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- 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
- || sacituzumab tirumotecan (MK-2870) / Merck (MSD)
Trial completion date, Trial primary completion date, Metastases: KL264-01: Phase I-II, FIH, TROP2 ADC, Advanced Unresectable/Metastatic Solid Tumors, Refractory to Standard Therapies (clinicaltrials.gov) - Jul 12, 2022
P1/2, N=250, Recruiting, Sponsor: Klus Pharma Inc.
A Phase 3 study of SKB264 vs investigator selected chemo alone in pts with locally advanced inoperable or metastatic TNBC was initiated (NCT05347134). Trial completion date: Dec 2022 --> Dec 2025 | Trial primary completion date: Nov 2022 --> Nov 2024
- | sacituzumab tirumotecan (MK-2870) / Merck (MSD), tagitanlimab (HBM9167) / Harbour BioMed
New P2 trial, Metastases: SKB264 +/- KL-A167 in Recurrent or Metastatic HER2-negative Breast Cancer (clinicaltrials.gov) - Jul 5, 2022
P2, N=95, Not yet recruiting, Sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
- | sacituzumab tirumotecan (MK-2870) / Merck (MSD)
New P2 trial, Combination therapy, Metastases: SKB264 Combinatiton Therapy in Patients With Advanced or Metastatic Non-small Cell Lung Cancer. (clinicaltrials.gov) - Apr 28, 2022
P2, N=110, Not yet recruiting, Sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
- | sacituzumab tirumotecan (MK-2870) / Merck (MSD)
New P3 trial, Metastases: SKB264 Injection vs Investigator Selected Regimens to Treat Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer (clinicaltrials.gov) - Apr 25, 2022
P3, N=254, Not yet recruiting, Sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
- ||||| Keytruda (pembrolizumab) / Merck (MSD)
New P1/2 trial, 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) - Apr 8, 2022
P1/2, N=300, Not yet recruiting, Sponsor: Merck Sharp & Dohme Corp.
- || sacituzumab tirumotecan (MK-2870) / Merck (MSD)
Trial primary completion date, Metastases: KL264-01: Phase I-II, FIH, TROP2 ADC, Advanced Unresectable/Metastatic Solid Tumors, Refractory to Standard Therapies (clinicaltrials.gov) - Mar 29, 2022
P1/2, N=250, Recruiting, Sponsor: Klus Pharma Inc.
Trial completion date: Dec 2022 --> Dec 2025 | Trial primary completion date: Nov 2022 --> Nov 2024 Trial primary completion date: Feb 2022 --> Nov 2022
- Camtobell (belotecan) / Equisnzaroo
[VIRTUAL] An open-label, global, first-in-human study of SKB264 in patients with locally advanced or metastatic solid tumors (Channel 7) - Jul 22, 2021 - Abstract #ESMO2021ESMO_1014;
P1/2
SKB264 has demonstrated encouraging safety and antitumor activity. Study continues to identify dose(s) of SKB264.
- ||| sacituzumab tirumotecan (MK-2870) / Merck (MSD)
Enrollment change, Metastases: KL264-01: Phase I-II, FIH, TROP2 ADC, Advanced Unresectable/Metastatic Solid Tumors, Refractory to Standard Therapies (clinicaltrials.gov) - Jun 25, 2021
P1/2, N=250, Recruiting, Sponsor: Klus Pharma Inc.
Study continues to identify dose(s) of SKB264. N=78 --> 250
- Camtobell (belotecan) / OnKor
[VIRTUAL] SKB264 ADC: A first-in-human study of SKB264 in patients with locally advanced unresectable/metastatic solid tumors who are refractory to available standard therapies. (Poster Board 389) - Apr 29, 2020 - Abstract #ASCO2020ASCO_1606;
P1/2
The enrollment will began in Mar 2020 in USA sites. Research Funding: KLUS Pharm Inc.
- ||| sacituzumab tirumotecan (MK-2870) / Merck (MSD)
Enrollment open, Metastases: KL264-01: Phase I-II, FIH, TROP2 ADC, Advanced Unresectable/Metastatic Solid Tumors, Refractory to Standard Therapies (clinicaltrials.gov) - Mar 26, 2020
P1/2, N=78, Recruiting, Sponsor: Klus Pharma Inc.
Research Funding: KLUS Pharm Inc. Not yet recruiting --> Recruiting
- |||| sacituzumab tirumotecan (MK-2870) / Merck (MSD)
New P1/2 trial, Metastases: KL264-01: Phase I-II, FIH, TROP2 ADC, Advanced Unresectable/Metastatic Solid Tumors, Refractory to Standard Therapies (clinicaltrials.gov) - Nov 14, 2019
P1/2, N=78, Not yet recruiting, Sponsor: Klus Pharma Inc.