Soft Tissue Sarcoma Clinical Trial Assessment 2025: Investigational Drugs, FDA Approvals, Pipeline Drugs, Therapies, Mechanism of Action, Route of Administration by DelveInsight

Soft Tissue Sarcoma Clinical Trial Assessment

(Albany, United States) According to DelveInsight, the global Soft Tissue Sarcoma pipeline includes 125+ companies actively developing over 130 treatment candidates. The analysis covers clinical trials, mechanisms of action, routes of administration, and ongoing developments in the field.

The “Soft Tissue Sarcoma Pipeline Insight, 2025” report by DelveInsight provides a detailed analysis of the current clinical landscape and future growth opportunities in the Soft Tissue Sarcoma market. It offers a thorough evaluation of pipeline products, spanning from preclinical stages to marketed therapies. The report includes comprehensive drug profiles covering mechanisms of action, clinical trial updates, regulatory approvals, and product development activities such as technology advancements, partnerships, mergers & acquisitions, funding, designations, and other key details.

Explore detailed insights into key pipeline therapies like Fibromun, Chiauranib, and LVGN6051. Stay informed on trial progress, mechanisms of action, and emerging innovations shaping the STS landscape. Access the complete Soft Tissue Sarcoma Pipeline Report

Some of the key takeaways from the Soft Tissue Sarcoma Pipeline Report:

• Soft Tissue Sarcoma pipeline includes 125+ companies actively developing over 130 treatment candidates.
• Soft Tissue Sarcoma companies working in the treatment market are Advenchen Laboratories, Philogen, Gradalis, Epizyme, Chugai Pharma France, CytRx, Taiho Pharmaceuticals, KaryoPharm Therapeutics, Nanobiotix, Apexigen, Lytix Biopharma, Incyte Corporation, Iovance Biotherapeutics, Aadi Bioscience, Inc., AVEO Pharmaceuticals, Bayer, VasGene Therapeutics, Mirati Therapeutics, Novartis Pharmaceuticals, Incyte Corporation, Tracon Pharmaceuticals, Jiangsu Hengrui Medicine, Exelixis, Qbiotics, AstraZeneca, Loxo Oncology, ImmunityBio, Monopar Therapeutics, Chipscreen Biosciences, Ltd., Agenus, C4 Therapeutics, Inc., Noxopharm Limited, Moleculin Biotech, Inc., Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd., Tracon Pharmaceuticals Inc., Guangdong Xiangxue Precision Medical Technology Co., Ltd., Cornerstone Pharmaceuticals, Takara Bio Inc., Jazz Pharmaceuticals, Lyell Immunopharma, Telix Pharmaceuticals and others, are developing therapies for the Soft Tissue Sarcoma treatment
• Emerging Soft Tissue Sarcoma therapies such as AL3818, L19 TNF, Camsirubicin, and others are expected to have a significant impact on the Soft Tissue Sarcoma market in the coming years.
• In July 2025, Calidi Biotherapeutics, Inc. (“Calidi” or the “Company”) (NYSE American: CLDI), a clinical-stage biotechnology company pioneering the development of targeted therapies with the potential to deliver genetic medicines to distal sites of disease, today announced that it received Fast Track designation from the U.S. Food and Drug Administration (FDA) for CLD-201 (SuperNova), the company’s allogeneic adipose stem-cell loaded oncolytic virus for the treatment of soft tissue sarcoma.
• In March 2025, Telix Pharmaceuticals (Innovations) Pty Ltd announced an Open-label, Phase 1 Study to Assess Safety, Tolerability, Dosimetry, Pharmacokinetics and Imaging Properties of 89Zr-olaratumab (89Zr-TLX300-CDx) in Participants With Soft Tissue Sarcoma.
• In March 2025, Thermosome GmbH announced results of a Phase I Dose Escalation Study of 3-Weekly Intravenous DPPG2-TSL-DOX Combined with Regional Hyperthermia in Locally Advanced or Metastatic Soft Tissue Sarcoma
• In March 2025, Philogen S.p.A. announced a Randomized Study to Investigate the Efficacy and Safety of the Tumor-targeting Human Antibody-cytokine Fusion Protein L19TNF in Previously Treated Patients with Advanced Stage or Metastatic Soft-tissue Sarcoma
• In March 2025, Intensity Therapeutics, Inc announced a Multicenter, Randomized, Phase 3 Study to Assess the Efficacy and Safety of INtratumorally Administered INT230-6 (SHAO, VINblastine, CIsplatin) Compared with US Standard of Care in Adults with Locally Recurrent, InoperaBLE, or Metastatic Soft Tissue Sarcomas (INVINCIBLE-3)
• In March 2025, QBiotics Group Limited announced a Phase IIa Open Label Study Evaluating the Preliminary Efficacy of Intratumoural Tigilanol Tiglate in Advanced And/or Metastatic Soft Tissue Sarcoma of the Extremities and Body Wall.
• On September 11, 2024, Actuate Therapeutics, Inc. (NASDAQ: ACTU) announced that the FDA has granted Orphan Drug Designation to elraglusib, a novel GSK-3β inhibitor. This designation is for the treatment of soft tissue sarcoma (STS), a rare and challenging cancer that involves malignant tumors in the connective tissues, such as muscles, fat, and nerves. This designation highlights the potential of elraglusib to address a significant unmet need in treating this high-impact cancer.
• In May 2024, Thermosome GmbH announced results of a Phase I Dose Escalation Study of 3-Weekly Intravenous DPPG2-TSL-DOX Combined With Regional Hyperthermia in Locally Advanced or Metastatic Soft Tissue Sarcoma
• In April 2024, Eli Lilly and Company has announced results of a Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Doxorubicin Plus Olaratumab Versus Doxorubicin Plus Placebo in Patients With Advanced or Metastatic Soft Tissue Sarcoma
• In April 2024, Philogen S.p.A. announced results of a Randomized Study to Investigate the Efficacy and Safety of the Tumor-targeting Human Antibody-cytokine Fusion Protein L19TNF in Previously Treated Patients With Advanced Stage or Metastatic Soft-tissue Sarcoma

