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our Premium Content: News alerts, weekly reports and conference plannersDRUG:
lorigerlimab (MGD019)
i
Other names: MGD019
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News alerts, weekly reports and conference planners
Company:
MacroGenics
Drug class:
PD1 inhibitor, CTLA4 inhibitor
Related drugs:
1m
A Study of MGC018 in Combination With MGD019 in Participants With Advanced Solid Tumors (clinicaltrials.gov)
P1, N=278, Recruiting, MacroGenics | Trial completion date: Mar 2025 --> Mar 2026 | Trial primary completion date: Mar 2024 --> Mar 2025
Trial completion date • Trial primary completion date • Combination therapy • Checkpoint inhibition • Metastases
|
vobramitamab duocarmazine (MGC018) • lorigerlimab (MGD019)
2ms
MGD019 DART® Protein in Unresectable/Metastatic Cancer (clinicaltrials.gov)
P1, N=162, Active, not recruiting, MacroGenics | Trial completion date: Sep 2024 --> Dec 2024 | Trial primary completion date: Mar 2024 --> Jul 2024
Trial completion date • Trial primary completion date • Metastases
|
BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MSI (Microsatellite instability) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
EGFR mutation • BRAF mutation • EGFR T790M • ALK rearrangement • ROS1 rearrangement
|
lorigerlimab (MGD019)
5ms
LORIKEET: A phase 2, randomized, open-label study of lorigerlimab plus docetaxel versus docetaxel alone in patients with metastatic castration-resistant prostate cancer (mCRPC). (ASCO-GU 2024)
Key eligibility criteria include age ³ 18; ECOG performance status 0 or 1; disease progression by PCWG3 criteria following prior androgen receptor axis-targeted therapy (e.g., abiraterone, enzalutamide, apalutamide); no prior taxane chemotherapy for mCRPC;immune checkpoint inhibitors. Petrylak, ASCO-GU 2023, Abstract 19. Clinical trial information: NCT05848011.
Clinical • P2 data • Metastases
|
docetaxel • Xtandi (enzalutamide capsule) • abiraterone acetate • Erleada (apalutamide) • lorigerlimab (MGD019)
5ms
A Study of Lorigerlimab With Docetaxel or Docetaxel Alone in Participants With Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
P2, N=150, Recruiting, MacroGenics
Trial completion date • Trial primary completion date • Metastases
|
BRCA (Breast cancer early onset)
|
BRCA mutation
|
docetaxel • lorigerlimab (MGD019)
6ms
MGD019 DART® Protein in Unresectable/Metastatic Cancer (clinicaltrials.gov)
P1, N=162, Active, not recruiting, MacroGenics | Trial completion date: Apr 2024 --> Sep 2024 | Trial primary completion date: Oct 2023 --> Mar 2024
Trial completion date • Trial primary completion date • Metastases
|
BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MSI (Microsatellite instability) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
EGFR mutation • BRAF mutation • EGFR T790M • ALK rearrangement • ROS1 rearrangement
|
lorigerlimab (MGD019)
7ms
A Study of Lorigerlimab With Docetaxel or Docetaxel Alone in Participants With Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
P2, N=150, Recruiting, MacroGenics | Not yet recruiting --> Recruiting
Enrollment open • Metastases
|
BRCA (Breast cancer early onset)
|
BRCA mutation
|
docetaxel • lorigerlimab (MGD019)
9ms
Novel agents and clinical trials in castration-resistant prostate cancer: latest updates from 2023 ASCO-GU Cancers Symposium. (PubMed, Exp Hematol Oncol)
Notably, radionuclide drug conjugates (RDC), specifically 177Lu/111In-J591 and 225Ac-J591, exhibited enhanced therapeutic efficacy in treating patients with CRPC. Furthermore, promising treatment approaches for CRPC included dual anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) and anti-programmed death-1 (PD-1) blockade in rare tumors (DART)-Lorigerlimab, prostate stem cell antigen (PSCA)-directed chimeric antigen receptor (CAR)-T cell immunotherapy-BPX-601, and protein kinase inhibitor (AKTi)-CAPltello-280. We have summarized the latest CRPC treatment strategies presented at the 2023 ASCO-GU Cancers Symposium, along with recent advances in CRPC clinical trials.
