marked.bio

TROP2 ADC · ADC

sacituzumab tirumotecan

22 active trials across 5 of our biomarkers, targeting TROP2. Not approved for any biomarker on marked.bio yet.

Also known as sac-TMT, SKB264, MK-2870.

Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.

Biomarkers

BiomarkerActive trialsAll trialsFurthest active phase
EGFR exon 19 deletion / L858R 18 18 Phase 3
KRAS G12C 2 2 Phase 1/2
ALK fusion 1 1 Phase 2
KRAS G12D 1 1 Phase 1/2
MSI-H / dMMR 1 1 Phase 2

Sponsors

Industry sponsors leading active biomarker-selected trials of sacituzumab tirumotecan.

  1. Kelun-Biotech 5
  2. MSD (Merck & Co.) 4
  3. Convalife 1
  4. Klus Pharma 1

Trials

22 of 22 trials shown

  1. 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

    Active, not recruiting Phase 3 Kelun-Biotech Started 2024Primary completion 2027-05 NCT06670196

    sacituzumab tirumotecanosimertinib FDA EU

    …on With Osimertinib Versus Osimertinib in Patients With Epidermal Growth Factor Receptor (EGFR) Mutations, Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer

    EGFR exon 19 deletion / L858RNon-Small Cell Lung Cancer

  2. 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)

    Active, not recruiting Phase 3 MSD (Merck & Co.) Started 2024Primary completion 2028-08 NCT06305754

    sacituzumab tirumotecanpemetrexedcarboplatinH1 Receptor AntagonistH2 Receptor AntagonistAcetaminophen (or equivalent)dexamethasone

    …etrexed 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 EGF…

    EGFR exon 19 deletion / L858RNon-small Cell Lung Cancer (NSCLC)

  3. 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)

    Active, not recruiting Phase 3 MSD (Merck & Co.) Started 2023Primary completion 2027-05 NCT06074588

    sacituzumab tirumotecandocetaxelpemetrexed

    …iously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations or Other Genomic Alterations (MK-2870-004)

    EGFR exon 19 deletion / L858RNon-small Cell Lung Cancer (NSCLC)

  4. A Phase III Study of SKB264 for EGFR Mutant NSCLC Patients

    Active, not recruiting Phase 3 Kelun-Biotech Started 2023Primary completion 2024-07 NCT05870319

    sacituzumab tirumotecanpemetrexedcarboplatincisplatin

    A Phase III Study of SKB264 for EGFR Mutant NSCLC Patients

    EGFR exon 19 deletion / L858RNon-small Cell Lung Cancer

  5. A Phase II Study of Sacituzumab Tirumotecan in Combination With Furmonertinib in Patients With Non-squamous Non-Small Cell Lung Cancer Who Have Progressed After EGFR-TKI and Platinum-Based Chemotherapy

    Recruiting Phase 2 Tianjin Medical University Cancer Institute and Hospital Started 2026Primary completion 2028-01 NCT07548060

    sacituzumab tirumotecanfurmonertinib

    …er (AJCC)\], with tissue or blood-based genetic testing showing EGFR-sensitive mutations (19del and L858R).

    EGFR exon 19 deletion / L858RNSCLC Stage IV, EGFR Gene Mutation

  6. Sacituzumab Tirumotecan Plus Third-Generation TKI With/Without Radiotherapy for EGFR-Mutant NSCLC Brain Metastases

    Not yet recruiting Phase 2 Zhejiang Cancer Hospital Started 2026Primary completion 2027-06 NCT07343479

    sacituzumab tirumotecan

    … EGFR sensitizing mutation including exon 19 deletion (19-Del) or exon 21 point mutation (L858R);

    EGFR exon 19 deletion / L858RNSCLC (Advanced Non-small Cell Lung Cancer), EGFR Gene Mutations, Brain Metastasis

  7. Phase II Study of Sacituzumab Tirumotecan in Combination With Osimertinib for Neoadjuvant Treatment in Patients With Resectable Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer

    Recruiting Phase 2 Kelun-Biotech Started 2026Primary completion 2027-08 NCT07329322

    sacituzumab tirumotecanosimertinib FDA EU

    Confirmed by tumor histology, or cytology to have EGFR sensitizing mutations.

