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- |||||||||| sacituzumab tirumotecan (MK-2870) / Merck (MSD), Keytruda (pembrolizumab) / Merck (MSD)
New P3 trial, Combination therapy, Metastases: U1111-1301-2790: Pembrolizumab With or Without Maintenance Sacituzumab Tirumotecan (Sac-TMT; MK-2870) in Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) [MK-2870-023] (clinicaltrials.gov) - May 20, 2024
P3, N=851, Not yet recruiting, Sponsor: Merck Sharp & Dohme LLC
- |||||| sacituzumab tirumotecan (MK-2870) / Merck (MSD)
Enrollment open, Metastases: A Study to Evaluate Sacituzumab Tirumotecan (MK-2870) in Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-2870-015) (clinicaltrials.gov) - May 13, 2024
P3, N=450, Recruiting, Sponsor: Merck Sharp & Dohme LLC
Not yet recruiting --> Recruiting
- sacituzumab tirumotecan (MK-2870) / Merck (MSD)
Sacituzumab tirumotecan (SKB264/MK-2870) in patients (pts) with previously treated locally recurrent or metastatic triple-negative breast cancer (TNBC): Results from the phase III OptiTROP-Breast01 study. (Hall D1) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2909;
P3
trial, SKB264 was compared with physician's choice of chemotherapy (eribulin, vinorelbine, capecitabine, or gemcitabine) in pts with locally recurrent or metastatic TNBC who had received two or more prior therapies including at least one for metastatic setting... Sacituzumab tirumotecan monotherapy demonstrated statistically significant and clinically meaningful PFS and OS benefit over chemotherapy, with a manageable safety profile in pts with heavily pretreated advanced TNBC and limited treatment options.
- sacituzumab tirumotecan (MK-2870) / Merck (MSD), tagitanlimab (HBM9167) / Harbour BioMed
Sacituzumab tirumotecan (SKB264/MK-2870) in combination with KL-A167 (anti-PD-L1) as first-line treatment for patients with advanced NSCLC from the phase II OptiTROP-Lung01 study. (Arie Crown Theater) - Apr 24, 2024 - Abstract #ASCO2024ASCO_1381;
P2, P3
A Phase 3 study of SKB264 Q2W plus pembrolizumab vs pembrolizumab in 1L metastatic NSCLC with PD-L1 TPS ? 50% (NCT06170788) is ongoing.
- |||||| sacituzumab tirumotecan (MK-2870) / Merck (MSD), Keytruda (pembrolizumab) / Merck (MSD)
Enrollment open, Surgery: 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) (clinicaltrials.gov) - Apr 17, 2024
P3, N=780, Recruiting, Sponsor: Merck Sharp & Dohme LLC
50% (NCT06170788) is ongoing. Not yet recruiting --> Recruiting
- |||||||||| sacituzumab tirumotecan (MK-2870) / Merck (MSD)
New P3 trial, Metastases: A Study to Evaluate Sacituzumab Tirumotecan (MK-2870) in Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-2870-015) (clinicaltrials.gov) - Apr 10, 2024
P3, N=450, Not yet recruiting, Sponsor: Merck Sharp & Dohme LLC
- |||||| sacituzumab tirumotecan (MK-2870) / Merck (MSD), Keytruda (pembrolizumab) / Merck (MSD)
Enrollment open, Combination therapy, Metastases: 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) (clinicaltrials.gov) - Apr 4, 2024
P3, N=1200, Recruiting, Sponsor: Merck Sharp & Dohme LLC
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- |||||||||| sacituzumab tirumotecan (MK-2870) / Merck (MSD), Keytruda (pembrolizumab) / Merck (MSD)
New P3 trial, Surgery: 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) (clinicaltrials.gov) - Mar 15, 2024
P3, N=780, Not yet recruiting, Sponsor: Merck Sharp & Dohme LLC
- |||||||||| sacituzumab tirumotecan (MK-2870) / Merck (MSD), Keytruda (pembrolizumab) / Merck (MSD)
New P3 trial, Combination therapy, Metastases: 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) (clinicaltrials.gov) - Mar 15, 2024
P3, N=1200, Not yet recruiting, Sponsor: Merck Sharp & Dohme LLC
- |||||||||| sacituzumab tirumotecan (MK-2870) / Merck (MSD)
New P3 trial, Combination therapy, Metastases: 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) and Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009) (clinicaltrials.gov) - Mar 12, 2024
P3, N=520, Not yet recruiting, Sponsor: Merck Sharp & Dohme LLC
- sacituzumab tirumotecan (MK-2870) / Merck (MSD)
Preliminary efficacy and safety results of anti-TROP2 ADC SKB264 (MK-2870) in patients (pts) with previously treated advanced gastric (G) or gastroesophageal junction (GEJ) cancer from a Phase 2 study (Hall GH - Ground Level - Convention Center) - Mar 5, 2024 - Abstract #AACR2024AACR_8743;
Not yet recruiting --> Recruiting Abstract is embargoed at this time.
