CLINICAL TRIALS PROFILE FOR THIOPLEX

All Clinical Trials for Thioplex

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00003926 ↗	Amifostine to Protect From Side Effects of PSCT in Treating Patients With Solid Tumors	Terminated	Masonic Cancer Center, University of Minnesota	Phase 1	1998-11-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of high-dose chemotherapy. PURPOSE: Phase I trial to study the effectiveness of amifostine in protecting from the side effects of peripheral stem cell transplantation in treating patients who have high-risk or relapsed solid tumors.
NCT01505569 ↗	Auto Transplant for High Risk or Relapsed Solid or CNS Tumors	Recruiting	Masonic Cancer Center, University of Minnesota	N/A	2011-10-20	This is a standard of care treatment guideline for high risk or relapsed solid tumors or CNS tumors consisting of a busulfan, melphalan, thiotepa conditioning (for solid tumors) or carboplatin and thiotepa conditioning (for CNS tumors) followed by an autologous peripheral blood stem cell transplant. For solid tumors, if appropriate, disease specific radiation therapy at day +60. For CNS tumors, the conditioning regimen and autologous peripheral blood stem cell transplant will be given for 3 cycles.
NCT02061800 ↗	CD34+ (Malignant) Stem Cell Selection for Patients Receiving Allogenic Stem Cell Transplant	Recruiting	Diane George	Phase 1/Phase 2	2013-06-03	The purpose of this study is to learn more about the effects of (classification determinant) CD34+ stem cell selection on graft versus host disease (GVHD) in children, adolescents, and young adults. CD34+ stem cells are the cells that make all the types of blood cells in the body. GVHD is a condition that results from a reaction of transplanted donor T-lymphocytes (a kind of white blood cell) against the recipient's body and organs. Study subjects will be offered treatment involving the use of the CliniMACS® Reagent System (Miltenyi Biotec), a CD34+ selection device to remove T-cells from a peripheral blood stem cell transplant in order to decrease the risk of acute and chronic GVHD. This study involves subjects who are diagnosed with a malignant disease, that has either failed standard therapy or is unlikely to be cured with standard non-transplant therapy, who will receive a peripheral blood stem cell transplant. A malignant disease includes the following: Chronic Myeloid Leukemia (CML) in chronic phase, accelerated phase or blast crisis; Acute Myelogenous Leukemia (AML); Myelodysplastic Syndrome (MDS); Juvenile Myelomonocytic Leukemia (JMML); Acute Lymphoblastic Leukemia (ALL); or Lymphoma (Hodgkin's and Non-Hodgkin's).
NCT02061800 ↗	CD34+ (Malignant) Stem Cell Selection for Patients Receiving Allogenic Stem Cell Transplant	Recruiting	Diane George, MD	Phase 1/Phase 2	2013-06-03	The purpose of this study is to learn more about the effects of (classification determinant) CD34+ stem cell selection on graft versus host disease (GVHD) in children, adolescents, and young adults. CD34+ stem cells are the cells that make all the types of blood cells in the body. GVHD is a condition that results from a reaction of transplanted donor T-lymphocytes (a kind of white blood cell) against the recipient's body and organs. Study subjects will be offered treatment involving the use of the CliniMACS® Reagent System (Miltenyi Biotec), a CD34+ selection device to remove T-cells from a peripheral blood stem cell transplant in order to decrease the risk of acute and chronic GVHD. This study involves subjects who are diagnosed with a malignant disease, that has either failed standard therapy or is unlikely to be cured with standard non-transplant therapy, who will receive a peripheral blood stem cell transplant. A malignant disease includes the following: Chronic Myeloid Leukemia (CML) in chronic phase, accelerated phase or blast crisis; Acute Myelogenous Leukemia (AML); Myelodysplastic Syndrome (MDS); Juvenile Myelomonocytic Leukemia (JMML); Acute Lymphoblastic Leukemia (ALL); or Lymphoma (Hodgkin's and Non-Hodgkin's).

