TH1902 for Cancer

Not currently recruiting at 8 trial locations

Overseen By Kathya Daigle

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Theratechnologies

Must not be taking: Taxanes, CYP3A4 inhibitors

Disqualifiers: Active brain metastases, Severe neurotoxicity, others

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

Compensation: Varies

Number of Visits: 10

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, TH1902, a peptide-drug conjugate, for individuals with various advanced solid cancers unresponsive to standard treatments like chemotherapy or radiation. The trial aims to determine the right dose, expand on initial findings, and evaluate specific cancer types to assess TH1902's effectiveness. Individuals with cancers such as certain types of breast cancer, ovarian cancer, or others resistant to current treatments and impacting daily life may qualify. This trial targets those whose cancer has not improved with standard therapies and who seek alternative options. As a Phase 1 trial, the research focuses on understanding how TH1902 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as chemotherapy, biologic therapy, immunotherapy, radiotherapy, and investigational agents, at least 4 weeks before starting the study drug. Additionally, you must not take drugs that affect certain liver enzymes (CYP3A4 or CYP3A5) within 14 days before starting the study.

Is there any evidence suggesting that TH1902 is likely to be safe for humans?

Research has shown that TH1902 is promising in terms of safety for treating certain solid tumors. In studies, patients taking TH1902 experienced few serious side effects, and no dose-limiting toxicities (DLTs) were reported, indicating that treatment doses did not reach harmful levels. Additionally, few severe treatment-related side effects occurred, and no serious issues like nerve pain, eye problems, or low white blood cell counts were observed.

These findings suggest that TH1902 is generally well-tolerated. However, it is important to remember that this treatment is still under study. Participants in the clinical trial will help gather more information about its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard cancer treatments, which often involve chemotherapy or targeted therapies, TH1902 is unique because it is a peptide-drug conjugate. This means it combines a targeting peptide with a potent anticancer drug, specifically designed to deliver the drug directly to cancer cells, potentially minimizing damage to healthy cells. Researchers are excited about TH1902 because it targets a receptor that is often overexpressed in cancer cells, which could lead to more effective and precise treatment options with fewer side effects compared to traditional therapies.

What evidence suggests that TH1902 might be an effective treatment for cancer?

Research has shown that TH1902, the investigational treatment in this trial, may help treat certain cancers. In some patients, the drug kept the disease stable for 8 to 19 months, even after discontinuation. Studies also found that TH1902 can kill cancer cells more effectively than docetaxel, a common chemotherapy drug, particularly in certain cancer cell types. Additionally, TH1902 appears to alter the tumor's immune environment, potentially aiding in cancer treatment. In early trials, 10 out of 15 patients experienced stable disease or a partial reduction in tumor size, including one patient whose tumor shrank by 53%. These findings suggest that TH1902 could be effective for cancers unresponsive to other treatments. ^{1 5 6 7 8}

Who Is on the Research Team?

Funda Meric-Burnstam, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

Adults with advanced solid tumors that have not responded to standard treatments, including chemotherapy and surgery. Participants must be in relatively good health otherwise (ECOG status of 0-1), have a life expectancy of at least 3 months, and measurable disease. Women who can become pregnant and men with partners who can become pregnant must use effective contraception.

Inclusion Criteria

I have chronic HBV, a history of HCV, or am on HCV treatment.

My ovarian cancer is high grade and not responding to standard treatments.

I agree to use effective birth control methods during and after treatment as required.

Exclusion Criteria

Your ECG shows a specific measurement called QTc that is longer than 470 milliseconds.

You have any of the following blood-related issues before starting the study.

