an intravenous (IV) infusion on Day 1 of each 42-day cycle; Other Names: Keytruda
Experimental: cohort D subjects will receive SKB264 in combination with pembrolizumab by intravenous administration	Drug: SKB264 be administrated as an intravenous (IV) infusion on Day 1,15, 29 of each 42-day cycle; Drug: Pembrolizumab be administrated as an intravenous (IV) infusion on Day 1 of each 42-day cycle; Other Names: Keytruda

Outcome Measures

Primary Outcome Measures

Dose limiting toxicity (DLT) and adverse events (AEs) [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) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Klus Pharma Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Klus Pharma Inc.

ClinicalTrials.gov Identifier:

NCT05642780

Other Study ID Numbers:

SKB264-II-06

First Posted:

Dec 8, 2022

Last Update Posted:

Dec 12, 2022

Last Verified:

Nov 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neoplasms

Pembrolizumab

Study Results

No Results Posted as of Dec 12, 2022