Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Lorigerlimab · 4 trials · 28 indications
Objective Response Rate (ORR) is defined as the proportion or percentage of patients with confirmed partial (PR) or complete (CR) best overall response.
The ORR, is defined as the percentage of patients in the response evaluable population who achieve a best overall response of complete response (CR) or partial response (PR), per RECIST, version 1.1 criteria. CR is defined as disappearance of all target and non-target lesions. PR is defined as at least a 30% decrease from baseline in the sum of diameters of target lesions.
The rPFS is defined as the time from the date of randomization to the date of first documented PD per Prostate Cancer Working Group 3 (PCWG3) criteria or death from any cause, whichever occurs first.
Safety is based on evaluation of adverse events (AEs) and serious adverse events (SAEs) from the time of study drug administration through the End of Study visit.
| Arm | Type | Description |
|---|---|---|
| Lorigerlimab Group | EXPERIMENTAL | Participants will receive Lorigerlimab with docetaxel (experimental arm) or docetaxel alone (standard-of-care arm). Participants who were randomized to the standard-of-care arm (docetaxel) and meet the criteria for radiographic disease progression may be eligible to receive Lorigerlimab as a monotherapy. Total participation duration is up to 3 years. |
| Cohort A (PROC) high dose | EXPERIMENTAL | Lorigerlimab 6 mg/kg IV every 21 days |
| Cohort A (PROC) low dose | EXPERIMENTAL | Lorigerlimab 3 mg/kg IV every 21 days |
| Cohort B (CCGC) | EXPERIMENTAL | Lorigerlimab 6 mg/kg IV every 21 days |
| Cohort C (CCGC) | EXPERIMENTAL | Lorigerlimab 3 mg/kg IV every 21 days |
| Lorigerlimab + Docetaxel and Prednisone | EXPERIMENTAL | Lorigerlimab 6 mg/kg IV (up to 2 years) and docetaxel 75 mg/m\^2 IV every 3 weeks (up to 7 months) and prednisone 5 mg orally twice daily (up to 7 months). |
| Standard of care docetaxel and prednisone | OTHER | Docetaxel 75 mg/m\^2 IV every 3 weeks and prednisone 5 mg orally twice daily.(up to 7 months) |
| Cohort 1 | EXPERIMENTAL | 0.03 mg/kg administered IV every 3 weeks. |
| Cohort 2 | EXPERIMENTAL | 0.1 mg/kg administered IV every 3 weeks. |
| Cohort 3 | EXPERIMENTAL | 0.3 mg/kg administered IV every 3 weeks. |
| Cohort 4 | EXPERIMENTAL | 1.0 mg/kg administered IV every 3 weeks. |
| Cohort 5 | EXPERIMENTAL | 30\. mg/kg administered IV every 3 weeks. |
| Cohort 6 | EXPERIMENTAL | 6.0 mg/kg administered IV every 3 weeks. |
| Cohort 7 | EXPERIMENTAL | 10.0 mg/kg administered IV every 3 weeks. |
| Name | Type | Description |
|---|---|---|
| Lorigerlimab | DRUG | 6mg/kg every 3 weeks (Q3W) Intravenous |
| docetaxel | DRUG | Docetaxel Injection is a cytotoxic anticancer drug approved to treat prostate cancer |
| Prednisone | DRUG | A corticosteroid drug approved for use with docetaxel in the treatment of prostate cancer |
Inclusion Criteria: 1. Voluntarily agree to participate by giving signed, dated, and written informed consent prior to any study-specific procedures. 2. ≥ 18 years of age. 3. Histologically confirmed pancreas carcinoma with metastatic disease. Neuroendocrine neoplasms are not eligible. Adenosquamou...
Lorigerlimab is an investigational oncology drug being studied for use in androgen-independent prostate cancer, platinum-resistant ovarian cancer, pancreatic adenocarcinoma, and squamous cell non-small cell lung cancer. It is a bispecific antibody being developed by MacroGenics, Inc. and is currently in Phase 2 clinical trials.
Lorigerlimab is a bispecific antibody that targets two immune checkpoint molecules, PD-1 and LAG-3. By binding to these inhibitory checkpoint molecules, it is designed to enhance the immune system's ability to fight cancer cells. This mechanism is being evaluated in several solid tumor types.
Lorigerlimab is being developed by MacroGenics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol MGNX. The company is conducting clinical trials to evaluate the drug's safety and efficacy in multiple cancer indications.
Lorigerlimab is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. Several Phase 2 trials are ongoing or planned to assess its effectiveness in prostate cancer, ovarian cancer, pancreatic cancer, and other advanced solid tumors.
Lorigerlimab is being studied in several clinical trials, including NCT05848011 for metastatic castration-resistant prostate cancer, NCT06730347 for platinum-resistant ovarian cancer, and NCT07565155 for pancreatic adenocarcinoma with homologous recombination deficiency. An earlier Phase 1 trial, NCT03761017, has been completed.
Yes, Lorigerlimab is also known as MGD019. The drug was previously referred to as MGD019 in early clinical trials, such as the Phase 1 study NCT03761017, which evaluated the DART protein in patients with unresectable or metastatic cancer.