Neoplasms

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Thyroid Diseases

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Female Urogenital Diseases and Pregnancy Complications

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TH1902

Lynn Douglas

Kathya Daigle

Rachael Gorney

Ira Winer, MD

Yvette Cole

Manish Sharma, MD

Terry Burke, RN

Christine Nocera

Satish Shah, MD

Jessica Bondurant, BSc

Minal Barve, MD

Amanda Eckert

Funda Meric-Bernstam, MD

Sonia Yacini

Diane Provencher, MD

Funda Meric-Burnstam, MD

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.

This first-in-human study was initially designed as a Phase 1, multi-center, open-label study, with 2 sequential parts in which TH1902 was administered once every 3 weeks (Q3W):

Part 1 (dose escalation): was comprised of 18 patients with recurrent advanced solid tumors (all comers) that had relapsed or were refractory to standard chemotherapy, surgery, radiation therapy, and for which no known effective therapies existed.

Part 2 (dose expansion): was comprised of 18 patients from selected 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.

Following emerging data from Parts 1 and 2, the Sponsor has made the decision to pause the enrollment of patients in Part 2 of the study and revisit the study design to improve the risk-benefit ratio. Patients who were enrolled in Part 2 of the study that are still benefiting from TH1902 administration will continue following the protocol for Part 2. The study will resume with enrollment in Part 3 and TH1902 will be administered on 3 consecutive weeks followed by 1 week of rest (3/1), i.e., on Days 1, 8 and 15 of a 28-day cycle, and in the following population:

Part 3 (dose optimization): will comprise approximately 16 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.

Upon completion of Part 3, an ad hoc interim analysis will be conducted to select at least 2 dosing arms that will offer an acceptable risk-benefit ratio for dose expansion in Part 4 with the following population:

Part 4 (basket expansion): will comprise approximately 20 patients per dose level, per 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.

This first-in-human study is designed as a multi-center, open-label, with 4 sequential parts:

Part 1 (dose escalation), Part 2 (dose expansion), Part 3 (dose optimization), Part 4 (basket expansion).

TH1902 in Patients With Advanced Solid Tumors

A Phase 1, Open-Label, Dose Escalation and Expansion Study of TH1902 in Patients With Advanced Solid Tumors

Toxicities will be assessed in each patient by tracking the occurrence of graded Adverse Events (AEs). AEs will be graded according to the National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) v5.0.

The MTD will be defined as the dose level at which no more than one of six patients experiences a dose limiting toxicity (DLT) after 21 days of treatment have occurred, with the next higher dose having at least 2 of 3 or 2 of 6 patients experiencing a DLT.

The RP2D will be determined following the determination of the MTD and an overall assessment of safety as determined by the Safety Committee.

Anti-tumor activity (efficacy) will be assessed in all patients. Determination of the antitumor activity of TH1902 as per Response Evaluation Criteria in Solid Tumors (RECIST 1.1).

The plasma concentration will be measured as part of pharmacokinetic (PK) testing.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
TH1902 in Patients With Advanced Solid Tumors	NCT04706962	Solid Tumor TNBC - Triple-N... Hormone Recepto... Epithelial Ovar... Endometrial Can... Cutaneous Melan... Thyroid Cancer Small-cell Lung... Prostate Cancer SORT1+ Cancers	TH1902	18 Years -	Theratechnologies
TH1902 in Patients With Advanced Solid Tumors	NCT04706962	Solid Tumor TNBC - Triple-N... Hormone Recepto... Epithelial Ovar... Endometrial Can... Cutaneous Melan... Thyroid Cancer Small-cell Lung... Prostate Cancer SORT1+ Cancers	TH1902	18 Years -	Theratechnologies

Spots Global Cancer Trial Database for sort1+ cancers