NCT05816252 is a Phase 2 clinical trial of SKB264 in Non-small Cell Lung Cancer, sponsored by Klus Pharma Inc..

Who is sponsoring NCT05816252?

NCT05816252 is sponsored by Klus Pharma Inc..

What drugs are being tested in NCT05816252?

Interventions in NCT05816252: SKB264, Pembrolizumab, Carboplatin, Osimertinib.

What condition does NCT05816252 study?

NCT05816252 studies Non-small Cell Lung Cancer.

Is NCT05816252 still recruiting?

NCT05816252 is currently active, enrolled. Last updated 27 January 2026.

Last reviewed 2026-01-27 · How we verify

NCT05816252

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

A Study of SKB264 (MK-2870; Sac-TMT) for the Treatment of Participants With Advanced or Metastatic Non-small Cell Lung Cancer (SKB264-II-04) (MK-2870-003)

Active, enrolled Phase 2 Last updated 27 January 2026

What this trial tests

Phase 2 trial testing SKB264 in Non-small Cell Lung Cancer in 356 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

19 April 2023

Primary endpoint
30 June 2026

30 December 2026

Quick facts

Lead sponsor	Klus Pharma Inc.
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	356
Start date	19 April 2023
Primary completion	30 June 2026
Estimated completion	30 December 2026
Sites	50 locations across Georgia, South Korea, Romania, China, Turkey (Türkiye), Spain

Drugs / interventions tested

SKB264 — full drug profile →
Pembrolizumab (pembrolizumab) — full drug profile →
Carboplatin (Carboplatin) — full drug profile →
Osimertinib (osimertinib) — full drug profile →

Conditions studied

Non-small Cell Lung Cancer — all drugs for Non-small Cell Lung Cancer →

Sponsor

Klus Pharma Inc.

Who can join

18 and older, any sex, with Non-small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to evaluate the safety, tolerability and objective response rate of SKB264 as combination with therapy in subjects with advanced or metastatic non-small cell lung cancer.

Publications & conference data

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

Drug conjugates for the treatment of lung cancer: from drug discovery to clinical practice.
Zhou L, Lu Y, Liu W, Wang S, et al · · 2024 · cited 27× · PMID 38429828 · DOI 10.1186/s40164-024-00493-8
The clinical development of antibody-drug conjugates for non-small cell lung cancer therapy.
Liu X, Deng J, Zhang R, Xing J, et al · · 2023 · cited 15× · PMID 38162667 · DOI 10.3389/fimmu.2023.1335252
Targeted therapy of non-small cell lung cancer: mechanisms and clinical trials.
Yu L, Yang R, Long Z, Tao Q, et al · · 2024 · cited 12× · PMID 39391239 · DOI 10.3389/fonc.2024.1451230

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
NCT05642780 — SKB264 in Combination With Pembrolizumab in Subjects With Selected Solid Tumors · Phase 2 · active not recruiting

Other recruiting trials for Non-small Cell Lung Cancer

Currently open trials in the same condition.

NCT07431827 — MK-3475A±Calderasib (MK-1084) in Completely Resected Stage IIA-IIIB (N2) KRAS G12Cm NSCLC (MK-1084-013) · Phase 3 · recruiting
NCT05987956 — Pharmacogenomics IND EXEMPT SNP Clinical Trial - Alectinib and Single Nucleotide Polymorphisms · Phase 2, PHASE3 · active not recruiting
NCT07195695 — Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer Wit · Phase 3 · recruiting
NCT06686771 — Radiotherapy to Block Oligoprogression In Metastatic Non-Small-Cell Lung Cancer · Phase 3 · recruiting
NCT06477055 — The Recurrence Gene Profiles of Adjuvant Osimertinib Therapy in Resected Non-Small-Cell Lung Cancer · recruiting

Other Klus Pharma Inc. trials

Trials by the same sponsor.

NCT05642780 — SKB264 in Combination With Pembrolizumab in Subjects With Selected Solid Tumors · 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 NCT05816252 (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: 27 January 2026

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/NCT05816252.

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