Sacituzumab tirumotecan

Phase 3Antibody–drug conjugate

Sacituzumab tirumotecan is one of 496 therapeutic programs targeting Penile Squamous Cell Carcinoma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

495

Competitors

Pipeline

Status by Indication[2][1]

Indication

Penile Squamous Cell CarcinomaNot yet recruiting

SacituzumabRecruiting

Breast NeoplasmsRecruiting

Non-Small Cell Lung Cancer (NSCLC)Active, not recruiting

Cervical CancerActive, not recruiting

Bladder CancerNot yet recruiting

Non-Small Cell Lung CancerRecruiting

Ovarian CancerRecruiting

Lung Neoplasm MalignantRecruiting

Esophageal Squamous Cell CarcinomaRecruiting

Penile Squamous Cell CarcinomaPhase 2

Not yet recruiting

SacituzumabPhase 2

Recruiting

Breast NeoplasmsPhase 3

Recruiting

Non-Small Cell Lung Cancer (NSCLC)Phase 3

Active, not recruiting

Cervical CancerPhase 3

Active, not recruiting

Bladder CancerPhase 3

Not yet recruiting

Non-Small Cell Lung CancerPhase 3

Recruiting

Ovarian CancerPhase 3

Recruiting

Lung Neoplasm MalignantPhase 2

Recruiting

Esophageal Squamous Cell CarcinomaPhase 2

Recruiting

Showing 10 of 33 indications

Competition

Competitive Landscape

449 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Sacituzumab tirumotecan

Merck & Co.

Phase 3

5 2

AK112

SSummit Therapeutics

Phase 3

4 3

Gotistobart

OOncoC4, Inc.

Phase 3

1 4

Remeron

OOrganon and Co

Preclinical

1 5

Aqupla

Jiangsu Simcere Pharmaceutical Co., Ltd.

Preclinical

—6

Ftorafur

TThe First Affiliated Hospital with Nanjing Medical University

Preclinical

—7

Vibramycin

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Treatment

1 9

Valemetostat Tosylate

Daiichi Sankyo

Preclinical

1 10

PD-1 Inhibitors

BBioNTech US Inc.

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2027

Phase 1Not yet recruiting

EGFR-TKI-Resistant Non-Small Cell Lung Cancer

NCT07702305

Q1 2028

Phase 3Active, not recruiting

Endometrial Cancer

NCT06132958

Phase 1Active, not recruiting

Non-Small Cell Lung Cancer

NCT06049212

Phase 2Active, not recruiting

NSCLC (advanced Non-Small Cell Lung Cancer)

NCT07703228

Q2 2028

Phase 3Active, not recruiting

Cervical Cancer

NCT06459180

Q3 2028

Phase 2Not yet recruiting

Advanced Biliary Tract Cancer(btc)

NCT07701122

Clinical

Trials by Indication[1]

Non-Small Cell Lung Cancer5 trials

A Phase 3 Randomized Open-Label Study of Adjuvant Pembrolizumab With or Without MK-2870 in Participants With Resectable Stage II to IIIB (N2) NSCLC Not Achieving pCR After Receiving Neoadjuvant Pembrolizumab With Platinum-based Doublet Chemotherapy Followed by Surgery

Recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT06312137·780 enrolled

A Phase II Study of Toripalimab Combined With Sacituzumab Tirumotecan as Neoadjuvant Therapy for Resectable Non-Small Cell Lung Cancer

Not yet recruiting·SShaodong Hong·Phase 2·NCT07819578·30 enrolled

Phase 1 Trial of MK-2870 as Monotherapy and in Combination With Pembrolizumab ± Chemotherapy in Subjects With Advanced Solid Tumors

Active, not recruiting· Merck & Co. logo

Merck & Co.·Phase 1·NCT06049212·30 enrolled

Show 2 more trials

A Phase II, Multicenter Study of Sacituzumab Tirumotecan (SKB264) Combined With Brain Radiotherapy in EGFR Mutation-Positive Advanced Non-Small Cell Lung Cancer With Brain Metastasis After Progression on First-Line Third-Generation EGFR-Tyrosine Kinase Inhibitors

Not yet recruiting·XXiaorong Dong·Phase 2·NCT07789444·53 enrolled

A Multicenter, Phase II Clinical Study to Evaluate the Safety and Efficacy 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·SSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.·Phase 2·NCT07329322·30 enrolled

Esophageal Squamous Cell Carcinoma4 trials

A Phase 1/2 Open-Label, Umbrella Platform Design Study of Investigational Agents in Combination With Pembrolizumab (MK-3475) With or Without Chemotherapy in Participants With 1L Locally Advanced Unresectable/Metastatic Esophageal Cancer: KEYMAKER-U06 Substudy 06E