I haven't had cancer treatments or experimental drugs in the last 4 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Patients with recurrent advanced solid tumors receive TH1902 to determine the maximum tolerated dose

21 days

3 visits (in-person)

Dose Expansion

Selected patient populations receive TH1902 to further assess safety and efficacy

12 weeks

4 visits (in-person)

Dose Optimization

Patients with high grade serous ovarian cancer receive TH1902 to optimize dosing regimen

28-day cycles

3 visits (in-person) per cycle

Basket Expansion

Selected cancer types receive TH1902 to evaluate efficacy across different cancers

Varies per patient

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TH1902

Trial Overview TH1902 is being tested on patients with various types of cancer such as breast, ovarian, endometrial, skin (melanoma), thyroid, lung (SCLC), prostate cancers and others expressing SORT1. The trial has four parts: dose escalation for all comers; expansion for specific cancers; optimization for high-grade serous ovarian cancer; basket expansion based on earlier results.

How Is the Trial Designed?

Group I: TH1902 Experimental Treatment 1 Intervention

TH1902 peptide-drug conjugate

Who Is Running the Clinical Trial?

Theratechnologies

Lead Sponsor

Trials

11

Recruited

1,900+

Altasciences Company Inc.

Industry Sponsor

Trials

18

Recruited

860+

PPD DEVELOPMENT, LP

Industry Sponsor

Trials

167

Recruited

38,000+

David Simmons

PPD DEVELOPMENT, LP

Chief Executive Officer since 2012

BSc in Applied Science from Georgia Institute of Technology

Martina Flammer

PPD DEVELOPMENT, LP

Chief Medical Officer since 2024

MD

PPD Development, LP

Industry Sponsor

PPD

Industry Sponsor

Trials

162

Recruited

36,600+

Dr. Austin Smith

PPD

Chief Medical Officer since 2020

Doctor of Medicine from the Royal College of Surgeons in Ireland

David Simmons

PPD

Chief Executive Officer since 2012

Bachelor’s degree in Applied Mathematics and Industrial Management from Carnegie Mellon University

altasciences

Collaborator

Trials

3

Recruited

140+

Windtree Therapeutics

Industry Sponsor

Trials

17

Recruited

1,500+

Syneos Health

Collaborator

Trials

181

Recruited

69,600+

Innovaderm Research Inc.

Collaborator

Trials

49

Recruited

3,200+

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.3081

Long-term efficacy, safety and PK data of TH1902 ... Three pts exhibited RECIST 1.1 confirmed long-term stabilizations of disease, even after drug discontinuation, which ranged from 8 to 19 mos ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9031804/

The Peptide-Drug Conjugate TH1902: A New Sortilin ... The results show that TH1902 induces more efficiently apoptosis in both cell lines when compared to docetaxel especially in SKOV3 cells. Overall ...

3. clin.larvol.com clin.larvol.com/trial-detail/NCT04706962

TH1902 in Patients With Advanced Solid Tumors This updated analysis will present further data on long-term efficacy, safety and PK from Parts 1 and 2, focusing specifically on patients receiving sudocetaxel ...

4. frontiersin.org frontiersin.org/journals/immunology/articles/10.3389/fimmu.2024.1355945/full

Sudocetaxel Zendusortide (TH1902) triggers the cGAS ... This is the first evidence that TH1902 exerts its antitumor activity, in part, through modulation of the immune tumor microenvironment.

5. asco.org asco.org/abstracts-presentations/ABSTRACT423154

Sudocetaxel zendusortide (TH1902), a novel ... In 15 evaluable pts in Part 1 clinical benefit was observed in 10 pts: 1 PR (prostate with 53% decrease in target lesion) and 9 SD. PK and SORT1 expression ...

6. theratech.com theratech.com/news-releases/news-release-details/theratechnologies-present-long-term-efficacy-safety-and/

News This updated analysis will present further data on long-term efficacy, safety and PK from Parts 1 and 2, focusing specifically on patients ...

7. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.e15113

Efficacy and safety data from Ph1b, dose optimization trial ... Weekly administration of TH1902 resulted in an improved safety profile, with no DLTs, few ≥Gr 3 TRAEs, and no ≥Gr 3 neuropathy, ocular or neutropenia events.

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34314556/

TH1902, a new docetaxel-peptide conjugate for the ... Altogether, the data demonstrates the high in vivo efficacy and safety of TH1902 against TNBC through a SORT1 receptor-mediated mechanism. This property ...