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A Study of MGC026 in Participants With Advanced Solid Tumors

ConditionsAdvanced Solid TumorAdvanced CancerMetastatic CancerSquamous Cell Carcinoma of Head and NeckNon Small Cell Lung CancerSmall-cell Lung CancerBladder CancerSarcomaEndometrial CancerMelanomaCastration Resistant Prostatic CancerCervical CancerColorectal CancerGastric CancerGastro-esophageal CancerPancreas CancerClear Cell Renal Cell CarcinomaHepatocellular CarcinomaPlatinum-resistant Ovarian CancerBreast CancerOvarian CancerEsophageal Squamous Cell Cancer (SCC)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMacroGenics

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults ≥ 18 years old, able to provide informed consent

Adequate performance and laboratory parameters

Availability of archival or formalin-fixed paraffin-embedded tumor tissue sample. Participants may undergo a fresh tumor biopsy to obtain a specimen for testing if an archival tumor sample is not available. Participants with no available archival tissue sample who cannot safely undergo a fresh biopsy as determined by consultation between the sponsor and investigator are eligible

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • MGC026 Dose Escalation

    Biological/Vaccine

    Escalating doses of MGC026

  • MGC026 Dose for Expansion

    Biological/Vaccine

    MGC026 recommended dose for expansion

Treatment groups

250 Participants
are divided into 12 treatment groups

12

Treatment groups

See each treatment group below.

Group A: Cohort 1Experimental treatment 1 intervention
Group B: Cohort 2Experimental treatment 1 intervention
Group C: Cohort 3Experimental treatment 1 intervention
Group D: Cohort 4Experimental treatment 1 intervention
Group E: Cohort 5Experimental treatment 1 intervention
Group F: Cohort 6Experimental treatment 1 intervention
Group G: Expansion cohort 1Experimental treatment 1 intervention
Group H: Expansion cohort 2Experimental treatment 1 intervention
Group I: Expansion cohort 3Experimental treatment 1 intervention
Group J: Expansion cohort 4Experimental treatment 1 intervention
Group K: Expansion Cohort 5Experimental treatment 1 intervention
Group L: Expansion Cohort 6Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with adverse events (AEs) and serious AEs (SAEs), AEs leading to dose delay, AEs leading to dose reduction, AEs leading to treatment discontinuations, AEs meeting criteria for dose limiting toxicity, and AEs of special interest.

Time frame
Throughout the study, up to 135 weeks

Secondary outcomes

1

Overall response rate in advanced solid tumors

The objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) is used to estimate the proportion of participants in the Response Evaluable population who achieve best overall response of complete response (CR) or partial response (PR) (called responders). Complete response (CR) is defined as disappearance of all target and non-target lesions. Partial response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, no progression of non-target lesions, and no new lesions

Time frame
Throughout the study, up to 135 weeks
2

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.

Time frame
Throughout the study, up to 135 weeks
3

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).

Time frame
Throughout the study, up to 135 weeks
4

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.

Time frame
Throughout the study, up to 135 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

MacroGenics

Lead sponsor

Source ClinicalTrials.gov
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