Soft Tissue Sarcoma Overview

Soft Tissue Sarcoma (STS) is a rare group of malignant tumors that develop in connective tissues such as muscles, fat, nerves, blood vessels, and deep skin tissues. With multiple subtypes and often nonspecific symptoms, STS is challenging to diagnose and treat. Standard treatment options include surgery, radiation therapy, and chemotherapy, though relapse and metastasis remain common. Advances in targeted therapies, immunotherapies, and antibody-drug conjugates are reshaping the treatment landscape. Global research efforts and clinical trials are focused on improving survival outcomes and addressing unmet needs, making STS a key area of interest in oncology drug development.

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Soft Tissue Sarcoma Route of Administration

Soft Tissue Sarcoma pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs, such as

• Oral
• Parenteral
• Intravenous
• Subcutaneous
• Topical.

Soft Tissue Sarcoma Molecule Type

Soft Tissue Sarcoma Products have been categorized under various Molecule types, such as

• Monoclonal Antibody
• Peptides
• Polymer
• Small molecule
• Gene therapy

Soft Tissue Sarcoma Pipeline Therapeutics Assessment

• Soft Tissue Sarcoma Assessment by Product Type
• Soft Tissue Sarcoma By Stage and Product Type
• Soft Tissue Sarcoma Assessment by Route of Administration
• Soft Tissue Sarcoma By Stage and Route of Administration
• Soft Tissue Sarcoma Assessment by Molecule Type
• Soft Tissue Sarcoma by Stage and Molecule Type

DelveInsight’s Soft Tissue Sarcoma Pipeline Report covers around 130+ products under different phases of clinical development like-

• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I)
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

Further Soft Tissue Sarcoma product details are provided in the report. Download the Soft Tissue Sarcoma pipeline report to learn more about the emerging Soft Tissue Sarcoma therapies- Soft Tissue Sarcoma Clinical Trials and FDA Approvals

Soft Tissue Sarcoma Pipeline Analysis:

Fibromun + Doxorubicin (Philogen S.p.A.)

Fibromun (L19TNF) is a tumor-targeted fusion of the L19 antibody and TNF that localizes at cancer sites while sparing healthy tissue. It has shown strong anti-tumor activity alone and in combinations. The therapy is in Phase III trials for Soft Tissue Sarcoma.

Chiauranib (Chipscreen Biosciences, Ltd.)

Chiauranib is a selective Aurora B/VEGFR/PDGFR/c-Kit/CSF1R inhibitor designed to overcome resistance. It blocks angiogenesis, tumor cell mitosis, and modulates the tumor microenvironment. Currently in Phase II trials for Soft Tissue Sarcoma.

LVGN6051 + Anlotinib (Lyvgen Biopharma)

Exlinkibart (LVGN6051) is an anti-CD137/4-1BB agonist antibody that enhances T-cell and NK cell activity, boosting immune responses against tumors. It is under Phase I/II development for Soft Tissue Sarcoma.

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Scope of Soft Tissue Sarcoma Pipeline Drug Insight

• Coverage: Global
• Key Soft Tissue Sarcoma Companies: Novartis (SWX: NOVN), Epizyme (NASDAQ: EPZM), CytRx (OTCQB: CYTR), Karyopharm Therapeutics (NASDAQ: KPTI), Nanobiotix (EPA: NANO), Incyte Corporation (NASDAQ: INCY), Iovance Biotherapeutics (NASDAQ: IOVA), Aadi Bioscience, Inc. (NASDAQ: AADI), AVEO Pharmaceuticals (NASDAQ: AVEO), Bayer (ETR: BAYN), Mirati Therapeutics (NASDAQ: MRTX), Exelixis (NASDAQ: EXEL), AstraZeneca (LSE: AZN), ImmunityBio (NASDAQ: IBRX), Monopar Therapeutics (NASDAQ: MNPR), Agenus (NASDAQ: AGEN), C4 Therapeutics, Inc. (NASDAQ: CCCC), Noxopharm Limited (ASX: NOX), Moleculin Biotech, Inc. (NASDAQ: MBRX), Jazz Pharmaceuticals (NASDAQ: JAZZ), Lyell Immunopharma (NASDAQ: LYEL), Telix Pharmaceuticals (ASX: TLX) and others.
• Key Soft Tissue Sarcoma Therapies: AL3818, L19 TNF, Camsirubicin, and others.
• Soft Tissue Sarcoma Therapeutic Assessment: Soft Tissue Sarcoma current marketed and Soft Tissue Sarcoma emerging therapies
• Soft Tissue Sarcoma Market Dynamics: Soft Tissue Sarcoma market drivers and Soft Tissue Sarcoma market barriers

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Table of Contents

1. Soft Tissue Sarcoma Report Introduction

2. Soft Tissue Sarcoma Executive Summary

3. Soft Tissue Sarcoma Overview

4. Soft Tissue Sarcoma- Analytical Perspective In-depth Commercial Assessment

5. Soft Tissue Sarcoma Pipeline Therapeutics

6. Soft Tissue Sarcoma Late Stage Products (Phase II/III)

7. Soft Tissue Sarcoma Mid Stage Products (Phase II)

8. Soft Tissue Sarcoma Early Stage Products (Phase I)

9. Soft Tissue Sarcoma Preclinical Stage Products

10. Soft Tissue Sarcoma Therapeutics Assessment

11. Soft Tissue Sarcoma Inactive Products

12. Company-University Collaborations (Licensing/Partnering) Analysis

13. Soft Tissue Sarcoma Companies

14. Soft Tissue Sarcoma Key Products

15. Soft Tissue Sarcoma Unmet Needs

16 . Soft Tissue Sarcoma Market Drivers and Barriers

17. Soft Tissue Sarcoma Future Perspectives and Conclusion

18. Soft Tissue Sarcoma Analyst Views

19. Appendix

20. About DelveInsight

About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.

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