- sacituzumab tirumotecan (MK-2870) / Merck (MSD), Keytruda (pembrolizumab) / Merck (MSD)
Phase 3 MK-2870-007 study: MK-2870 (SKB264) plus pembrolizumab vs pembrolizumab alone as first-line treatment for metastatic non-small-cell lung cancer with PD-L1 tumor proportion score (TPS) ?50% (Section 50) - Mar 5, 2024 - Abstract #AACR2024AACR_7914;
Abstract is embargoed at this time. Abstract is embargoed at this time.
- sacituzumab tirumotecan (MK-2870) / Merck (MSD)
MK-2870-004: A phase 3 study of MK-2870 (SKB264) versus chemotherapy for previously treated advanced or metastatic nonsquamous non-small-cell lung cancer (NSCLC) with EGFR mutations or other genomic alterations (Section 50) - Mar 5, 2024 - Abstract #AACR2024AACR_7913;
Abstract is embargoed at this time. Abstract is embargoed at this time.
- sacituzumab tirumotecan (MK-2870) / Merck (MSD)
Updated efficacy and safety of anti-TROP2 ADC SKB264 (MK-2870) for previously treated advanced NSCLC in Phase 2 study (Section 48) - Mar 5, 2024 - Abstract #AACR2024AACR_7881;
Abstract is embargoed at this time. Abstract is embargoed at this time.
- |||||||||| sacituzumab tirumotecan (MK-2870) / Merck (MSD)
New P3 trial, Metastases: SKB264-?-11: A Study of SKB264 Versus Investigator's Choice Chemotherapy in Patients With Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer (clinicaltrials.gov) - Feb 27, 2024
P3, N=524, Not yet recruiting, Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
- sacituzumab tirumotecan (MK-2870) / Merck (MSD)
Updated efficacy and safety of SKB264 (MK-2870) for previously treated metastatic triple negative breast cancer (mTNBC) in Phase 2 study () - Jan 22, 2024 - Abstract #YIR2024YIR_121;
P1/2, P2,
Higher response rate was seen in mTNBC pts with high TROP2 expression. A Phase 3 study of SKB264 vs.
- || Keytruda (pembrolizumab) / Merck (MSD)
Trial completion date, Trial primary completion date, Metastases: 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) (clinicaltrials.gov) - Jan 9, 2024
P1/2, N=200, Recruiting, Sponsor: Merck Sharp & Dohme LLC
A Phase 3 study of SKB264 vs. Trial completion date: Dec 2026 --> Sep 2028 | Trial primary completion date: Feb 2025 --> Nov 2026
- |||||| sacituzumab tirumotecan (MK-2870) / Merck (MSD), Keytruda (pembrolizumab) / Merck (MSD)
Enrollment open, Combination therapy, Monotherapy, Tumor proportion score, Metastases: 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) (clinicaltrials.gov) - Jan 4, 2024
P3, N=614, Recruiting, Sponsor: Merck Sharp & Dohme LLC
Trial completion date: Dec 2026 --> Sep 2028 | Trial primary completion date: Feb 2025 --> Nov 2026 Not yet recruiting --> Recruiting
- |||||| sacituzumab tirumotecan (MK-2870) / Merck (MSD)
Enrollment open, Monotherapy: Sacituzumab Tirumotecan (MK-2870) in Post Platinum and Post Immunotherapy Endometrial Cancer (MK-2870-005) (clinicaltrials.gov) - Dec 14, 2023
P3, N=710, Recruiting, Sponsor: Merck Sharp & Dohme LLC
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- |||||||||| sacituzumab tirumotecan (MK-2870) / Merck (MSD), Keytruda (pembrolizumab) / Merck (MSD)
New P3 trial, Combination therapy, Monotherapy, Tumor proportion score, Metastases: 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) (clinicaltrials.gov) - Dec 14, 2023
P3, N=614, Not yet recruiting, Sponsor: Merck Sharp & Dohme LLC
- | sacituzumab tirumotecan (MK-2870) / Merck (MSD)
Enrollment open, Trial completion date, Trial primary completion date, Combination therapy, Metastases: SKB264 Combinatiton Therapy in Patients With Advanced or Metastatic Non-small Cell Lung Cancer. (clinicaltrials.gov) - Dec 14, 2023
P2, N=110, Recruiting, Sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting | Trial completion date: Apr 2025 --> Apr 2026 | Trial primary completion date: Aug 2023 --> Aug 2024
- || sacituzumab tirumotecan (MK-2870) / Merck (MSD)
Phase classification, Monotherapy: Sacituzumab Tirumotecan (MK-2870) in Post Platinum and Post Immunotherapy Endometrial Cancer (MK-2870-005) (clinicaltrials.gov) - Dec 13, 2023
P3, N=710, Not yet recruiting, Sponsor: Merck Sharp & Dohme LLC
Not yet recruiting --> Recruiting | Trial completion date: Apr 2025 --> Apr 2026 | Trial primary completion date: Aug 2023 --> Aug 2024 Phase classification: P2/3 --> P3
- |||||| sacituzumab tirumotecan (MK-2870) / Merck (MSD)
Enrollment open, Metastases: 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) (clinicaltrials.gov) - Nov 18, 2023
P3, N=556, Recruiting, Sponsor: Merck Sharp & Dohme LLC
Phase classification: P2/3 --> P3 Not yet recruiting --> Recruiting
- ||| Keytruda (pembrolizumab) / Merck (MSD)
Enrollment change, Metastases: 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) (clinicaltrials.gov) - Nov 18, 2023
P1/2, N=200, Recruiting, Sponsor: Merck Sharp & Dohme LLC
Not yet recruiting --> Recruiting N=300 --> 200
- |||||||||| sacituzumab tirumotecan (MK-2870) / Merck (MSD)
New P2/3 trial, New P3 trial, Monotherapy: Sacituzumab Tirumotecan (MK-2870) in Post Platinum and Post Immunotherapy Endometrial Cancer (MK-2870-005) (clinicaltrials.gov) - Nov 15, 2023
P2/3, N=710, Not yet recruiting, Sponsor: Merck Sharp & Dohme LLC
- sacituzumab tirumotecan (MK-2870) / Merck (MSD)
Updated efficacy and safety of SKB264 (MK-2870) for previously treated metastatic triple negative breast cancer (mTNBC) in Phase 2 study (Hemisfair Ballroom 1-2) - Nov 4, 2023 - Abstract #SABCS2023SABCS_347;
P1/2, P2,
Higher response rate was seen in mTNBC pts with high TROP2 expression. A Phase 3 study of SKB264 vs.
- || sacituzumab tirumotecan (MK-2870) / Merck (MSD), Keytruda (pembrolizumab) / Merck (MSD)
Enrollment open, Combination therapy, Monotherapy, Metastases: MK-2870 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors (MK-2870-008) (clinicaltrials.gov) - Nov 3, 2023
P1, N=48, Recruiting, Sponsor: Merck Sharp & Dohme LLC
A Phase 3 study of SKB264 vs. Not yet recruiting --> Recruiting
- | sacituzumab tirumotecan (MK-2870) / Merck (MSD)
Enrollment open, Enrollment change, Monotherapy, Metastases: SKB264 Monotherapy in Selected Subjects With Advanced Solid Tumors (clinicaltrials.gov) - Oct 24, 2023
P2, N=366, Recruiting, Sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting | N=237 --> 366
- ||| sacituzumab tirumotecan (MK-2870) / Merck (MSD), tagitanlimab (HBM9167) / Harbour BioMed
Enrollment open, Enrollment change, Trial completion date, Trial primary completion date, Metastases: SKB264 +/- KL-A167 in Recurrent or Metastatic HER2-negative Breast Cancer (clinicaltrials.gov) - Oct 23, 2023
P2, N=175, Recruiting, Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Not yet recruiting --> Recruiting | N=237 --> 366 Not yet recruiting --> Recruiting | N=95 --> 175 | Trial completion date: Jul 2024 --> Jul 2025 | Trial primary completion date: Apr 2024 --> Apr 2025
- ||||| sacituzumab tirumotecan (MK-2870) / Merck (MSD)
Enrollment closed, Metastases: SKB264 Injection vs Investigator Selected Regimens to Treat Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer (clinicaltrials.gov) - Oct 23, 2023
P3, N=254, Active, not recruiting, Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Not yet recruiting --> Recruiting | N=95 --> 175 | Trial completion date: Jul 2024 --> Jul 2025 | Trial primary completion date: Apr 2024 --> Apr 2025 Not yet recruiting --> Active, not recruiting