    EGFR exon 19 deletion / L858RNon-Small Cell Lung Cancer

  8. Sacituzumab Tirumotecan（Sac-TMT） and Brain Radotherapy for EGFR+ NSCLC With Brain Mets

    Not yet recruiting Phase 2 Xiaorong Dong Started 2026Primary completion 2027-07 NCT07789444

    sacituzumab tirumotecan

    Presence of EGFR-sensitizing mutations, including exon 19 deletion or exon 21 L858R point mutation.

    EGFR exon 19 deletion / L858RNon-Small Cell Lung Cancer, Brain Metastases From Non-small Cell Lung Cancer (NSCLC), EGFR Mutation Positive Advanced Non-Small Cell Lung Cancer

  9. Neoadjuvant Sacituzumab Tirumotecan and Limertinib for Potentially Resectable Stage Ⅲ EGFR-mutant Non-small Cell Lung Cancer

    Recruiting Phase 2 Shanghai Pulmonary Hospital, Shanghai Started 2026Primary completion 2026-06 NCT07323056

    sacituzumab tirumotecanlimertinib

    Patients with non-small cell lung cancer (NSCLC) with EGFR mutation confirmed by pathology

    EGFR exon 19 deletion / L858REGFR-mutant Non-small Cell Lung Cancer, Potentially Resectable

  10. A Phase II Study of SKB264 + SKB118 in Nsq-NSCLC After EGFR-TKI Failure

    Not yet recruiting Phase 2 Kelun-Biotech Started 2026Primary completion 2027-12 NCT07854509

    sacituzumab tirumotecan

    Confirmed EGFR-sensitizing mutations.

    EGFR exon 19 deletion / L858RNon-Squamous Non-Small Cell Lung Cancer

  11. A Clinical Study of MK-1084 With Other Treatments for Non-small Cell Lung Cancer (MK-3475-01F)

    Recruiting Phase 1/2 MSD (Merck & Co.) Started 2026Primary completion 2029-08 NCT07286149

    calderasibpatritumab deruxtecansacituzumab tirumotecancetuximabRescue Medications

    …of Kirsten rat sarcoma viral oncogene (KRAS) mutation of glycine to cysteine at codon 12 (G12C) mutations

    KRAS G12CKRAS G12DLung Neoplasm Malignant

  12. Lorlatinib Plus Sacituzumab Tirumotecan With Peripheral ctDNA Guidance as First-Line Therapy for ALK Fusion-Positive NSCLC

    Not yet recruiting Phase 2 Guangdong Association of Clinical Trials Started 2026Primary completion 2029-09 NCT07750704

    lorlatinib FDA EUsacituzumab tirumotecan

    Confirmation of ALK fusion by tumor histology, cytology, or blood-based testing;

    ALK fusionALK Positive Non-small Cell Lung Cancer

  13. SKB264 Plus KL-A167 in MSI-H/dMMR Advanced Gynecological Malignancies

    Not yet recruiting Phase 2 Peking Union Medical College Hospital Started 2026Primary completion 2028-09 NCT07738757

    sacituzumab tirumotecanKL-A167

    3\. dMMR or MSI-H subtype (defined as: deficiency/loss of mismatch repair (MMR) proteins MLH1, PMS2, MSH2, …

    MSI-H / dMMRRecurrent or Metastatic MSI-H/dMMR Gynecological Malignancies

  14. Sacituzumab Tirumotecan in Combination With Furmonertinib as Second-line Treatment for EGFR-mutant Advanced or Metastatic NSCLC After Failure of First-line Third-generation EGFR-TKI Therapy

    Not yet recruiting Phase 2 Fudan University Started 2025Primary completion 2026-07 NCT07193160

    sacituzumab tirumotecanfurmonertinib

    …ious EGFR mutation test results (known presence of EGFR mutations sensitive to EGFR-TKI \[Ex19del, L858R\], which may exist alone or concurrently with other EGFR mutations, possibly inclu…

    EGFR exon 19 deletion / L858RNSCLC (Non-small Cell Lung Cancer)

  15. Sacituzumab Tirumotecan (Sac-TMT) Plus Bevacizumab in 3rd Generation EGFR-TKI Treated Advanced EGFR-mutant Nonsquamous NSCLC With Brain Metastasis

    Not yet recruiting Phase 2 Li-kun Chen Started 2025Primary completion 2027-12 NCT07197008

    sacituzumab tirumotecanbevacizumab

    Histologically or cytologically confirmed nonsquamous NSCLC with EGFR-sensitive mutation (exon 19 deletion or exon 21 L858R mutation).

