MacroGenics, Inc., CP-MGC026-01, Phase 1/1b, Open Label, Multi-Center, Solid Tumors, MGC026

What is the Purpose of this Study?

Primary Objective: To characterize the safety, tolerability, dose-limiting toxicities (DLTs), and maximum tolerated dose (MTD) or maximum administered dose (MAD) (if no MTD is defined) of MGC026. Secondary Objective(s): To characterize the systemic pharmacokinetics (PK) of MGC026. To characterize the immunogenicity (anti-drug antibodies [ADA]) of MGC026. To evaluate preliminary antitumor activity of MGC026.


Eligibility

  • * Adults ≥ 18 years old, able to provide informed consent
  • * Adequate performance and laboratory parameters
  • * Unresectable, locally advanced or metastatic solid tumors including: squamous cell cancer (SCC) of the head and neck, esophageal SCC, squamous and non-squamous non-small cell lung cancer, small cell lung cancer, bladder cancer, sarcoma, endometrial cancer, melanoma, castration resistant prostate cancer, breast cancer, ovarian cancer, cervical cancer, colorectal cancer gastric or gastroesophageal cancer, pancreatic carcinoma, clear cell renal cell cancer or hepatocellular cancer.
  • * Measurable disease per RECIST v1.1. Participants with metastatic CRPC without measurable disease are eligible.
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Where can I participate?

CS Cancer at The Angeles Clinic and Research Institute

More about this Clinical Trial

What is the full name of this clinical trial?

CP-MGC026-01: A Phase 1/1b, First-in-Human, Open Label, Dose Escalation and Cohort Expansion Study of MGC026 in Participants with Advanced Solid Tumors

Study Details
Disease Type/Condition

Bones and Joints, Breast, Cervix, Colon, Esophagus, Kidney, Liver, Lung, Melanoma, Other Digestive Organ, Other Female Genital, Other Urinary, Ovary, Pancreas, Prostate

Principal Investigator

Hamid, Omid

Co-Investigators

Cathie T Chung, Inderjit Mehmi, Justin Moyers, Kristopher Wentzel, Navid Hafez, Vi K. Chiu

Age Group

Adult

Phase

I

IRB Number

STUDY00003227

ClinicalTrials.gov ID

NCT06242470

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Bones and Joints, Breast, Cervix, Colon, Esophagus, Kidney, Liver, Lung, Melanoma, Other Digestive Organ, Other Female Genital, Other Urinary, Ovary, Pancreas, Prostate

Principal Investigator

Hamid, Omid

Age Group

Adult

Phase

I

IRB Number

CP-MGC026-01

ClinicalTrials.gov ID

NCT06242470

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org