A Study of MGC026 in Participants With Advanced Solid Tumors

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06242470
• Other study ID #: CP-MGC026-01
• Status: Recruiting
• Phase: Phase 1
• Start date: March 6, 2024
• Est. completion date: October 2028

Study information

• Verified date: June 2024
• Source: MacroGenics
• Contact: Global Trial Manager
• Phone: 301-251-5172
• Email: info[@]macrogenics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is designed to understand the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of MGC026 in participants with relapsed or refractory, unresectable, locally advanced or metastatic solid tumors The study has a dose escalation portion and a cohort expansion portion of the study.

Participants will receive MGC026 by intravenous (IV) infusion. The dose of MGC026 will be assigned at the time of enrollment. Participants may receive up to 35 treatments if there are no severe side effects and as long as the cancer does not get worse. Participants will be monitored for side effects, and progression of cancer, have blood samples collected for routing laboratory work, and blood samples collected for research purposes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 230
• Est. completion date: October 2028
• Est. primary completion date: May 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

• Must be willing to use highly effective methods of birth control from the time of consent through 7 months after discontinuation of MGC026.

• Not pregnant or breastfeeding.

Exclusion Criteria:

• Any underlying medical or psychiatric condition impairing participant's ability to receive, tolerate, or comply with the planned treatment or study procedures.

• Another cancer that required treatment within the past 2 years, with the exception of those with low risk of cancer spreading or death such as adequately treated non melanomatous skin cancer, localized prostate cancer (Gleason Score < 6), or carcinoma in situ.

• Patients with history of prior central nervous system (CNS) metastasis must have been treated, be asymptomatic, and not have concurrent treatment for CNS disease, progression of CNS metastases on magnetic resonance imaging, computed tomography or positron emission tomography, or history of leptomeningeal disease or cord compression at the time of enrollment.

• Treatment with surgery, systemic cancer therapy, immunotherapy, chimeric antigen receptor-T therapy, or anti-hormonal within protocol specified intervals.

• Prior autologous or allogeneic stem cell or solid organ transplant.

• Clinically significant cardiovascular, pulmonary, or gastrointestinal disorders.

• Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 1 week of first study drug administration.

• Known history of hepatitis B or C infection or known positive test for hepatitis B surface antigen or core antigen, or hepatitis C polymerase chain reaction.

• Known positive testing for human immunodeficiency virus or history of acquired immune deficiency syndrome.

• History of primary immunodeficiency.

• Major trauma or major surgery within 4 weeks of first study drug administration.

• Known hypersensitivity to recombinant proteins.

Related Conditions & MeSH terms

• Advanced Cancer
• Advanced Solid Tumor
• Bladder Cancer
• Carcinoma
• Carcinoma, Renal Cell
• Castration Resistant Prostatic Cancer
• Cervical Cancer
• Clear Cell Renal Cell Carcinoma
• Colorectal Cancer
• Endometrial Cancer
• Endometrial Neoplasms
• Gastric Cancer
• Gastro-esophageal Cancer
• Hepatocellular Carcinoma
• Lung Neoplasms
• Melanoma
• Metastatic Cancer
• Non Small Cell Lung Cancer
• Pancreas Cancer
• Pancreatic Neoplasms
• Platinum-resistant Ovarian Cancer
• Prostatic Neoplasms
• Prostatic Neoplasms, Castration-Resistant
• Sarcoma
• Small Cell Lung Carcinoma
• Small-cell Lung Cancer
• Squamous Cell Carcinoma of Head and Neck

Intervention

Biological:
• MGC026 Dose Escalation
Escalating doses of MGC026
• MGC026 Dose for Expansion
MGC026 recommended dose for expansion

Locations

Country	Name	City	State
Australia	Austin Health- Olivia Newton John Cancer Center	Heidelberg	Victoria
United States	START Midwest	Grand Rapids	Michigan
United States	The University of Texas MD Anderson Cancer Center	Houston	Texas
United States	START Mountain Region	West Valley City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
MacroGenics

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events (AEs) and serious AEs (SAEs)		Throughout the study, up to 135 weeks
Secondary	Overall response rate in advanced solid tumors	The objective response rate (ORR) per RECIST v1.1 is estimated as the proportion of participants in the Response Evaluable population who achieve best overall response of complete response (CR) or partial response (PR) (called responders). Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) is used to classify responses.	Throughout the study, up to 135 weeks
Secondary	Duration of response (DoR) in advanced solid tumors	DoR is defined as the time from the date of initial response (CR or PR) to the date of first documented progression or death from any cause, whichever occurs first. (RECIST 1.1) is used to classify responses.	Throughout the study, up to 135 weeks
Secondary	ORR rate in metastatic castration resistant prostate cancer (mCRPC)	The ORR per Prostate Cancer Working Group 3 (PCWG3) criteria is estimated as the proportion of participants in the Response Evaluable population who achieve best overall response of CR or PR (called responders).	Throughout the study, up to 135 weeks
Secondary	DoR in mCRPC	DoR is defined as the time from the date of initial response (CR or PR) to the date of first documented progression, per PCWG3 criteria or death from any cause, whichever occurs first.	Throughout the study, up to 135 weeks
Secondary	Mean (standard deviation [SD]) of MGC026 maximum serum concentration (Cmax)	The maximum concentration in the bloodstream at the end of the infusion.	Day 1 of every 21-day cycle, throughout the study, average of 1 year.
Secondary	Mean (SD) of MGC026 area under the time concentration curve (AUC)	Calculated exposure to MGC026	Day 1 of every 21-day cycle, throughout the study, average of 1 year.
Secondary	Number of participants who develop anti-MGC026 antibodies (immunogenicity)	Development of anti-MGC026 antibodies in the bloodstream	Day 1 of every 21-day cycle, throughout the study, average of 1 year.