Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TH1902 · 1 trial · 10 indications
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.
| Arm | Type | Description |
|---|---|---|
| TH1902 | EXPERIMENTAL | TH1902 peptide-drug conjugate |
| Name | Type | Description |
|---|---|---|
| TH1902 | DRUG | Intravenous infusion |
Inclusion Criteria: Parts 1, 2, 3 and 4 Patients must meet all the following criteria to be eligible to participate in the study: 1. Are ≥18 years old males or females. 2. Are capable of understanding and have voluntarily signed the informed consent document and willing to comply with study requi...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
TH1902 is an investigational small molecule being developed for the treatment of advanced solid tumors, including triple-negative breast cancer, hormone receptor-positive breast cancer, epithelial ovarian cancer, endometrial cancer, cutaneous melanoma, thyroid cancer, small-cell lung cancer, and prostate cancer. It is currently in Phase 1 clinical development.
TH1902 is being developed by Windtree Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol WINT. The company is conducting clinical trials to evaluate the safety and efficacy of TH1902 in patients with advanced solid tumors.
TH1902 is in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The ongoing Phase 1 trial is actively enrolling or has completed enrollment, with the study status listed as active but not recruiting.
TH1902 is being studied in a Phase 1 clinical trial with the identifier NCT04706962, titled "TH1902 in Patients With Advanced Solid Tumors." The trial is enrolling approximately 70 participants across the United States and Canada, with a minimum age of 18 years.
TH1902 is being evaluated for the treatment of multiple solid tumor types, including triple-negative breast cancer, hormone receptor-positive breast cancer, epithelial ovarian cancer, endometrial cancer, cutaneous melanoma, thyroid cancer, small-cell lung cancer, and prostate cancer. The trial also includes patients with SORT1+ cancers.
The Phase 1 clinical trial of TH1902 is an uncontrolled, open-label study. It is not randomized and not double-blinded, meaning all participants receive the investigational drug without a placebo or comparator group. The trial is designed to assess the drug's safety and preliminary activity.