Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as LBQ707
Gimatecan · 5 trials · 4 indications
For purposes of estimating the MTD, 5 dose levels of Gimatecan initially considered. These dose levels are 3 mg, 5 mg, 7.5 mg, 8.75 mg, and 10 mg orally per cycle. Dose escalation based on toxicities observed through the first cycle.
| Arm | Type | Description |
|---|---|---|
| Gimatecan | EXPERIMENTAL | Gimatecan Starting dose: 0.6 mg capsules administered orally once daily. |
| LBQ707 | EXPERIMENTAL | - |
| Daily times five schedule | EXPERIMENTAL | - |
| Continuous schedule, twice daily | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Gimatecan | DRUG | Starting dose: 0.6 mg capsules administered orally once daily. |
Inclusion Criteria: 1. Patients with MDS with \>/= 5% blasts or IPSS risk group intermediate (1 or 2) or high (i.e., IPSS score 0.5 or higher). 2. Patients must have failed prior therapy with either chemotherapy (e.g., ara-C-based chemotherapy, etc) or biologic agents (e.g., hypomethylating agents,...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
Gimatecan is an investigational small molecule being studied in oncology for advanced solid tumors, solid tumors, and myelodysplastic syndromes. It has been evaluated in Phase 1 clinical trials in patients with these conditions. It is not an approved therapy and remains in clinical development.
Gimatecan targets topoisomerase 1 (TOP1) and acts as an inhibitor of this enzyme. By inhibiting TOP1, it interferes with DNA replication and transcription in cancer cells. This mechanism underlies its investigation as an anticancer agent in solid tumors and myelodysplastic syndromes.
Gimatecan is being developed by Novartis AG, which trades under the ticker NVS. Novartis has sponsored the clinical trials evaluating the drug in advanced solid tumors and myelodysplastic syndromes.
Gimatecan is in Phase 1 clinical development. All reported trials are Phase 1 studies, and the drug is investigational, meaning it has not been approved by the FDA for any indication.
Gimatecan has been studied in completed Phase 1 trials including NCT00493571 in myelodysplastic syndromes, NCT00487058 and NCT00441610 in Japanese patients with advanced solid tumors, and NCT00420485 in adult patients with advanced solid tumors across multiple countries.
Yes, Gimatecan is also known as LBQ707. The Phase 1 dose escalation study NCT00487058 refers to the drug as LBQ707 (Gimatecan), confirming they are the same agent.