Sacituzumab Tirumotecan

Summary

Sacituzumab Tirumotecan (CHEMBL5314875) is a phase-3 clinical-stage antibody drug conjugate targeting TACSTD2; indicated across 8 conditions including non-small cell lung carcinoma and breast neoplasm.

At a glance

• Status: Max clinical phase 3 (not approved)
• Modality: Antibody drug conjugate
• Targets: 1 (TACSTD2)
• Indications: 8 conditions
• Clinical trials: 68

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL5314875
Name	Sacituzumab Tirumotecan
Type	Antibody drug conjugate
Max phase	3

Also known as: Mk-2870, MK2870, Sacituzumab tirumotecan, SKB-264, Skb264, SACITUZUMAB TIRUMOTECAN

Targets

Targets

Primary targets (GtoPdb curated mechanism): the Cancer dependency column is the DepMap CRISPR fitness signal (% of screened cell lines dependent on the target).

Gene	Target	Action	pAffinity	Cancer dependency	UniProt
TACSTD2	tumor associated calcium signal transducer 2	Binding	9.51	0.7%	P09758

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

Aggregated over 1 target gene(s): TACSTD2.

Dominant GO biological processes

GO term	Targets
visual perception	1
negative regulation of epithelial cell migration	1
regulation of epithelial cell proliferation	1
negative regulation of stress fiber assembly	1
ureteric bud morphogenesis	1
negative regulation of branching involved in ureteric bud morphogenesis	1
negative regulation of substrate adhesion-dependent cell spreading	1
negative regulation of ruffle assembly	1
negative regulation of cell motility	1
positive regulation of stem cell differentiation	1

Indications & clinical

Indications

8 indications (0 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
non-small cell lung carcinoma	3	MONDO:0005233	EFO:0003060
breast neoplasm	3	MONDO:0021100	EFO:0003869
endometrium neoplasm	3	MONDO:0021251	MONDO:0011962
neoplasm	2	MONDO:0005070	EFO:0000616
esophageal squamous cell carcinoma	1	MONDO:0005580	EFO:0005922
urothelial carcinoma	1	MONDO:0040679	EFO:0008528

2 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 68.

