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DRUG CLASS:

TIM-3 antagonist

23d
A Study of Cobolimab Plus Dostarlimab in Pediatric and Young Adult Participants With Cancer (clinicaltrials.gov)
P1/2, N=83, Active, not recruiting, GlaxoSmithKline | Trial completion date: Jan 2032 --> Oct 2026 | Trial primary completion date: Jan 2032 --> Oct 2026
Trial completion date • Trial primary completion date
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Jemperli (dostarlimab-gxly) • cobolimab (TSR-022)
1m
A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER) (clinicaltrials.gov)
P1, N=463, Active, not recruiting, Tesaro, Inc. | Recruiting --> Active, not recruiting | Trial primary completion date: Apr 2025 --> Mar 2027
Enrollment closed • Trial primary completion date
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Opdivo (nivolumab) • cisplatin • carboplatin • docetaxel • pemetrexed • Jemperli (dostarlimab-gxly) • cobolimab (TSR-022) • encelimab (TSR-033)
2ms
Study of Niraparib, TSR-022, Bevacizumab, and Platinum-Based Doublet Chemotherapy in Combination With TSR-042 (clinicaltrials.gov)
P1, N=60, Completed, Tesaro, Inc. | Active, not recruiting --> Completed | Trial completion date: Aug 2024 --> Dec 2024
Trial completion • Trial completion date
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Keytruda (pembrolizumab) • Avastin (bevacizumab) • carboplatin • Zejula (niraparib) • albumin-bound paclitaxel • pemetrexed • Jemperli (dostarlimab-gxly) • cobolimab (TSR-022)
2ms
MBG453 in Lower Risk MDS (clinicaltrials.gov)
P2, N=20, Active, not recruiting, Massachusetts General Hospital | Recruiting --> Active, not recruiting | Trial completion date: Jan 2026 --> Nov 2026 | Trial primary completion date: Jun 2024 --> Nov 2024
Enrollment closed • Trial completion date • Trial primary completion date
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Chr del(5q)
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sabatolimab (MBG453)
2ms
Trial completion date
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docetaxel • Jemperli (dostarlimab-gxly) • cobolimab (TSR-022)
3ms
Trial of Anti-Tim-3 in Combination With Anti-PD-1 and SRS in Recurrent GBM (clinicaltrials.gov)
P1, N=16, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Sep 2025 --> Sep 2026
Trial completion date
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MGMT (6-O-methylguanine-DNA methyltransferase)
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spartalizumab (PDR001) • sabatolimab (MBG453)
4ms
Elevated TIM3 expression on bone marrow T cells drives immune dysfunction in early relapsed blood cancer after allogeneic hematopoietic stem cell transplantation. (PubMed, Exp Hematol Oncol)
Functional assays demonstrated that TIM3 blockade with sabatolimab restored T cell cytotoxicity, leading to enhanced leukemia cell apoptosis in ER patients. These findings highlight TIM3 as a critical regulator of T cell exhaustion and immune suppression in patients with ER and provide a rationale for the therapeutic use of TIM3 blockade in preventing and treating relapses after allo-HSCT.
Journal
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ER (Estrogen receptor) • HAVCR2 (Hepatitis A Virus Cellular Receptor 2)
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sabatolimab (MBG453)
4ms
A Study of Cobolimab Plus Dostarlimab in Pediatric and Young Adult Participants With Cancer (clinicaltrials.gov)
P1/2, N=95, Active, not recruiting, GlaxoSmithKline | Trial primary completion date: Oct 2029 --> Jan 2032 | Recruiting --> Active, not recruiting
Enrollment closed • Trial primary completion date
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Jemperli (dostarlimab-gxly) • cobolimab (TSR-022)
4ms
STIMULUS MDS-US : Sabatolimab Added to HMA in Higher Risk MDS (clinicaltrials.gov)
P2, N=39, Terminated, Novartis Pharmaceuticals | Completed --> Terminated; Lack of efficacy in the program as demonstrated in the earlier CMBG453B12301 (STIMULUS MDS-2) study.
Trial termination
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azacitidine • decitabine • Inqovi (decitabine/cedazuridine) • sabatolimab (MBG453)
5ms
Combined Targeting of PD-1 and TIM-3 in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer: AMBER Part 2B. (PubMed, Clin Cancer Res)
Cobolimab plus dostarlimab showed preliminary efficacy and tolerability in a subset of patients with locally advanced/metastatic NSCLC. See related article by Davar et al., p. XX.
Journal • PD(L)-1 Biomarker • IO biomarker
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PD-1 (Programmed cell death 1) • HAVCR2 (Hepatitis A Virus Cellular Receptor 2)
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Jemperli (dostarlimab-gxly) • cobolimab (TSR-022)
5ms
Combined Targeting of PD-1 and TIM-3 in Patients with Locally Advanced or Metastatic Melanoma: AMBER Cohorts 1c, 1e, and 2A. (PubMed, Clin Cancer Res)
In this exploratory setting, cobolimab plus dostarlimab was well tolerated, with reported preliminary efficacy similar to other anti-T-cell immunoglobulin and mucin-domain containing protein-3 treatments in patients with locally advanced/metastatic melanoma. See related article by Davar et al., p. XX.
Journal
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PD-1 (Programmed cell death 1) • HAVCR2 (Hepatitis A Virus Cellular Receptor 2)
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Jemperli (dostarlimab-gxly) • cobolimab (TSR-022)
6ms
STIMULUS-AML2: Sabatolimab as a Treatment for Patients With Acute Myeloid Leukemia and Presence of Measurable Residual Disease After Allogeneic Stem Cell Transplantation. (clinicaltrials.gov)
P1/2, N=24, Terminated, Novartis Pharmaceuticals | Completed --> Terminated; Study was stopped following a strategic decision from the Sponsor. It was not based on any safety findings or safety concerns with sabatolimab.
Trial termination
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azacitidine • sabatolimab (MBG453)