Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as MGD019
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 monoclonal antibody being studied in several advanced solid tumors, including androgen-independent prostatic cancer, pancreatic adenocarcinoma, platinum-resistant ovarian cancer, and squamous cell non small cell lung cancer. It is in Phase 2 clinical development and is not yet approved for any indication.
Lorigerlimab targets PD-1, the programmed cell death protein 1 immune checkpoint receptor. It is a monoclonal antibody designed to bind PD-1 as part of its investigational use in oncology, where checkpoint blockade is being evaluated across multiple advanced solid tumor types.
Lorigerlimab is being developed by MacroGenics, Inc., which trades on the Nasdaq under the ticker MGNX. The company is the sponsor of the clinical program evaluating lorigerlimab in advanced solid tumors, including prostate, pancreatic, ovarian, and lung cancer settings.
Lorigerlimab is in Phase 2 clinical development. It is an investigational agent and has not been approved by the FDA for any indication. Its trials span Phase 1 and Phase 2, with the most advanced studies evaluating it in metastatic castration-resistant prostate cancer and other advanced solid tumors.
Lorigerlimab trials include NCT05848011, a completed Phase 2 study with docetaxel in metastatic castration-resistant prostate cancer, NCT06730347, a recruiting Phase 2 study in platinum-resistant ovarian and related cancers, NCT07565155, a Phase 2 study in pancreatic adenocarcinoma with homologous recombination deficiency, and NCT03761017, a completed Phase 1 study in advanced solid tumors.
Yes, lorigerlimab is also known as MGD019. MGD019 is the earlier designation used in the Phase 1 study NCT03761017, titled MGD019 DART Protein in Unresectable/Metastatic Cancer. Both names refer to the same investigational PD-1-targeting monoclonal antibody developed by MacroGenics.