dostarlimab
Trade name: Jemperli
mAbapprovedBreakthrough Therapy FDA
Approved
Apr 22, 2021
Dostarlimab, sold under the brand name Jemperli, is a monoclonal antibody used as an anti-cancer medication for the treatment of endometrial cancer. Dostarlimab is a programmed death receptor-1 (PD-1)–blocking monoclonal antibody. — Wikipedia
Clinical trial activity
80 trials · 62 clinical orgs · 1 marketing orgs
Phase 1
21
Phase 2
66
Phase 3
11
Phase 4
1
Earliest trial started Jan 1, 2012 (NCT02248298)
Timeline
2010s
2020s
- Apr 22, 2021
GlaxoSmithKline — Earliest FDA Approval
- Apr 22, 2021
GlaxoSmithKline — Marketing Organization
- Apr 22, 2021
GlaxoSmithKline — NDA Secondary Org
- Apr 22, 2021
GlaxoSmithKline — NDA Organization
Indications
Studied for
- Adenocarcinoma · Phase 2
- Adenocarcinoma, Clear Cell · Phase 2
- Adrenocortical Carcinoma · Phase 2
- Biliary Tract Neoplasms · Phase 2
- Brain Neoplasms · Phase 2
- BRCA1 Protein · Phase 2
- Breast Neoplasms · Phase 2
- Carcinoma · Phase 2
- Carcinoma, Hepatocellular · Phase 1/Phase 2
- Carcinoma, Neuroendocrine · Phase 2
- Carcinoma, Non-Small-Cell Lung · Phase 3
- Carcinoma, Renal Cell · Phase 2
- Carcinoma, Transitional Cell · Phase 2
- Cholangiocarcinoma · Phase 2
- Colonic Neoplasms · Phase 3
- Colorectal Neoplasms · Phase 2
- Deficiency Diseases · Phase 2
- Diffuse Intrinsic Pontine Glioma · Phase 1/Phase 2
- Drug-Related Side Effects and Adverse Reactions · Phase 2
- Endometrial Neoplasms · Phase 3
- Ependymoma · Phase 1/Phase 2
- Esophageal Neoplasms · Phase 2
- Fallopian Tube Neoplasms · Phase 2
- Genital Neoplasms, Female · Phase 1/Phase 2
- Gestational Trophoblastic Disease · Phase 2
- Glioblastoma · Phase 1/Phase 2
- Glioma · Phase 1/Phase 2
- Hamartoma · Phase 2
- Head and Neck Neoplasms · Phase 3
- Hepatoblastoma · Phase 1/Phase 2
- HIV · Phase 1
- Hodgkin Disease · Phase 1/Phase 2
- Homologous Recombination · Phase 2
- Keratosis, Actinic · Phase 1
- Liver Neoplasms · Phase 2
- Lung Neoplasms · Phase 2
- Melanoma · Phase 2
- Mesothelioma · Phase 2
- Multiple Myeloma · Phase 1/Phase 2
- Mutation · Phase 2
- Neoplasm Metastasis · Phase 1
- Neoplasms · Phase 3
- Neoplasms, Second Primary · Phase 2
- Osteosarcoma · Phase 1/Phase 2
- Ovarian Diseases · Phase 2/Phase 3
- Ovarian Neoplasms · Phase 3
- Pancreatic Neoplasms · Phase 2
- Penile Neoplasms · Phase 2
- Rectal Neoplasms · Phase 2
- Rhabdomyosarcoma · Phase 1/Phase 2
- Sarcoma · Phase 2
- Sarcoma, Clear Cell · Phase 2
- Small Cell Lung Carcinoma · Phase 2
- Squamous Cell Carcinoma of Head and Neck · Phase 1/Phase 2
- Stomach Neoplasms · Phase 2
- Triple Negative Breast Neoplasms · Phase 2
- Uterine Cervical Neoplasms · Phase 2
- Uterine Neoplasms · Phase 1/Phase 2
- Vaginal Neoplasms · Phase 2
- Vulvar Neoplasms · Phase 2
Mechanism of action
- Programmed cell death protein 1ANTAGONIST
Programmed cell death protein 1 antagonist
- 80S RibosomeINHIBITOR
80S Ribosome inhibitor
- 60S ribosomal protein L39 (RPL39) ↗
- 60S ribosomal protein L41 (RPL41) ↗
- 40S ribosomal protein S15 (RPS15) ↗
- 40S ribosomal protein S15a (RPS15A) ↗
- 40S ribosomal protein S16 (RPS16) ↗
- 40S ribosomal protein S17 (RPS17) ↗
