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MacroGenics (MGNX)
NASDAQ:MGNX
Lorigerlimab
Platinum-Resistant Fallopian Tube Carcinoma, Platinum-Resistant Primary Peritoneal Carcinoma, Endometrial Cancer, Platinum-Resistant Ovarian Cancer, Clear Cell Adenocarcinoma Of Ovary, Clear Cell Adenocarcinoma Of Vulva, Clear Cell Adenocarcinoma Of Vagina, Clear Cell Adenocarcinoma Of Cervix, Clear Cell Adenocarcinoma Of Uterus, Clear Cell Adenocarcinoma Of Fallopian Tube, Clear Cell Adenocarcinoma Of Peritoneum
Phase II
Recruiting
A Study of Lorigerlimab in Participants With Advanced Solid Tumors
Dec 09, 2024
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Mgc028
Advanced Solid Tumors, Colorectal Carcinoma, Pancreatic Carcinoma, Cholangiocarcinoma, Nsclc Adenocarcinoma
Phase I
Recruiting
A Study of MGC028 in Participants With Advanced Solid Tumors
Dec 04, 2024
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Mgc026 Dose Escalation, Mgc026 Dose For Expansion
Cervical Cancer, Ovarian Cancer, Bladder Cancer, Melanoma, Colorectal Cancer, Breast Cancer, Advanced Solid Tumor, Non Small Cell Lung Cancer, Sarcoma, Pancreas Cancer, Small-cell Lung Cancer, Gastric Cancer, Hepatocellular Carcinoma, Clear Cell Renal Cell Carcinoma, Advanced Cancer, Metastatic Cancer, Endometrial Cancer, Squamous Cell Carcinoma Of Head And Neck, Platinum-Resistant Ovarian Cancer, Castration Resistant Prostatic Cancer, Gastro-Esophageal Cancer, Esophageal Squamous Cell Cancer (Scc)
Phase I
Recruiting
A Study of MGC026 in Participants With Advanced Solid Tumors
Jan 12, 2024
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Docetaxel, Prednisone, Lorigerlimab
Androgen-Independent Prostatic Cancer, Androgen-Resistant Prostatic Cancer, Hormone Refractory Prostatic Cancer, Immunotherapy, Prostate Cancer Recurrent, Androgen-Independent Prostatic Neoplasms, Androgen-Insensitive Prostatic Cance, Immune Checkpoint Inhibitor, Inhibitory Checkpoint Molecule
Phase II
Active Not Recruiting
A Study of Lorigerlimab With Docetaxel or Docetaxel Alone in Participants With Metastatic Castration-Resistant Prostate Cancer
Apr 17, 2023
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Enzalutamide, Abiraterone, Vobramitamab Duocarmazine 2.0 Mg (Arm A), Vobramitamab Duocarmazine 2.7 Mg (Arm B), Vobramitamab Duocarmazine
Melanoma, Non-small Cell Lung Cancer, Small-cell Lung Cancer, Head And Neck Squamous Cell Carcinoma, Malignant Melanoma, Castration-Resistant Prostatic Cancer, Carcinoma, Squamous Cell Of Head And Neck, Anal Cancer, Anal Neoplasm, Androgen-Independent Prostatic Cancer, Androgen-Insensitive Prostatic Cancer, Androgen-Resistant Prostatic Cancer, Hormone Refractory Prostatic Cancer, Laryngeal Squamous Cell Carcinoma, Oral Squamous Cell Carcinoma, Non-Small Cell Carcinoma, Small Cell Carcinoma
Phase II
Completed
A Study of Vobramitamab Duocarmazine in Participants With Metastatic Castration Resistant Prostate Cancer and Other Solid Tumors
Sep 19, 2022
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Mgd024
Myelodysplastic Syndromes, Blastic Plasmacytoid Dendritic Cell Neoplasm, Classical Hodgkin Lymphoma, Chronic Myeloid Leukemia, Leukemia, Acute Myeloid, Leukemia, B-Cell, Leukemia, Hairy Cell, Mastocytosis, Aggressive Systemic
Phase I
Recruiting
A Study of MGD024 in Patients With Relapsed or Refractory Hematologic Malignancies
May 02, 2022
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Mgd020, Mgd014
Human Immunodeficiency Virus I Infection, Immunodeficiency Virus Type 1, Human, Human Immunodeficiency Virus Type 1
Phase I
Completed
A Study of MGD020 Alone or Combined With MGD014 in Persons With HIV-1 on Antiretroviral Therapy
Feb 18, 2022
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Vobramitamab Duocarmazine, Lorigerlimab
Epithelial Ovarian Cancer, Advanced Solid Tumor, Renal Cell Carcinoma, Malignant Melanoma, Castration-Resistant Prostatic Cancer, Hepatocellular Cancer, Pancreatic Ductal Carcinoma
Phase I
Completed
A Study of MGC018 in Combination With MGD019 in Participants With Advanced Solid Tumors
Feb 12, 2022
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Imgc936
Advanced Solid Tumor
Phase I/II
Completed
First-in-Human Study of IMGC936 in Participants With Advanced Solid Tumors
Oct 27, 2020
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Trastuzumab, Chemotherapy, Retifanlimab, Margetuximab, Tebotelimab
Gastric Cancer, Gastroesophageal Junction Cancer, Her2-Positive Gastric Cancer
Phase II/III
Completed
Combination Margetuximab, Retifanlimab, Tebotelimab, and Chemotherapy Phase 2/3 Trial in HER2+ Gastric/GEJ Cancer
Sep 05, 2019
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does MacroGenics (MGNX) have in its pipeline
MGNX is currently developing the following drugs: Lorigerlimab, Mgc028, Mgc026 Dose Escalation, Mgc026 Dose For Expansion. These drug candidates are in various stages of clinical development as the company works toward FDA approval.