TH1902 for Cancer

Recruiting at 7 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

70 Participants Needed

Trial Summary

What is the purpose of this trial?

Open label first-in-human study of TH1902 in solid cancer, with 4 sequential parts: Part 1 (dose escalation): patients with recurrent advanced solid tumors (all comers) that have relapsed or are refractory to standard chemotherapy, surgery, radiation therapy, and for which no known effective therapies exist. Part 2 (expansion): selected patient populations with recurrent advanced TNBC, HR+ breast cancer, epithelial ovarian cancer, endometrial cancer, cutaneous melanoma, thyroid cancer, SCLC, prostate cancer and other cancers known to express SORT1 that are refractory to standard therapy. Part 3 (optimization): patients diagnosed with histologically or cytologically confirmed high grade serous ovarian cancer, including high grade peritoneal or fallopian tube cancer, or high grade endometrioid cancer, that is refractory or resistant to standard therapies, should not be considered platinum sensitive, and where current therapy is not considered to be providing benefit. Part 4 (basket expansion): selected cancer type diagnosed with histologically or cytologically confirmed cancers, where TH1902 has been studied and/or showed activity (in Parts 1 to 3), that is refractory or resistant to standard therapies, and where current therapy is not considered to be providing benefit.

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.

Research Team

Funda Meric-Burnstam, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+