A Phase 1/1b Dose Escalation/Expansion Study of NGM438 as Monotherapy and in Combination with Pembrolizumab in Advanced or Metastatic Solid Tumors
This is an early-stage research study for an investigational drug called NGM438, either alone (monotherapy) or in combination with another drug called pembrolizumab. The goal of the study is to determine the safety and effectiveness of NGM438 in treating people with advanced or metastatic solid tumors, which are cancers that have spread to other parts of the body. The study is being conducted in two parts: Part 1a: This is a dose-escalation study, where researchers will determine the safest and most effective dose of NGM438 when given as a monotherapy. Part 1b: This part of the study will evaluate the safety and effectiveness of NGM438 in combination with pembrolizumab. Pembrolizumab is a type of immunotherapy drug that helps the immune system attack cancer cells. The study is open to adults who have advanced or metastatic solid tumors and who have not received prior treatment with an anti-PD-1 or anti-PD-L1 therapy.
Advanced: Advanced cancer means that the cancer cells from the original tumor (primary tumor) get loose, spread by traveling through the body, and start a new tumor (metastatic tumor) somewhere else in the body.
Metastatic: cancer that has spread from its original location or organ to other parts of the body.
Early-Stage: Early phase (phases I and II) studies help researchers determine: Whether a new treatment is safe, what its side effects are and the best dose of the new treatment.
For more information about the trial, click the link below:
Clinical Trial Site: Sinai
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