- | sacituzumab tirumotecan (MK-2870) / Merck (MSD)
New P3 trial, Metastases: A Phase III Study of SKB264 for Locally Advanced, Recurrent or Metastatic HR+/HER2- Breast Cancer (clinicaltrials.gov) - Oct 13, 2023
P3, N=376, Not yet recruiting, Sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
- |||||||||| sacituzumab tirumotecan (MK-2870) / Merck (MSD)
New P3 trial, Metastases: 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) (clinicaltrials.gov) - Oct 9, 2023
P3, N=556, Not yet recruiting, Sponsor: Merck Sharp & Dohme LLC
- || sacituzumab tirumotecan (MK-2870) / Merck (MSD), Keytruda (pembrolizumab) / Merck (MSD)
New P1 trial, Combination therapy, Monotherapy, Metastases: MK-2870 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors (MK-2870-008) (clinicaltrials.gov) - Sep 22, 2023
P1, N=48, Not yet recruiting, Sponsor: Merck Sharp & Dohme LLC
- |||||| sacituzumab tirumotecan (MK-2870) / Merck (MSD)
Enrollment open, Combination therapy, Monotherapy, Metastases: A Phase III Study of SKB264 for EGFR Mutant NSCLC Patients (clinicaltrials.gov) - Aug 8, 2023
P3, N=356, Recruiting, Sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
Not yet recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- ||| sacituzumab tirumotecan (MK-2870) / Merck (MSD)
Enrollment open, Combination therapy, Pan tumor: SKB264 in Combination With Pembrolizumab in Subjects With Selected Solid Tumors (clinicaltrials.gov) - Aug 4, 2023
P2, N=184, Recruiting, Sponsor: Klus Pharma Inc.
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- MK-2870 / Merck (MSD)
SKB264 (MK-2870) in previously treated hormone receptor-positive (HR+)/ HER2-negative metastatic breast cancer (mBC): Results from a phase I/II, single-arm, basket trial (Bilbao Auditorium - NCC) - Jul 27, 2023 - Abstract #ESMO2023ESMO_791;
P1/2
Conclusions SKB264 at 5 mg/kg demonstrates a manageable safety profile and promising antitumor activity in pts with pre-treated HR+/HER2- mBC. Two phase 3 studies are currently planned in HR+/HER2- mBC, one in China for pts after at least one chemo for mBC and a second global for pts previously untreated with chemo for mBC, both comparing SKB264 vs investigator selected chemo.
- |||||||||| sacituzumab tirumotecan (MK-2870) / Merck (MSD)
New P3 trial, Combination therapy, Monotherapy, Metastases: A Phase III Study of SKB264 for EGFR Mutant NSCLC Patients (clinicaltrials.gov) - May 23, 2023
P3, N=356, Not yet recruiting, Sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
- |||| sacituzumab tirumotecan (MK-2870) / Merck (MSD)
Enrollment open, Combination therapy, Monotherapy, Metastases: A Study of SKB264 for the Treatment of Participants With Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov) - May 16, 2023
P2, N=296, Recruiting, Sponsor: Klus Pharma Inc.
Two phase 3 studies are currently planned in HR+/HER2- mBC, one in China for pts after at least one chemo for mBC and a second global for pts previously untreated with chemo for mBC, both comparing SKB264 vs investigator selected chemo. Not yet recruiting --> Recruiting
- MK-2870 / Merck (MSD)
SKB264 (TROP2-ADC) for the treatment of patients with advanced NSCLC: Efficacy and safety data from a phase 2 study. (On Demand | Hall A; Poster Bd # 102) - Apr 26, 2023 - Abstract #ASCO2023ASCO_3523;
P1/2
TRAEs were mainly hematologic. Phase 3 studies of SKB264 in pts with advanced NSCLC have been planned.
- ||||| sacituzumab tirumotecan (MK-2870) / Merck (MSD)
New P2 trial, Combination therapy, Monotherapy, Metastases: A Study of SKB264 for the Treatment of Participants With Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov) - Apr 18, 2023
P2, N=296, Not yet recruiting, Sponsor: Klus Pharma Inc.
