Phase 1, Open Label Clinical Trial to Treat Stage IV Cancer Patients With Multiple Patient-specific Mutated Cell Surface Proteins With Chimeric Antibodies
Overview
- Phase
- Phase 1
- Intervention
- Moonshot antibodies
- Conditions
- Soft Tissue Cancer
- Sponsor
- Moonshot Antibodies
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Safety: Frequency of Grade III or greater adverse events
- Status
- Enrolling By Invitation
- Last Updated
- 7 months ago
Overview
Brief Summary
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.
Detailed Description
This is a Phase I open-label, multicenter study to evaluate the safety and feasibility of treating with chimeric antibodies that target mutated cell surface proteins. Up to 12 evaluable subjects will be treated at up to 5 study sites. Evaluable subjects are those who receive at least 4 doses of treatment. A maximum of 16 subjects will be enrolled, regardless of the number of treatment doses administered. After consent is obtained to acquire tumor and normal cells, it will be determined if sufficient archived tumor tissue is available. In the absence of sufficient archived tumor tissue, subjects will undergo biopsy of tumor. The aseptic collection of tumor material will occur in a manner suitable for DNA and RNA extraction and sequencing. Sequencing for this study will be performed in a laboratory that performs whole exome and RNA sequencing. Quality thresholds will include metrics such as base calling quality, coverage, allelic read percentages, strand bias, and alignment quality. Upon successful antibody production, the antibodies will be delivered to each subject through a series of infusions.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects 18 years of age or older who have biopsy proven cancer. The following types of malignancy will be eligible:
- •Stage IV cancer of the following types: breast cancer, colon cancer, esophageal cancer, kidney cancer, lung cancer, lymphoma, melanoma, ovarian cancer, pancreatic cancer, bladder, urothelial carcinoma, head and neck cancers, prostate cancer, sarcomas, and stomach cancer.
- •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 under Moonshot Antibodies IRB protocol #20233336 or 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
- •Hematological:
- •ANC (Absolute neutrophil count) ≥ 1000/µl (unsupported)
- •Platelets ≥ 100,000/µl (can be transfused)
- •Hemoglobin \> 8 g/dL (can be transfused)
Exclusion Criteria
- •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).
- •Subjects who have received live vaccines within 30 days prior to the first dose of trial treatment and while participating in the trial. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster, yellow fever, rabies, BCG, and typhoid vaccine.
- •Subjects who are currently receiving or have received systemic therapeutic corticosteroids ≤2 weeks prior to starting treatment.
- •Subjects receiving any investigational drug concurrently.
- •Subjects with chronic active autoimmune diseases undergoing treatment.
- •Subjects who have had prior organ transplant.
- •Subjects who have developed allergic responses to chimeric antibodies.
Arms & Interventions
Treatment group
Treatment with multiple patient-specific mutated cell surface proteins with chimeric antibodies
Intervention: Moonshot antibodies
Outcomes
Primary Outcomes
Safety: Frequency of Grade III or greater adverse events
Time Frame: From first dose of treatment through endpoint evaluation at 6 months
Frequency of Grade III or greater adverse events