- 40S ribosomal protein SA (RPSA) ↗
- 40S ribosomal protein S18 (RPS18) ↗
- 40S ribosomal protein S19 (RPS19) ↗
- 40S ribosomal protein S20 (RPS20) ↗
- 40S ribosomal protein S21 (RPS21) ↗
- 40S ribosomal protein S23 (RPS23) ↗
- 40S ribosomal protein S24 (RPS24) ↗
- 40S ribosomal protein S25 (RPS25) ↗
- 40S ribosomal protein S27 (RPS27) ↗
- 40S ribosomal protein S26 (RPS26) ↗
- Ubiquitin-40S ribosomal protein S27a (RPS27A) ↗
- 40S ribosomal protein S28 (RPS28) ↗
- 40S ribosomal protein S29 (RPS29) ↗
- 40S ribosomal protein S30 (RS30) ↗
- 60S ribosomal protein L21 (RPL21) ↗
- 60S ribosomal protein L22 (RPL22) ↗
- 60S ribosomal protein L23 (RPL23) ↗
- 60S ribosomal protein L23a (RPL23A) ↗
- 60S ribosomal protein L24 (RPL24) ↗
- 40S ribosomal protein S6 (RPS6) ↗
- 60S ribosomal protein L26 (RPL26) ↗
- 60S ribosomal protein L27 (RPL27) ↗
- 60S ribosomal protein L27a (RPL27A) ↗
- 60S ribosomal protein L28 (RPL28) ↗
- 60S ribosomal protein L29 (RPL29) ↗
- 60S ribosomal protein L30 (RPL30) ↗
- 60S ribosomal protein L31 (RPL31) ↗
- 60S ribosomal protein L32 (RPL32) ↗
- 60S ribosomal protein L34 (RPL34) ↗
- 60S ribosomal protein L35 (RPL35) ↗
- 60S ribosomal protein L35a (RPL35A) ↗
- 60S ribosomal protein L36 (RPL36) ↗
- 60S ribosomal protein L36a (RPL36A) ↗
- 60S ribosomal protein L37 (RPL37) ↗
- 40S ribosomal protein S10 (RPS10) ↗
- 40S ribosomal protein S11 (RPS11) ↗
- 40S ribosomal protein S12 (RPS12) ↗
- 40S ribosomal protein S13 (RPS13) ↗
- 40S ribosomal protein S14 (RPS14) ↗
- 60S ribosomal protein L37a (RPL37A) ↗
- 40S ribosomal protein S2 (RPS2) ↗
- 40S ribosomal protein S3 (RPS3) ↗
- 40S ribosomal protein S3a (RPS3A) ↗
- 40S ribosomal protein S4, X isoform (RPS4X) ↗
- 40S ribosomal protein S4, Y isoform 1 (RPS4Y1) ↗
- 40S ribosomal protein S5 (RPS5) ↗
- 40S ribosomal protein S7 (RPS7) ↗
- 40S ribosomal protein S8 (RPS8) ↗
- 40S ribosomal protein S9 (RPS9) ↗
- 60S ribosomal protein L3 (RPL3) ↗
- 60S ribosomal protein L4 (RPL4) ↗
- 60S ribosomal protein L5 (RPL5) ↗
- 60S ribosomal protein L6 (RPL6) ↗
- 60S ribosomal protein L7 (RPL7) ↗
- 60S ribosomal protein L7a (RPL7A) ↗
- 60S ribosomal protein L8 (RPL8) ↗
- 60S ribosomal protein L9 (RPL9; RPL9P7; RPL9P8; RPL9P9) ↗
- 60S ribosomal protein L10 (RPL10) ↗
- 60S ribosomal protein L10a (RPL10A) ↗
- 60S ribosomal protein L11 (RPL11) ↗
- 60S ribosomal protein L12 (RPL12) ↗
- 60S ribosomal protein L13 (RPL13) ↗
- 60S ribosomal protein L13a (RPL13A) ↗
- 60S ribosomal protein L14 (RPL14) ↗
- 60S ribosomal protein L15 (RPL15) ↗
- 60S ribosomal protein L17 (RPL17) ↗
- 60S ribosomal protein L18 (RPL18) ↗
- 60S ribosomal protein L18a (RPL18A) ↗
- 60S ribosomal protein L19 (RPL19) ↗
- 60S ribosomal protein L38 (RPL38) ↗
- 60S acidic ribosomal protein P0 (RPLP0) ↗
- 60S acidic ribosomal protein P1 (RPLP1) ↗
Approval history
- approvedPriority reviewAcceleratedBreakthroughApr 22, 2021
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaDostarlimab ↗
- ChEMBLCHEMBL4298124 ↗
- WikipediaGarnet ↗
Also known as
- garnet
- garnet
- tsr-042
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07108270 | Phase 2 | Nov 30, 2025 | GlaxoSmithKline |