Phase distribution

Phase	Trials
PHASE2	33
PHASE3	24
PHASE1/PHASE2	9
PHASE1	1
Not specified	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT05347134	PHASE3	ACTIVE_NOT_RECRUITING	SKB264 Injection vs Investigator Selected Regimens to Treat Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer
NCT05870319	PHASE3	ACTIVE_NOT_RECRUITING	A Phase III Study of SKB264 for EGFR Mutant NSCLC Patients
NCT06074588	PHASE3	ACTIVE_NOT_RECRUITING	Sacituzumab Tirumotecan (MK-2870) Versus Chemotherapy in Previously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations or Other Genomic Alterations (MK-2870-004)
NCT06081959	PHASE3	RECRUITING	Study of SKB264 for Locally Advanced, Recurrent or Metastatic HR+/HER2- Breast Cancer
NCT06132958	PHASE3	ACTIVE_NOT_RECRUITING	Sacituzumab Tirumotecan (MK-2870) in Post Platinum and Post Immunotherapy Endometrial Cancer (MK-2870-005)
NCT06170788	PHASE3	RECRUITING	Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥ 50% (MK-2870-007)
NCT06279364	PHASE3	RECRUITING	A Study of SKB264 Versus Investigator’s Choice Chemotherapy in Patients With Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer
NCT06305754	PHASE3	ACTIVE_NOT_RECRUITING	Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)
NCT06312137	PHASE3	RECRUITING	A Study to Assess Efficacy and Safety of Pembrolizumab With or Without Sacituzumab Tirumotecan (MK- 2870) in Adult Participants With Resectable Non Small Cell Lung Cancer (NSCLC) Not Achieving Pathological Complete Response (pCR) (MK-2870-019)
NCT06312176	PHASE3	RECRUITING	A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician’s Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010)
NCT06356311	PHASE3	ACTIVE_NOT_RECRUITING	A Study to Evaluate Sacituzumab Tirumotecan (MK-2870) in Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-2870-015)
NCT06393374	PHASE3	RECRUITING	Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR (MK-2870-012)
NCT06448312	PHASE3	ACTIVE_NOT_RECRUITING	A Study of SKB264 in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
NCT06459180	PHASE3	ACTIVE_NOT_RECRUITING	A Study to Compare Sacituzumab Tirumotecan (MK-2870) Monotherapy Versus Treatment of Physician’s Choice as Second-line Treatment for Participants With Recurrent or Metastatic Cervical Cancer (MK-2870-020/TroFuse-020/Gog-3101/ENGOT-cx20)
NCT06670196	PHASE3	RECRUITING	A Study of SKB264 in Combination With Osimertinib Versus Osimertinib in Patients With Epidermal Growth Factor Receptor (EGFR) Mutations, Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer
NCT06711900	PHASE3	RECRUITING	A Study of SKB264 in Combination With Pembrolizumab Versus Chemotherapy in Combination With Pembrolizumab as First-Line Treatment for PD-L1 Negative Patients With Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer
NCT06824467	PHASE3	RECRUITING	A Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Maintenance Treatment Versus Standard of Care in Participants With Platinum-sensitive Recurrent Ovarian Cancer (MK-2870-022/TroFuse-022/ENGOT-ov84/GOG-3103)
NCT06841354	PHASE3	RECRUITING	A Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Triple-Negative Breast Cancer (MK-2870-011/TroFuse-011)
NCT06952504	PHASE3	RECRUITING	A Study to Compare Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) Versus Pembrolizumab Alone as Treatment in Participants With Mismatch Repair Proficient Endometrial Cancer (MK-2870-033/TroFuse-033/GOG-3119/ENGOT-en29)
NCT06966700	PHASE3	RECRUITING	A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)
NCT07071337	PHASE3	RECRUITING	A Study of SKB264 Versus Investigator’s Choice of Chemotherapy in Subjects With Unresectable Locally Advanced, Relapsed, or Metastatic HR+/HER2- Breast Cancer Who Have Previously Failed Endocrine Therapy
NCT07216703	PHASE3	RECRUITING	A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
NCT07318558	PHASE3	RECRUITING	A Clinical Trial of Sac-TMT in People With Non-HRD Positive Advanced Ovarian Cancer (MK-2870-021)
NCT07419295	PHASE3	RECRUITING	A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) to Treat Urothelial Cancer (MK-2870-031)
NCT04152499	PHASE1/PHASE2	ACTIVE_NOT_RECRUITING	Phase I-II, FIH, TROP2 ADC, Advanced Unresectable/Metastatic Solid Tumors, Refractory to Standard Therapies (KL264-01)
NCT05319730	PHASE1/PHASE2	RECRUITING	A Study to Evaluate Investigational Agents With or Without Pembrolizumab (MK-3475) in Participants With Advanced Esophageal Cancer Previously Exposed to Programmed Cell Death 1 Protein (PD-1)/ Programmed Cell Death Ligand 1 (PD-L1) Treatment (MK-3475-06B)
NCT05351788	PHASE2	RECRUITING	SKB264 Combinatiton Therapy in Patients With Advanced or Metastatic Non-small Cell Lung Cancer.
NCT05445908	PHASE2	ACTIVE_NOT_RECRUITING	SKB264 +/- KL-A167 in Recurrent or Metastatic HER2-negative Breast Cancer
NCT05631262	PHASE2	ACTIVE_NOT_RECRUITING	SKB264 Monotherapy in Selected Subjects With Advanced Solid Tumors
NCT05642780	PHASE2	ACTIVE_NOT_RECRUITING	SKB264 in Combination With Pembrolizumab in Subjects With Selected Solid Tumors
NCT05816252	PHASE2	ACTIVE_NOT_RECRUITING	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)
NCT06428409	PHASE1/PHASE2	RECRUITING	A Clinical Study of MK-2870 Alone or With Other Treatments to Treat Gastrointestinal Cancers (MK-9999-02A)
NCT06445972	PHASE1/PHASE2	RECRUITING	Substudy 06D: Combination Therapies in Second Line (2L) Gastroesophageal Adenocarcinoma (MK-3475-06D/Keymaker-U06)
NCT06483334	PHASE1/PHASE2	ACTIVE_NOT_RECRUITING	A Study of Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Plus Enfortumab Vedotin (EV) With and Without Pembrolizumab in Advanced Urothelial Carcinoma (MK-3475-04C/KEYMAKER-U04)
NCT06637423	PHASE1/PHASE2	RECRUITING	A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Patients With Bladder Cancer (MK-2870-027)
NCT06780111	PHASE1/PHASE2	RECRUITING	Substudy 06E: Umbrella Study of Combination Therapies in Esophageal Cancer (MK-3475-06E/KEYMAKER-U06)
NCT06788912	PHASE2	RECRUITING	Pembrolizumab (MK-3475) Plus Investigational Agents in Resectable Non-small Cell Lung Cancer (NSCLC) (MK-3475-01E/KEYMAKER-U01)
NCT06849492	PHASE2	NOT_YET_RECRUITING	HIM Typing Guides the Treatment of Advanced First-Line Triple-Negative Breast Cancer
NCT06992739	PHASE2	RECRUITING	Trilaciclib in Patients Receiving Sacituzumab Tirumotecan for EGFR-mutated, Advanced Non-Small Cell Lung Cancer (NSCLC)
NCT07007780	PHASE2	NOT_YET_RECRUITING	Sacituzumab Tirumotecan in Neoadjuvant Treatment of Early-Stage TNBC

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).