Treatment of Stage IV Cancer Patients With Multiple Patient-specific Mutated Cell Surface Proteins With Chimeric Antibodies

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre hospitalier de l'Université de Montréal (CHUM)

About this trial

The purpose of this research is to study the safety and effectiveness of investigational antibodies attacking certain areas on the surface of cancer cells so that the body can kill the cancer cells. The antibodies will be made in a laboratory from cells taken from each subject's tumor so they will be made specifically per subject.

The first step is to take blood and tumor samples so that the laboratory can produce antibodies specific to each subject's tumor. During this process, the study team will identify specific areas on the cancer cells that are not normally present in healthy cells so that the antibodies can find the cancer cells that should be destroyed.

The second step is to deliver the antibodies to each subject through a series of infusions.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects who have refractory or progressive disease after at least 1 line of systemic treatment or who have declined additional curative standard of care therapy(ies).

Subjects willing to consent to obtaining a blood sample and archived tumor tissue for genomic extraction and amplification. If archived tumor tissue is not available, a new biopsy sample will be required. If sequencing was previously completed on the patient's tumor as part of clinical care, these results and samples may be used and duplicative tumor sequencing will not be necessary.

Subjects must have measurable disease as defined per the Response Evaluation Criteria in Solid Tumor (RECIST) at the time of biopsy. Archived tumor must be available or tumor must be accessible for biopsy.

Karnofsky Score must be ≥ 60

Disqualifiers

Insufficient tumor tissue for genome sequencing.

Known human immunodeficiency virus infection.

Subjects who have received any cytotoxic treatment within 3 weeks of antibody treatment.

Subjects who have received any radiotherapy to the tumor biopsy sample site within the last 14 days (radiation may be included in treatment decision after biopsy).

Trial design

Design model

Single group

Treatments tested in this trial

  • Moonshot Antibodies

    Drug

    Chimeric antibodies

Treatment groups

16 Participants
are divided into 1 treatment group
Group A: Treatment groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety

Frequency of Grade III or greater adverse events according to CTCAE v5

Time frame
From first dose of treatment through endpoint evaluation at 6 months

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: