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RecruitingLast updated: 30 September 2024

LUNA: This trial is assessing how safe and well-tolerated a new drug (called MGC026) is in people with solid cancers that are locally advanced, inoperable, metastatic, relapsed or refractory.A Phase 1/1b First-in-Human, Open Label, Dose Escalation and Cohort Expansion Study of MGC026 in Participants With Advanced Solid Tumors

Trial purpose

Medical clipboardCancer treatment

Tumor type

Multi-Cancer Multi-Cancer

Age

People18+

Trial acronym

LUNA

Clinical summary

Summary

Eligible 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 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. 

The study is split into two parts: one where the dosage is gradually increased (Experimental), and another where specific groups of participants are studied in more detail (Expansion).

Eligible cancer types include:

  • Squamous cell carcinoma of the head and neck
  • Oesophageal squamous cell carcinoma
  • Squamous and non-squamous non-small cell lung cancer
  • Small cell lung cancer
  • Bladder cancer
  • Endometrial cancer
  • Melanoma
  • Castration-resistant prostate cancer
  • Breast cancer
  • Ovarian cancer
  • Cervical cancer
  • colorectal cancer
  • gastric / gastro-oesophageal junction cancer
  • pancreatic cancer
  • clear cell renal cell cancer
  • liver (hepatocellular) cancer.

Please note: Austin Health is not currently recruiting people with sarocma.

Conditions

This trial is treating people with solid cancers

Eligibility

Inclusion

  • 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

  • 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.

Inclusion

  • You have had treatment, but your cancer has come back (relapsed or recurrent).
  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • Your cancer has not spread to other parts of the body (localised).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

MacroGenics

Scientific Title

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

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