Recruiting· Merck & Co. logo

Merck & Co.·Preclinical·NCT06780111·298 enrolled

A Prospective, Single-arm, Phase II Study of Neoadjuvant Sacituzumab Tirumotecan (SKB264/MK-2870) Combined With Toripalimab in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma

Not yet recruiting·HHebei Medical University Fourth Hospital·Phase 2·NCT07823270·33 enrolled

The Efficacy and Safety of Sacituzumab Govitecan Plus Tislelizumab in Locally Advanced/Metastatic Esophageal Squamous Cell Carcinoma (ESCC) Patients Who Progressed on Prior Immune Checkpoint Inhibitors (ICIs)

Recruiting·SShanghai Chest Hospital·Phase 2·NCT07811752·28 enrolled

Show 1 more trial

A Phase 1/2 Open-Label, Umbrella Platform Design Study of Investigational Agents With or Without Pembrolizumab (MK-3475) and/or Chemotherapy in Participants With Advanced Esophageal Cancer Previously Exposed to PD-1/PD-L1 Treatment (KEYMAKER-U06): Substudy 06B

Recruiting· Merck & Co. logo

Merck & Co.·Preclinical·NCT05319730·230 enrolled

Non-small Cell Lung Cancer (NSCLC)3 trials

A Randomized, Open-label, Phase 3 Study of MK-2870 in Combination With Pembrolizumab Compared to Pembrolizumab Monotherapy in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer With PD-L1 TPS Greater Than or Equal to 50% (TroFuse-007)

Recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT06170788·614 enrolled

A Randomized, Open-label, Phase 3 Study of MK-2870 vs. Platinum Doublets in Participants With EGFR-mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors

Active, not recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT06305754·550 enrolled

A Randomized, Open-label, Phase 3 Study of MK-2870 vs Chemotherapy (Docetaxel or Pemetrexed) in Previously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations or Other Genomic Alterations

Active, not recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT06074588·556 enrolled

Cervical Cancer2 trials

A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab With or Without Bevacizumab Compared With Standard of Care as Firstline Maintenance Treatment for Participants With Persistent, Recurrent, or Newly Diagnosed Metastatic Cervical Cancer With PD-L1 CPS Greater Than or Equal to 1 (TroFuse-036/GOG-3123/ENGOT-cx22)

Recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT07216703·1,023 enrolled

A Phase 3 Randomized, Active-controlled, Open-label, Multicenter Study to Compare the Efficacy and Safety of MK-2870 Monotherapy Versus Treatment of Physician's Choice as Second-line Treatment for Participants With Recurrent or Metastatic Cervical Cancer (TroFuse-020/GOG-3101/ENGOT-cx20)

Active, not recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT06459180·686 enrolled

Bladder Cancer2 trials

A Phase 3, Randomized, Open-label Study of Sacituzumab Tirumotecan (MK-2870) Versus Investigator's Choice of Non-platinum Chemotherapy in Participants With Pretreated Locally Advanced/Metastatic Urothelial Carcinoma

Recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT07419295·590 enrolled

A Randomized, Open-label, Phase II Study Evaluating the Neurotoxicity and Efficacy of Sacituzumab Tirumotecan (Sac-TMT) Versus MMAE-based ADCs in Patients With Advanced Urothelial Carcinoma: The SPARE-UC-01 Trial

Not yet recruiting·FFudan University·Phase 2·NCT07662863·75 enrolled

32 more indications

Endometrial Cancer2 trials

A Phase 3 Randomized, Open-label, Multicenter Study to Compare the Efficacy and Safety of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in Combination With Pembrolizumab Versus Pembrolizumab Alone as First-line Maintenance Treatment in Participants With Mismatch Repair Proficient Endometrial Cancer (TroFuse-033/GOG-3119/ENGOT-en29)

Recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT06952504·1,123 enrolled

A Phase 3, Randomized, Active-controlled, Open-label, Multicenter Study to Compare the Efficacy and Safety of MK-2870 Monotherapy Versus Treatment of Physician's Choice in Participants With Endometrial Cancer Who Have Received Prior Platinum-based Chemotherapy and Immunotherapy (MK-2870-005/ENGOT-en23/GOG-3095)

Active, not recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT06132958·710 enrolled

Breast Neoplasms2 trials

A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Sac-TMT (Sacituzumab Tirumotecan, MK-2870) Followed by Carboplatin/Paclitaxel vs Chemotherapy, Both in Combination With Pembrolizumab as Neoadjuvant Therapy for High-Risk, Early-Stage, Triple-Negative Breast Cancer or Hormone Receptor-low Positive/Human Epidermal Growth Factor Receptor-2 Negative Breast Cancer

Recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT06966700·2,400 enrolled

An Open-label, Randomized Phase 3 Study of MK-2870 as a Single Agent and in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer

Recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT06312176·1,200 enrolled

Gastroesophageal Adenocarcinoma2 trials

A Phase 1/2 Open-Label, Umbrella Platform Design Study to Evaluate the Safety and Efficacy of Investigational Agents in Combination With Standard of Care Treatments as the Second-Line Treatment of Participants With Advanced/Metastatic Gastroesophageal Adenocarcinoma: Substudy 06D

Recruiting· Merck & Co. logo

Merck & Co.·Preclinical·NCT06445972·210 enrolled

A Phase 1/2 Open-Label, Umbrella Platform Design Study of Investigational Agents With Pembrolizumab (MK-3475) and Chemotherapy in Participants With 1L Locally Advanced Unresectable/Metastatic Gastroesophageal Adenocarcinoma (Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, and Esophageal Adenocarcinoma): Substudy 06C

Recruiting· Merck & Co. logo

Merck & Co.·Preclinical·NCT06469944·160 enrolled

Lung Neoplasm Malignant2 trials

KEYMAKER-U01 Substudy 01F: A Phase 1b/2 Umbrella Study With Rolling Arms of Investigational Agents for Previously Treated Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With KRAS G12C Mutations

Recruiting· Merck & Co. logo

Merck & Co.·Preclinical·NCT07286149·140 enrolled

KEYMAKER-U01 Substudy 01E: A Phase 2 Umbrella Study With Rolling Arms of Investigational Agents With or Without Chemotherapy in Combination With Pembrolizumab in Treatment of Participants With Newly Diagnosed Resectable Stages II-IIIB (N2) Non-small Cell Lung Cancer (NSCLC)

Recruiting· Merck & Co. logo

Merck & Co.·Phase 2·NCT06788912·60 enrolled

Thymic Carcinoma2 trials

A Phase II Clinical Study of Sacituzumab Tirumotecan in Participants With Locally Advanced or Metastatic Thymic Carcinoma With Treatment Failure After Platinum-Based Therapy

Recruiting·SSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.·Phase 2·NCT07324629·30 enrolled

A Phase II, Investigator-Initiated Exploratory Study of Sacituzumab Tirumotecan for Previously Treated Unresectable Thymic Carcinomas

Not yet recruiting·NNational Cancer Center, Japan·Phase 2·NCT07750353·35 enrolled

Sacituzumab1 trial

Phase II Trial of Sacituzumab Tirumotecan in Patients With SMARCB1-Deficient Renal Medullary Carcinoma

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT07438626·20 enrolled

Triple-Negative Breast Cancer1 trial

A Phase 3, Randomized, Open-label, Study to Compare the Efficacy and Safety of Adjuvant MK-2870 in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice (TPC) in Participants With Triple-Negative Breast Cancer (TNBC) Who Received Neoadjuvant Therapy and Did Not Achieve a Pathological Complete Response (pCR) at Surgery

Recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT06393374·1,530 enrolled

Ovarian Neoplasms1 trial

A Phase 3, Randomized, Open-label, Multicenter Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) Maintenance Treatment With or Without Bevacizumab Versus Standard of Care in Participants With Newly Diagnosed Advanced Non-HRD Positive Ovarian Cancer Following First-line Platinum-based Chemotherapy (TroFuse-021/ENGOTov85/GOG-3102)

Recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT07318558·900 enrolled

Colorectal Cancer1 trial

A Phase 1/2 Study to Evaluate the Safety and Efficacy of MK-2870 Monotherapy or in Combination With Other Anticancer Agents in Gastrointestinal Cancers

Recruiting· Merck & Co. logo

Merck & Co.·Preclinical·NCT06428409·220 enrolled

Ovarian Clear Cell Carcinoma1 trial

A Phase 2 Non-comparative Screening Trial of Sacituzumab Tirumotecan (MK2870) Alone and in Combination With Pembrolizumab in Ovarian Clear Cell Carcinoma Previously Exposed to Immunotherapy

Recruiting·TTufts Medical Center·Phase 2·NCT07718854·50 enrolled

Triple Negative Breast Neoplasms1 trial

A Phase 3, Randomized, Open-label Study Comparing Efficacy and Safety of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as a Monotherapy and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With Previously Untreated Locally Recurrent Unresectable or Metastatic Triple-Negative Breast Cancer Expressing PD-L1 at CPS Less Than 10 (TroFuse-011)

Recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT06841354·1,000 enrolled

Penile Squamous Cell Carcinoma1 trial

A Single-arm Phase II Trial of Sacituzumab Tirumotecan (Sac-TMT; MK-2870) as Second-line Treatment for Advanced/Metastatic Penile Squamous Cell Carcinoma: PERSEUS TRIAL (LACOG 1924)

Not yet recruiting·LLatin American Cooperative Oncology Group·Phase 2·NCT07815197·37 enrolled