| NCT07013851 | Phase 2 | Oct 1, 2025 | GlaxoSmithKline, Grupo Español de Investigación en Cáncer de Ovario |
| NCT07115927 | Phase 2 | Sep 30, 2025 | GlaxoSmithKline, University of London |
| NCT06897527 | Phase 4 | Jul 15, 2025 | GlaxoSmithKline |
| NCT06879717 | Phase 1/Phase 2 (Phase 2) | Apr 30, 2025 | iOnctura |
| NCT06830239 | Phase 2 | Mar 31, 2025 | Katholieke Universiteit Leuven |
| NCT06796907 | Phase 1/Phase 2 (Phase 2) | Mar 4, 2025 | GlaxoSmithKline |
| NCT06762405 | Phase 3 | Feb 6, 2025 | University of Burgundy |
| NCT06757244 | Phase 2 | Jan 15, 2025 | GlaxoSmithKline, Hôpital FOCH, University of Versailles |
| NCT06567782 | Phase 2 | Dec 5, 2024 | GlaxoSmithKline |
| NCT06365970 | Phase 2 | Oct 31, 2024 | GlaxoSmithKline, University of Pittsburgh |
| NCT06640049 | Phase 2 | Oct 17, 2024 | GlaxoSmithKline |
| NCT06521567 | Phase 1/Phase 2 (Phase 2) | Sep 13, 2024 | GlaxoSmithKline |
| NCT06405230 | Phase 1/Phase 2 (Phase 2) | Aug 15, 2024 | GlaxoSmithKline |
| NCT06333314 | Phase 2 | Jul 23, 2024 | GlaxoSmithKline, National Cancer Institute, France, UNICANCER |
| NCT06472076 | Phase 3 | Jun 10, 2024 | GlaxoSmithKline, iTeos Therapeutics |
| NCT06278857 | Phase 2 | Jun 1, 2024 | GlaxoSmithKline, University of Queensland |
| NCT06385548 | Phase 1/Phase 2 (Phase 2) | May 31, 2024 | Universidad Autonoma de Barcelona |
| NCT06317311 | Phase 2 | May 7, 2024 | GlaxoSmithKline |
| NCT06256588 | Phase 3 | Mar 21, 2024 | GlaxoSmithKline |
Showing 20 of 80 trials
Page 1 / 4
Organizations
Research & Development (62)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| GlaxoSmithKline | For profit | 43 | 21 | 4 | 2018 |
| Tesaro | For profit | 17 | 8 | 3 | 2016 |
| Harvard University | Academic/Hospital | 4 | 4 | 1 | 2020 |
| University of Texas at Houston | Academic/Hospital | 4 | 4 | 2 | 2021 |
| iTeos Therapeutics | For profit | 3 | 0 | 2 | 2022 |
| ARCAGY-GINECO | For profit | 2 | 2 | 1 | 2019 |
| European Network for Gynaecological Oncological Trial | Academic/Hospital | 2 | 0 | 1 | 2018 |
| Grupo Español de Investigación en Cáncer de Ovario | Academic/Hospital | 2 | 2 | 1 | 2019 |
| Gynecologic Oncology Group | Academic/Hospital | 2 | 0 | 2 | 2019 |
| Memorial Sloan-Kettering Cancer Center | Academic/Hospital | 2 | 2 | 1 | 2019 |
| Universidad Autonoma de Barcelona | Academic/Hospital | 2 | 1 | 1 | 2019 |
| University of Iowa | Academic/Hospital | 2 | 2 | 1 | 2021 |
| University of Pittsburgh | Academic/Hospital | 2 | 2 | 1 | 2019 |
| 23andMe, Inc. | For profit | 1 | 0 | 1 | 2020 |
| AGO Germany | Academic/Hospital | 1 | 1 | 1 | 2022 |
| Apices Soluciones S.L. | For profit | 1 | 0 | 1 | 2019 |
| Centre Leon Berard | Academic/Hospital | 1 | 1 | 1 | 2023 |
| Dong-A University | Academic/Hospital | 1 | 1 | 1 | 2012 |
| Duke University | Academic/Hospital | 1 | 0 | 1 | 2021 |
| Emory University | Academic/Hospital | 1 | 0 | 1 | 2021 |
62 organizations
Page 1 / 4
Marketing (4)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| GlaxoSmithKline | For profit | MKTG | Apr 22, 2021 |
| GlaxoSmithKline | For profit | SYN | Aug 17, 2021 |
| GlaxoSmithKline | For profit | NDA2 | Apr 22, 2021 |
| GlaxoSmithKline | For profit | NDA | Apr 22, 2021 |