Journal
|
CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • PSCA (Prostate Stem Cell Antigen 2)
|
BPX-601 • lorigerlimab (MGD019) • rosopatamab-225Ac (CONV01-α)
12ms
A Study of Lorigerlimab With Docetaxel or Docetaxel Alone in Participants With Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
P2, N=150, Not yet recruiting, MacroGenics
New P2 trial
|
BRCA (Breast cancer early onset)
|
BRCA mutation
|
docetaxel • lorigerlimab (MGD019)
1year
MGD019 DART® Protein in Unresectable/Metastatic Cancer (clinicaltrials.gov)
P1, N=162, Active, not recruiting, MacroGenics | N=287 --> 162 | Trial completion date: Dec 2023 --> Apr 2024 | Trial primary completion date: Jun 2023 --> Oct 2023
Enrollment change • Trial completion date • Trial primary completion date • Metastases
|
BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MSI (Microsatellite instability) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
EGFR mutation • BRAF mutation • EGFR T790M • ALK rearrangement • ROS1 rearrangement
|
lorigerlimab (MGD019)
over1year
MGD019 DART® Protein in Unresectable/Metastatic Cancer (clinicaltrials.gov)
P1, N=287, Active, not recruiting, MacroGenics | Trial completion date: Jun 2023 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Jun 2023
Trial completion date • Trial primary completion date • Metastases
|
BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MSI (Microsatellite instability) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
EGFR mutation • BRAF mutation • EGFR T790M • ALK rearrangement • ROS1 rearrangement
|
lorigerlimab (MGD019)
over1year
Lorigerlimab, a bispecific PD-1×CTLA-4 DART molecule in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC): A phase 1 expansion (exp) cohort. (ASCO-GU 2023)
Lorigerlimab demonstrates a manageable safety profile with evidence of encouraging and durable antitumor activity in a chemotherapy refractory mCRPC population. Randomized evaluation of lorigerlimab in mCRPC is warranted. Clinical trial information: NCT03761017.
Clinical • P1 data • PD(L)-1 Biomarker • IO biomarker • Metastases
|
PD-1 (Programmed cell death 1) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • ICOS (Inducible T Cell Costimulator)
|
PD-1 expression • CTLA4 expression
|
lorigerlimab (MGD019)
almost2years
MGD019 DART® Protein in Unresectable/Metastatic Cancer (clinicaltrials.gov)
P1, N=287, Active, not recruiting, MacroGenics | Recruiting --> Active, not recruiting
Enrollment closed
|
EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MSI (Microsatellite instability) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
EGFR mutation • BRAF mutation • EGFR T790M • ALK rearrangement • ROS1 rearrangement
|
lorigerlimab (MGD019)
almost2years
MGD019 DART® Protein in Unresectable/Metastatic Cancer (clinicaltrials.gov)
P1, N=287, Recruiting, MacroGenics | Trial completion date: Dec 2023 --> Apr 2023
Trial completion date
|
EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MSI (Microsatellite instability) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
EGFR mutation • BRAF mutation • EGFR T790M • ALK rearrangement • ROS1 rearrangement
|
lorigerlimab (MGD019)
over2years
MGD019 DART® Protein in Unresectable/Metastatic Cancer (clinicaltrials.gov)
P1, N=287, Recruiting, MacroGenics | Trial primary completion date: Jan 2022 --> Aug 2022
Clinical • Trial primary completion date
|
EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MSI (Microsatellite instability) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
EGFR mutation • BRAF mutation • EGFR T790M • ALK rearrangement • ROS1 rearrangement
|
lorigerlimab (MGD019)
3years
MGD019 DART® Protein in Unresectable/Metastatic Cancer (clinicaltrials.gov)
P1, N=287, Recruiting, MacroGenics | N=207 --> 287
Clinical • Enrollment change
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • MSI (Microsatellite instability)
|
EGFR mutation • ALK rearrangement
|
lorigerlimab (MGD019)
almost4years
[VIRTUAL] A phase I, first-in-human, open-label, dose escalation study of MGD019, an investigational bispecific PD-1 x CTLA-4 DART® molecule in patients with advanced solid tumours (ESMO 2020)
MGD019 enhances in vitro T-cell responses to levels achieved by a combination of nivolumab and ipilimumab replicas. Funding: MacroGenics, Inc. Clinical trial identification: NCT03761017.
Clinical • P1 data • PD(L)-1 Biomarker • IO biomarker
|
PD-1 (Programmed cell death 1) • MUC16 (Mucin 16, Cell Surface Associated) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • ICOS (Inducible T Cell Costimulator)
|
CTLA4 expression
|
Opdivo (nivolumab) • Yervoy (ipilimumab) • lorigerlimab (MGD019)
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