NCT05642780 is a Phase 2 clinical trial of SKB264 in Solid Tumor, sponsored by Klus Pharma Inc..

Who is sponsoring NCT05642780?

NCT05642780 is sponsored by Klus Pharma Inc..

What drugs are being tested in NCT05642780?

Interventions in NCT05642780: SKB264, Pembrolizumab.

What condition does NCT05642780 study?

NCT05642780 studies Solid Tumor.

Is NCT05642780 still recruiting?

NCT05642780 is currently active, enrolled. Last updated 14 October 2025.

Last reviewed 2025-10-14 · How we verify

NCT05642780

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

SKB264 in Combination With Pembrolizumab in Subjects With Selected Solid Tumors

Active, enrolled Phase 2 Last updated 14 October 2025

What this trial tests

Phase 2 trial testing SKB264 in Solid Tumor in 240 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

17 January 2023

Primary endpoint
30 November 2027

31 December 2027

Quick facts

Lead sponsor	Klus Pharma Inc.
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	240
Start date	17 January 2023
Primary completion	30 November 2027
Estimated completion	31 December 2027
Sites	48 locations across Belgium, Poland, Canada, Australia, China, United States

Drugs / interventions tested

SKB264 — full drug profile →
Pembrolizumab (pembrolizumab) — full drug profile →

Conditions studied

Solid Tumor — all drugs for Solid Tumor →

Sponsor

Klus Pharma Inc.

Who can join

18 and older, any sex, with Solid Tumor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

Antibody-drug conjugates as targeted therapy for treating gynecologic cancers: update 2025.
Silverstein J, Karlan B, Herrington N, Konecny G. · · 2025 · cited 9× · PMID 39480912 · DOI 10.1097/gco.0000000000001002
Value of Antibody Drug Conjugates for Gynecological Cancers: A Modern Appraisal Following Recent FDA Approvals.
McNamara B, Chang Y, Goreshnik A, Santin AD. · · 2023 · cited 8× · PMID 37663226 · DOI 10.2147/ijwh.s400537
Antibody-Drug Conjugates: A Start of a New Era in Gynecological Cancers.
Fasih S, Welch S, Lohmann AE. · · 2024 · cited 5× · PMID 39590153 · DOI 10.3390/curroncol31110522
Advances in Systemic Therapy for Ovarian Cancer Over the Past Decade: A Clinical and Molecular Perspective.
Abramiuk M, Skrabalak I, Satora M, Ostrowska-Leśko M, et al · · 2025 · cited 1× · PMID 40916573 · DOI 10.12659/msm.949526
Unlocking the potential of antibody-drug conjugates in cervical cancer: emerging targets and clinical trials.
Zhang Y, Ding Y, Liao Y, Shu J, et al · · 2025 · cited 1× · PMID 40697656 · DOI 10.3389/fphar.2025.1636120
TROP2-targeting antibody-drug conjugates in breast cancer and ovarian carcinoma: therapeutic advances and resistance mechanisms.
Eroles P, Dawid de Vera MT, Lago V. · · 2026 · PMID 42040770 · DOI 10.20517/cdr.2025.195
Treatment of Pelvic Recurrence After Radiotherapy for Cervical Cancer.
Song Y, Zou K, Zou L. · · 2025 · PMID 41463185 · DOI 10.3390/cancers17243934

Verify or expand the search:

Other trials of SKB264

Trials testing the same drug.

NCT07466927 — Study of Multi-mode Thermal Therapy Combined With Immunotherapy In Patients With HER2-negative Breast Cancer With Liver · Phase 2 · not yet recruiting
NCT06849492 — HIM Typing Guides the Treatment of Advanced First-Line Triple-Negative Breast Cancer · Phase 2 · not yet recruiting
NCT06081959 — Study of SKB264 for Locally Advanced, Recurrent or Metastatic HR+/HER2- Breast Cancer · Phase 3 · recruiting
NCT05870319 — A Phase III Study of SKB264 for EGFR Mutant NSCLC Patients · Phase 3 · active not recruiting
NCT05816252 — A Study of SKB264 (MK-2870; Sac-TMT) for the Treatment of Participants With Advanced or Metastatic Non-small Cell Lung C · Phase 2 · active not recruiting

Other recruiting trials for Solid Tumor

Currently open trials in the same condition.

NCT07489378 — NCI Childhood Cancer Data Initiative (CCDI) Led Pediatric, Adolescent, and Young Adult Rare Cancer Registry for Very Rar · recruiting
NCT07487597 — Functionally Enhanced ALPP-Targeted Engineered T Cells in Advanced Solid Tumors · EARLY_PHASE1 · recruiting
NCT07382544 — Phase 1b Trial of BMS-986504 in Combination With Olaparib in Patients With MTAP Loss · Phase 1 · recruiting
NCT07466160 — A Phase Ib/II Study of 7MW3711 Combined With JS207 in Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
NCT07450560 — Research on Real-time Proton Therapy Guidance Through Monitoring Proton Range Using All-digital PET · active not recruiting

Other Klus Pharma Inc. trials

Trials by the same sponsor.

NCT05816252 — A Study of SKB264 (MK-2870; Sac-TMT) for the Treatment of Participants With Advanced or Metastatic Non-small Cell Lung C · Phase 2 · active not recruiting
NCT04152499 — Phase I-II, FIH, TROP2 ADC, Advanced Unresectable/Metastatic Solid Tumors, Refractory to Standard Therapies (KL264-01) · Phase 1, PHASE2 · active not recruiting
NCT03602079 — Study of A166 in Patients With Relapsed/Refractory Cancers Expressing HER2 Antigen or Having Amplified HER2 Gene · Phase 1, PHASE2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05642780 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Klus Pharma Inc.
Last refreshed: 14 October 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05642780.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing