Chimeric Antibodies for Soft Tissue Sarcoma

Overseen By Clinical Trial Manager

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Moonshot Antibodies

Must not be taking: Cytotoxic drugs, Corticosteroids, Live vaccines

Disqualifiers: HIV, Autoimmune diseases, Organ transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new treatment using lab-made antibodies (chimeric antibodies) to help the body fight soft tissue sarcoma, a type of cancer. The researchers will create antibodies specifically designed to target and attack the cancer cells in each participant's tumor, aiming to improve safety and effectiveness. Participants will receive these antibodies through infusions. Individuals with Stage IV cancer, including certain types like breast, lung, or pancreatic cancer, who have not responded to other treatments, might be a good fit for this trial. Participants need to provide blood and tumor samples for the study. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have received any cytotoxic treatment within 3 weeks of antibody treatment or systemic therapeutic corticosteroids within 2 weeks prior to starting treatment.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that special antibodies, called chimeric antibodies, are under study for their safety and ability to target cancer cells in soft tissue sarcoma. One study examined a specific type of these antibodies, known as OTSA101, and found it generally safe for patients, with no major safety concerns. This finding reassures those considering joining a trial.

The current trial is in its early stages, focusing mainly on safety. These early trials typically involve a small number of participants and closely monitor any side effects. The trial's progression suggests some confidence in the safety of these antibodies based on earlier research.

Overall, while more information is needed, initial results suggest that chimeric antibodies could be a safe option for treating soft tissue sarcoma. Participants receive close monitoring to ensure their safety throughout the trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for soft tissue sarcoma?

Researchers are excited about chimeric antibodies for soft tissue sarcoma because they target cancer cells in a highly specific way. Unlike standard treatments like chemotherapy and radiation, which affect both healthy and cancerous cells, chimeric antibodies are designed to bind to patient-specific mutated proteins on the cancer cell surface, minimizing damage to normal cells. This precision targeting could lead to fewer side effects and potentially more effective treatment outcomes, making it a promising advancement in the fight against this aggressive cancer type.

What evidence suggests that chimeric antibodies might be an effective treatment for soft tissue sarcoma?

Studies have shown encouraging results for chimeric antibodies in treating soft tissue sarcoma. One study found that two patients experienced partial tumor shrinkage, while ten others maintained stable disease, meaning their cancer did not worsen. In this trial, participants will receive treatment with multiple patient-specific mutated cell surface proteins using chimeric antibodies. These antibodies target and attack specific parts of cancer cells absent in healthy cells. This targeted approach aims to help the body destroy cancer cells more effectively. Although research remains in the early stages, results suggest that chimeric antibodies could be a promising option for people with this type of cancer. ^{2 3 4 6 7}

Who Is on the Research Team?

David Krag, MD

Principal Investigator

Moonshot Antibodies

Are You a Good Fit for This Trial?

This trial is for individuals with advanced (Stage IV) sarcoma or soft tissue sarcoma. Participants must have a tumor that can be used to create personalized chimeric antibodies. Specific eligibility criteria are not provided, but typically include factors like overall health status and prior treatments.

Inclusion Criteria

Post-pubertal study subjects need to agree to use effective birth control methods

Informed written consent required from all subjects

I agree to provide a blood sample and my stored tumor tissue for research.

Exclusion Criteria

Insufficient tumor tissue for whole exome sequencing

Concurrent use of investigational drugs

I am HIV positive.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Antibody Production

Blood and tumor samples are collected to produce antibodies specific to each subject's tumor

4-6 weeks

Treatment

Participants receive chimeric antibodies through a series of infusions

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Chimeric Antibodies

Trial Overview The trial is testing the safety and effectiveness of custom-made chimeric antibodies designed to target cancer cells in each patient. These antibodies aim to mark the cancer cells so the body's immune system can find and destroy them. The treatment involves taking samples from patients' tumors, creating specific antibodies in a lab, and then administering these through infusions.

How Is the Trial Designed?

Group I: Treatment group Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Moonshot Antibodies

Lead Sponsor

Trials

1

Recruited

10+

Published Research Related to This Trial

Chimeric T cells targeting the B-cell antigen CD19 show reduced activity when exposed to T regulatory cells, which can inhibit their ability to proliferate and kill cancer cells.

A modified chimeric receptor that includes the CD28 molecule enhances T cell proliferation and activity even in the presence of T regulatory cells, suggesting a promising approach for improving chimeric T-cell therapy in B-cell malignancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addition of the CD28 signaling domain to chimeric T-cell receptors enhances chimeric T-cell resistance to T regulatory cells. Loskog, A., Giandomenico, V., Rossig, C., et al.[2022]

Citations

1. withpower.com withpower.com/trial/phase-1-soft-tissue-cancer-2025-d6c45

Chimeric Antibodies for Soft Tissue Sarcoma These antibodies combine parts from different species to enhance their ability to fight tumors, suggesting potential benefits for treating soft tissue sarcoma.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11368005/

New strategies in soft tissue sarcoma treatment - PMC The efficacy assessment revealed that two patients (9.5%) achieved a partial response (PR), ten patients (47.6%) maintained stable disease (SD) ...

3. ascopubs.org ascopubs.org/doi/10.1200/EDBK_432234

Immunotherapy in Sarcoma: Current Data and Promising ... We review the current evidence for immunotherapy use in bone sarcomas (BS) and soft tissue sarcomas (STS), with immune checkpoint inhibitors (ICI) and adoptive ...

4. esmoopen.com esmoopen.com/article/S2059-7029(25)01706-5/fulltext

Expression of antibody–drug conjugate targets in soft ... Cathepsin protease expression in infiltrative soft tissue sarcomas: cathepsin-K correlates with infiltrative tumor growth and clinical outcomes.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0147027221001112

Discovery of targeted expression data for novel antibody ... We used RNA sequencing data from Cancer Genome Atlas (TCGA) to analyze expression of target antigens in sarcoma subtypes.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7598286/

Predicting the Efficacy and Safety of TACTICs (Tumor ... Sarcomas have few effective treatment options due to the rarity and diversity and have a high risk of recurrence and metastasis.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT01469975

NCT01469975 | First in Man Study Investigating the ... OncoTherapy Science Inc. has developed a chimeric humanized monoclonal antibody (mAb) against FZD10, named OTSA101. Non-radiolabeled OTSA101 antibody has only ...