Clinical Trial Conditions for Thioplex

Condition Name

Condition Name for Thioplex
Intervention	Trials
Retinoblastoma	2
Juvenile Myelomonocytic Leukemia (JMML)	2
Chronic Myeloid Leukemia (CML)	2
Acute Lymphoblastic Leukemia (ALL)	2

Condition MeSH

Condition MeSH for Thioplex
Intervention	Trials
Lymphoma	3
Leukemia, Myeloid, Acute	3
Leukemia, Myeloid	3
Leukemia, Myelogenous, Chronic, BCR-ABL Positive	3

Clinical Trial Locations for Thioplex

Trials by Country

Trials by Country for Thioplex
Location	Trials
United States	13
Canada	1
Austria	1
Italy	1
Czechia	1

Trials by US State

Trials by US State for Thioplex
Location	Trials
Massachusetts	2
New York	2
Minnesota	2
Florida	1
Tennessee	1

Clinical Trial Progress for Thioplex

Clinical Trial Phase

Clinical Trial Phase for Thioplex
Clinical Trial Phase	Trials
Phase 2/Phase 3	1
Phase 2	2
Phase 1/Phase 2	2

Clinical Trial Status

Clinical Trial Status for Thioplex
Clinical Trial Phase	Trials
Recruiting	3
Not yet recruiting	1
Active, not recruiting	1

Clinical Trial Sponsors for Thioplex

Sponsor Name

Sponsor Name for Thioplex
Sponsor	Trials
Masonic Cancer Center, University of Minnesota	2
Dana-Farber Cancer Institute	1
Massachusetts General Hospital	1

Sponsor Type

Sponsor Type for Thioplex
Sponsor	Trials
Other	10
Industry	1

Clinical Trials, Market Analysis, and Projections for Thioplex and Related Compounds

Introduction to Thioplex and Related Compounds

Thioplex, also known as thiotepa, is a chemotherapeutic agent used in the treatment of various cancers, including bladder, ovarian, and breast cancer. It is also utilized in conditioning regimens prior to bone marrow transplants. Here, we will delve into the current clinical trials, market analysis, and projections for Thioplex and related compounds.

Clinical Trials Update

THIO-101 Trial for NSCLC

A significant clinical trial update comes from the THIO-101 study, which investigated the combination of 6-thio-2’-deoxyguanosine (THIO) with cemiplimab (Libtayo) in patients with advanced non-small cell lung cancer (NSCLC) who had previously received immune checkpoint inhibitors.

• Patient Outcomes: The trial showed enduring activity among patients, with an objective response rate (ORR) of 38% in the selected 180-mg dose group. This is notably higher than the approximately 6% ORR seen with standard therapies in a heavily pretreated population[1].
• Safety and Tolerability: The combination was generally well-tolerated, with most adverse effects being grade 1 or 2. No dose-limiting toxicities were reported during the safety lead-in phase[1].
• Biomarkers: The study also highlighted the induction of telomer dysfunction-induced foci (TIF) in circulating tumor cells, suggesting a potential link between TIF positivity and more favorable outcomes[1].

Other Clinical Trials

The Cancer Prevention Clinical Trials Network (CP-CTNet) conducts early-phase clinical trials, including phase 0, phase I, and phase II trials, to assess the safety, tolerability, and cancer preventive potential of interventions. While not specifically focused on Thioplex, such networks are crucial for the development of new cancer therapies and could potentially include Thioplex or similar compounds in future trials[4].

Market Analysis

Global Thiotepa Market

The global Thiotepa market is experiencing significant growth driven by several factors:

• Market Size: The market was valued at USD 1.2 billion in 2023 and is expected to reach USD 2.6 billion by 2031, growing at a CAGR of 9.2% from 2024 to 2031[2].
• Applications: Thiotepa is increasingly used in cancer chemotherapy, oncology treatments, and as part of pharmaceutical industry applications. Its use in treating bladder, ovarian, and breast cancer, as well as in conditioning regimens for bone marrow transplants, is driving market growth[2].
• Geographical Segments: The market is segmented by geography, with North America, Europe, Asia-Pacific, South America, and the Middle East and Africa being key regions. The growing demand for potent chemotherapeutic drugs, advancements in oncology research, and increasing healthcare spending are key drivers[2].

