Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ATRN-119 · 3 trials · 8 indications
This will be judged by whether patients are able to have their planned surgery within 6 weeks after the study treatment, and whether there are no problems during surgery that the study doctor believes were caused by the study treatment.
Researchers will measure how many patients have a strong treatment response in the affected lymph nodes that were treated with radiation, based on what is seen when the tissue is examined.
The DLT evaluation period is 28 days from initiation of study treatment (Cycle 1), except in cases of persistent neutropenia meeting hematologic DLT criteria, for which the observation window will extend to 42 days from treatment initiation. DLTs are defined in the protocol.
Treatment-emergent AEs (TEAEs) will be collected and Clinical Laboratory Evaluations will be performed
| Arm | Type | Description |
|---|---|---|
| Treatment Arm | EXPERIMENTAL | Patients will take 800mg of ATRN-119 every day for 10 days. On day 3 of dosing, they will return to clinic for 1 fraction of SBRT. |
| Part A Dose Escalation Dose Level 1: ATRN-119 + Decitabine | EXPERIMENTAL | Patients will take 750 mg of ATRN-119 by mouth once per day on Days 1-28 of each 28-day cycle and 20 mg/m\^2 of decitabine given intravenously (IV) on Days 1-5. Patients may continue treatment for up to 24 cycles, or until disease progression, unacceptable toxicity, or withdrawal. |
| Part A Dose Escalation Dose Level 2: ATRN-119 + Decitabine | EXPERIMENTAL | Patients will take 1000 mg of ATRN-119 by mouth once per day on Days 1-28 of each 28-day cycle and 20 mg/m\^2 of decitabine given intravenously (IV) on Days 1-5. Patients may continue treatment for up to 24 cycles, or until disease progression, unacceptable toxicity, or withdrawal. |
| Part A Dose Escalation Dose Level -1: ATRN-119 + Decitabine | EXPERIMENTAL | Patients will take 500 mg of ATRN-119 by mouth once per day on Days 1-28 of each 28-day cycle and 20 mg/m\^2 of decitabine given intravenously (IV) on Days 1-5. Patients may continue treatment for up to 24 cycles, or until disease progression, unacceptable toxicity, or withdrawal. |
| Part B Dose Expansion: ATRN-119 + Decitabine | EXPERIMENTAL | Patients will take the recommended phase 2 dose (RP2D) of ATRN-119 as determined in the dose escalation portion of the trial once per day on Days 1-28 of each 28-day cycle and 20mg/m\^2 of decitabine given intravenously (IV) on Days 1-5. Patients may continue treatment for up to 24 cycles, or until disease progression, unacceptable toxicity, or withdrawal. |
| 50mg ATRN-119 | EXPERIMENTAL | Once daily oral administration. |
| 100mg ATRN-119 | EXPERIMENTAL | Once daily oral administration. |
| 200mg ATRN-119 | EXPERIMENTAL | Once daily oral administration. |
| 350mg ATRN-119 | EXPERIMENTAL | Once daily oral administration. |
| 400mg ATRN-119 | EXPERIMENTAL | Twice daily oral administration. |
| 1100mg ATRN-119 | EXPERIMENTAL | Once daily oral administration |
| 1300mg ATRN-119 | EXPERIMENTAL | Once daily oral administration |
| 1500mg ATRN-119 | EXPERIMENTAL | Once daily oral administration |
| 650mg ATRN-119 | EXPERIMENTAL | Twice daily oral administration. |
| 750mg ATRN-119 | EXPERIMENTAL | Twice daily oral administration. |
| 550mg ATRN-119 | EXPERIMENTAL | Once or twice daily oral administration |
| 800 mg ATRN-119 | EXPERIMENTAL | Once daily oral administration |
| Name | Type | Description |
|---|---|---|
| ATRN-119 | DRUG | ATRN-119 at 800 mg QD (every day) for 10 days |
| Stereotactic Body Radiation Therapy (SBRT) | RADIATION | 10 Gy administered to nodal disease (neck) only on day 3 of ATRN-119 dosing |
| Decitabine | DRUG | Decitabine is provided as a 50mg injection in a single-dose vial. |
Inclusion Criteria: * Age ≥ 18 * Patients that have been diagnosed with HPV-positive throat cancer (OPSCC) at an early stage (stage I or II), confirmed by a biopsy. * Patients' blood calcium level is within a safe range * Patients' blood, kidney, and liver health are strong enough, shown through sp...