- || Keytruda (pembrolizumab) / Merck (MSD)
Trial primary completion date, Metastases: 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) (clinicaltrials.gov) - Mar 20, 2023
P1/2, N=300, Recruiting, Sponsor: Merck Sharp & Dohme LLC
Phase 3 studies of SKB264 in pts with advanced NSCLC have been planned. Trial primary completion date: May 2025 --> Feb 2025
- SHR-A1921 / Jiangsu Hengrui Pharma
SHR-A1921, a novel TROP-2 ADC with an optimized design and well-balanced profile between efficacy and safety (Section 35; Poster Board #22) - Mar 14, 2023 - Abstract #AACR2023AACR_2086;
P1
#. non-head-to-head comparison.)
- |||| Keytruda (pembrolizumab) / Merck (MSD)
Enrollment open, Metastases: 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) (clinicaltrials.gov) - Feb 2, 2023
P1/2, N=300, Recruiting, Sponsor: Merck Sharp & Dohme LLC
non-head-to-head comparison.) Not yet recruiting --> Recruiting
- | MK-2870 / Merck (MSD), Camtobell (belotecan) / Equisnzaroo
Nice summary! MK-2870/SKB-264 payload is not belotecan but a belotecan derivative (named KL610023 or T030)(https://t.co/JoV6eRa2Ko) Also a new TROP2 ADC (FZ-AD004) should enter phase 1 in China soon (https://t.co/VmzDmptZcS) (Twitter) - Jan 20, 2023
- | MK-2870 / Merck (MSD), Trodelvy (sacituzumab govitecan-hziy) / Everest Medicines, Gilead
Preclinical, Journal: Preclinical profiles of SKB264, a novel anti-TROP2 antibody conjugated to topoisomerase inhibitor, demonstrated promising antitumor efficacy compared to IMMU-132. (Pubmed Central) - Jan 10, 2023
At the same dose, SKB264's exposure in tumor tissue was 4.6-fold higher than that of IMMU-132. Compared with IMMU-132, the longer half-life of SKB264 had a stronger targeting effect and better antitumor activity, suggesting the better therapeutic potential of SKB264 for treating TROP2-positive tumors.
- |||| sacituzumab tirumotecan (MK-2870) / Merck (MSD)
New P2 trial, Combination therapy, Pan tumor: SKB264 in Combination With Pembrolizumab in Subjects With Selected Solid Tumors (clinicaltrials.gov) - Dec 8, 2022
P2, N=184, Not yet recruiting, Sponsor: Klus Pharma Inc.
- | sacituzumab tirumotecan (MK-2870) / Merck (MSD)
New P2 trial, Monotherapy, Metastases: SKB264 Monotherapy in Selected Subjects With Advanced Solid Tumors (clinicaltrials.gov) - Nov 30, 2022
P2, N=237, Not yet recruiting, Sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
- ||| sacituzumab tirumotecan (MK-2870) / Merck (MSD)
Enrollment change, Metastases: Phase I-II, FIH, TROP2 ADC, Advanced Unresectable/Metastatic Solid Tumors, Refractory to Standard Therapies (clinicaltrials.gov) - Nov 28, 2022
P1/2, N=430, Recruiting, Sponsor: Klus Pharma Inc.
Compared with IMMU-132, the longer half-life of SKB264 had a stronger targeting effect and better antitumor activity, suggesting the better therapeutic potential of SKB264 for treating TROP2-positive tumors. N=250 --> 430
- SKB264 / Merck (MSD)
Efficacy and safety of SKB264 for previously treated metastatic triple negative breast cancer in Phase 2 study (Hall 1) - Oct 10, 2022 - Abstract #SABCS2022SABCS_1637;
P1/2, P3
SKB264 toxicity was mainly hematologic. A Phase 3 study of SKB264 vs investigator selected chemo alone in pts with locally advanced inoperable or metastatic TNBC was initiated (NCT05347134).
- | SKB-315 / Sichuan Kelun Pharma, SKB264 / Merck (MSD), Camtobell (belotecan) / Equisnzaroo
$MRK 2nd licensed ADC from Kelun likely Claudin18.2 (SKB315) as well, utilizing same belotecan-derived payload as $MRK previously licensed only now disclosed TROP2 ADC SKB264. (Twitter) - Jul 29, 2022