NSCLC Market Context

The non-small cell lung cancer (NSCLC) market provides a broader context for the potential impact of Thioplex and related compounds:

• Market Growth: The global NSCLC market is projected to reach $26.8 billion by 2025, with a CAGR of 15.7%. The China NSCLC market is expected to grow rapidly, reaching $4.3 billion by 2025[5].
• Therapeutic Shifts: The NSCLC market is shifting towards immunotherapies (IO), which are expected to account for 65% of the market by 2025, while chemotherapy and targeted therapies will account for the remaining 35%[5].

Projections and Future Outlook

Growth Drivers

Several factors are expected to drive the growth of the Thiotepa market and related cancer therapies:

• Increasing Cancer Incidence: The global increase in cancer incidence is a major driver, as it increases the demand for potent chemotherapeutic agents like Thiotepa[2].
• Advancements in Oncology: Developments in oncology research and the creation of tailored cancer medicines are expanding the applications of Thiotepa and similar compounds[2].
• Healthcare Spending: Rising healthcare spending and easier access to cancer therapies in developing nations are also contributing to market growth[2].

Challenges and Opportunities

• Biosimilar Erosion: The introduction of biosimilars could impact the market share of branded drugs, including those used in combination with Thiotepa. However, this also presents opportunities for cost-effective treatments[5].
• Personalized Medicine: The use of biomarkers like TIF positivity in the THIO-101 trial suggests a future where cancer therapies can be personalized, leading to better outcomes and potentially higher market demand for targeted therapies[1].

Key Takeaways

• Clinical Trials: The THIO-101 trial demonstrates the efficacy and tolerability of THIO in combination with cemiplimab for advanced NSCLC.
• Market Growth: The global Thiotepa market is expected to grow significantly, driven by increasing cancer incidence, advancements in oncology, and rising healthcare spending.
• NSCLC Market: The NSCLC market is shifting towards immunotherapies, but there remains a significant role for chemotherapy and targeted therapies.
• Future Outlook: Personalized medicine and the use of biomarkers are expected to enhance treatment outcomes and drive market growth.

FAQs

What is the current status of the THIO-101 clinical trial?

The THIO-101 trial has shown enduring activity in patients with advanced NSCLC who received THIO plus cemiplimab, with an ORR of 38% in the selected 180-mg dose group[1].

How is the global Thiotepa market expected to grow?

The global Thiotepa market is expected to grow from USD 1.2 billion in 2023 to USD 2.6 billion by 2031, at a CAGR of 9.2% from 2024 to 2031[2].

What are the key drivers of the Thiotepa market growth?

Key drivers include the increasing incidence of cancer, advancements in oncology research, and rising healthcare spending[2].

How does the NSCLC market impact the use of Thiotepa?

The NSCLC market is shifting towards immunotherapies, but chemotherapy and targeted therapies, including those involving Thiotepa, will still play a significant role[5].

What role do biomarkers play in the future of cancer therapies like Thiotepa?

Biomarkers like TIF positivity can help personalize cancer therapies, leading to better outcomes and potentially higher market demand for targeted therapies[1].

What are the potential challenges for the Thiotepa market?

Challenges include the introduction of biosimilars, which could impact market share, and the need for continuous innovation to stay competitive in the oncology market[5].

Sources

1. Cancer Network: "THIO Combo Shows Enduring Activity in Advanced Non–Small Cell Lung Cancer"
2. Market Research Intellect: "Thiotepa Market Size and Projections"
3. Grand View Research: "Clinical Trials Market Size, Share And Growth Report, 2030"
4. National Cancer Institute: "Cancer Prevention Clinical Trials Network (CP-CTNet)"
5. GlobalData: "NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025"