    EGFR exon 19 deletion / L858RLung Cancer

  16. A ctDNA-guided Phase II Trial of Osimertinib in Combination With Sacituzumab Tirumotecan in EGFR-mutated Advanced NSCLC Patients With Positive ctDNA After lead-in Osimertinib Monotherapy

    Recruiting Phase 2 Guangdong Association of Clinical Trials Started 2025Primary completion 2028-06 NCT07375316

    osimertinib FDA EUsacituzumab tirumotecan

    Presence of sensitizing EGFR mutation (exon 19 deletion and/or L858R);

    EGFR exon 19 deletion / L858RNon Small Cell Lung Cancer

  17. CVL006 Combination Therapy in Advanced Solid Tumors

    Not yet recruiting Phase 1/2 Convalife Started 2025Primary completion 2028-08 NCT07157956

    pemetrexedcarboplatinsacituzumab tirumotecantrastuzumab deruxtecanenfortumab vedotin

    …rm2.1, Arm2.2, Arm2.5 and Arm2.7: For NSCLC Arm2.1: Non-squamous, wild-type NSCLC Arm2.2: EGFRm nsqNSCLC Arm2.3: Malignant pleural mesothelioma Arm2.4: triple-negative breast cancer Arm…

    EGFR exon 19 deletion / L858RAdvanced Solid Tumor

  18. Trilaciclib in Patients Receiving Sacituzumab Tirumotecan for EGFR-mutated, Advanced Non-Small Cell Lung Cancer (NSCLC)

    Recruiting Phase 2 The First Affiliated Hospital of Xiamen University Started 2025Primary completion 2027-03 NCT06992739

    sacituzumab tirumotecan

    Patients with locally advanced or metastatic EGFR mutant non-small cell lung cancer diagnosed by histological or cytological examination, who have…

    EGFR exon 19 deletion / L858RNSCLC (Advanced Non-small Cell Lung Cancer), EGFR, Myelosuppression

  19. KEYMAKER-U01 Substudy 01J: A Study of Pembrolizumab Plus MK-1084 in Participants With Non-Small Cell Lung Cancer (NSCLC) With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) G12C Mutations (MK-3475-01J/KEYMAKER-U01J)

    Recruiting Phase 2 MSD (Merck & Co.) Started 2025Primary completion 2029-11 NCT07252739

    calderasibpembrolizumabcetuximabsacituzumab tirumotecanRescue medication

    …cid (ctDNA) that demonstrates the presence of Kirsten rat sarcoma viral oncogene homolog (KRAS) G12C mutations

    KRAS G12CMalignant Neoplasm

  20. 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, not recruiting Phase 2 Klus Pharma Started 2023Primary completion 2026-06 NCT05816252

    sacituzumab tirumotecanpembrolizumabcarboplatinosimertinib FDA EU

    or confirmed to harbor EGFR mutation;

    EGFR exon 19 deletion / L858RNon-small Cell Lung Cancer

  21. SKB264 Combinatiton Therapy in Patients With Advanced or Metastatic Non-small Cell Lung Cancer.

    Recruiting Phase 2 Kelun-Biotech Started 2022Primary completion 2026-08 NCT05351788

    sacituzumab tirumotecanKL-A167carboplatincisplatin

    Cohort 3: Patients with locally advanced/metastatic NSCLC with EGFR activating mutation and negative ALK fusion gene, who have failed previous treatment with EGFR-TKIs.

    EGFR exon 19 deletion / L858RNon-small Cell Lung Cancer

  22. Safety and Efficacy of Intrathecal Sacituzumab Tirumotecan for Leptomeningeal Metastasis in EGFR-TKI-Resistant Non-Small Cell Lung Cancer

    Not yet recruiting Phase 1 Henan Cancer Hospital Started 2026Primary completion 2027-12 NCT07702305

    sacituzumab tirumotecan

    Pathologically diagnosed as EGFR mutation-positive non-small cell lung cancer;

    EGFR exon 19 deletion / L858REGFR-TKI-resistant Non-small Cell Lung Cancer With Leptomeningeal Metastasis