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...
ATRN-119 is an investigational small molecule being studied for advanced solid tumors, HPV positive oropharyngeal squamous cell carcinoma, and acute myeloid leukemia. It is in Phase 1 clinical development for these oncology indications.
ATRN-119 targets ATR, a protein kinase involved in the DNA damage response. By inhibiting ATR, the drug is being studied for its potential to disrupt cancer cell survival mechanisms.
ATRN-119 is being developed by Aprea Therapeutics, Inc., a biopharmaceutical company. The company's stock is listed under the ticker symbol APRE.
ATRN-119 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials are ongoing or planned to evaluate its safety and efficacy.
ATRN-119 is being studied in three Phase 1 trials. NCT04905914 evaluated ATRN-119 in patients with advanced solid tumors and is completed. NCT07578467 will study ATRN-119 combined with nodal SBRT for HPV positive oropharyngeal squamous cell carcinoma. NCT07617363 will study ATRN-119 with decitabine in TP53-mutated AML or higher-risk MDS.
ATRN-119 is the primary name for this investigational drug. No alternative names have been identified in the available information.