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 | 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 |
RXDX-105 is an investigational small molecule being studied for the treatment of solid tumors. It is a potent RET inhibitor that was evaluated in a Phase 1 clinical trial in patients with advanced lung cancer and other solid tumors. The drug is not approved and remains in clinical development.
RXDX-105 targets the RET protein, a receptor tyrosine kinase. It is described as a potent RET inhibitor. The drug was studied in a Phase 1 trial for advanced lung cancer and other solid tumors, though the trial did not select patients based on RET biomarkers.
RXDX-105 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The drug is an investigational small molecule in Phase 1 clinical development for solid tumors. Roche is conducting the clinical research on this RET inhibitor.
RXDX-105 is in Phase 1 clinical development. It has completed one Phase 1 trial, which was an uncontrolled, non-randomized study. The drug is investigational and has not been approved by regulatory authorities. No active trials are currently listed for RXDX-105.
RXDX-105 has been studied in one completed clinical trial, NCT01877811. This Phase 1 study enrolled 143 participants with advanced lung cancer and other solid tumors in the United States. The trial was open to adults aged 18 years and older of all sexes.