Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RXDX-105 · 1 trial · 1 indication
From signing of the informed consent up to approximately 12 months
From signing of the informed consent up to approximately 12 months
To further assess the safety profile and tolerability of RXDX-105 at the RP2D
| Arm | Type | Description |
|---|---|---|
| RXDX-105 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| RXDX-105 | DRUG | During Phase 1/1b, subjects will receive daily oral doses of RXDX-105 in 28-day cycles (except for Day 2 of Cycle 1). To determine the recommended Phase 2 dose (RP2D), doses will be administered in an escalated fashion starting at 20 mg/day. During Phase 1b, subjects will be administered the RP2D in 28-day treatment cycles until documented radiographic progression, unacceptable toxicity, withdrawal of consent, or protocol specified parameters to stop treatment. |
Inclusion Criteria for Phase 1b: 1. Patients must have histologically or cytologically confirmed advanced solid tumors with a histology and/or molecular alteration of interest as defined in Section 4, detected by a CLIA-certified or equivalently accredited diagnostic laboratory • Squamous NSCLC...
| 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 |
RXDX-105 is an investigational small molecule developed by Roche Holding AG for the treatment of advanced solid tumors, including lung cancer. It is a potent RET inhibitor studied in a Phase 1 clinical trial. RXDX-105 has not been approved by the FDA and remains in clinical development.
RXDX-105 was studied for the treatment of advanced solid tumors, including advanced lung cancer. It is an investigational agent and is not approved for any indication. Its only clinical trial enrolled patients with solid tumors, and the study has been completed.
RXDX-105 is a potent RET inhibitor. It targets the RET kinase, a receptor tyrosine kinase whose alterations drive certain solid tumors, including lung cancers. By inhibiting RET, RXDX-105 is designed to block signaling that promotes tumor growth in RET-altered cancers.
RXDX-105 is developed by Roche Holding AG, which trades on the OTC market under the ticker RHHBY. Roche holds the asset and sponsored its clinical development program in advanced solid tumors.
RXDX-105 is in Phase 1. Its single clinical trial, NCT01877811, has been completed, and no trials are currently active. RXDX-105 is investigational and has not received FDA approval for any indication.
RXDX-105 was evaluated in one Phase 1 trial, NCT01877811, titled Study of RXDX-105, Potent RET Inhibitor in Patients With Advanced Lung Cancer and Other Solid Tumors. The trial enrolled 143 patients in the United States and has been completed. It was an uncontrolled study without randomization or blinding.