NCT06674538

Enrolling By InvitationPhase 1

Clinical Trial to Treat Stage IV Cancer Patients

Moonshot Antibodies Source

Moonshot Antibodies

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

Moonshot protocol #2024-01

Study Type

interventional

Estimated enrollment

12

Locations

1 country

Sites

1

Timeline

Study Start

December 30, 2024

Actual (reported)

Primary Completion

January 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Study Completion

January 2029

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: enrolling by invitation
Estimated enrollment: 12 participants
Study completion date: January 2029
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
November 4, 2024
Actual (reported)
First Posted
November 5, 2024
Actual (reported)
Study Start
December 30, 2024
Actual (reported)
Primary Completion
January 2027
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 2029
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated: September 22, 2025
Status Verified: September 2025
Last Update Submitted: September 19, 2025

Conditions

Soft Tissue Cancer

Keywords

Stage IV cancerpatient-specific mutated cell surface proteinschimeric antibodies

Outcome Measures

Primary Outcomes (1)

Safety: Frequency of Grade III or greater adverse events
Frequency of Grade III or greater adverse events
From first dose of treatment through endpoint evaluation at 6 months

Study Arms (1)

Treatment group

EXPERIMENTAL

Treatment with multiple patient-specific mutated cell surface proteins with chimeric antibodies

Drug: Moonshot antibodies

Interventions

Moonshot antibodiesDrug

Chimeric antibodies

Treatment group

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

Sponsors & Collaborators

Moonshot Antibodies
Industrylead

Study Sites (1)

Penn State Cancer Institute

Hershey, Pennsylvania, 17033, United States

MeSH Terms

Conditions

SarcomaNeoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic Type

Study Officials

David Krag, MD
Moonshot Antibodies
STUDY CHAIR

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 4, 2024

First Posted

November 5, 2024

Study Start

December 30, 2024

Actual (reported)

Primary Completion

January 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

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)

Renal: Serum creatinine ≤ 1.5 x upper limit of institutional normal.

Adequate liver function must be demonstrated, defined as:

Total bilirubin ≤ 1.5 x upper limit of normal (ULN)

ALT (SGPT) ≤ 3 times upper limit of normal (ULN)

AST (SGOT) ≤ 3 times upper limit of normal (ULN)

+3 more criteria

You may not qualify if:

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.
Subjects with symptomatic known brain metastases \< 4 weeks from radiation treatment
Subjects with significant (\>Grade 2 toxicity) renal, cardiac, pulmonary, hepatic or other organ dysfunction.
Subjects with secondary cancers that require systemic treatment.
Subjects that are pregnant or breastfeeding.
Subjects with uncontrolled serious infections or a life-threatening illness (unrelated to tumor) including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia.
+2 more criteria

Contact the study team to confirm eligibility.

Study Completion

January 2029

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated

September 22, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing: Will share
Time Frame: After data analysis and IND closure. End date is undetermined at this time.
Access Criteria: This is undetermined at this time.

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT06674538
Data provider: ClinicalTrials.gov
Source updated: 2025-09-22
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:36:06 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Treatment group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations