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Also known as [14C]-etrumadenant, AB928
Etrumadenant · 6 trials · 24 indications
A positive response is defined as a ≥40% increase in the number of infiltrating cluster of differentiation 3 (CD3) + T cells between the pre-treatment biopsy at baseline and the post-treatment RP specimen. Thus, a negative response is a \<40% increase. The primary endpoint will include all enrolled subjects who receive at least 1 dose of study treatment and undergo RP. Analysis of the primary endpoint will be performed for each cohort independently
ORR defined as the composite proportion of participants with a Prostate Specific Antigen (PSA) and/or radiographic complete response (CR) and partial response (PR) determined by the investigator according to the Prostate Cancer Working Group 3 (PCWG3) criteria
| Arm | Type | Description |
|---|---|---|
| Cohort A (atezolizumab monotherapy) | EXPERIMENTAL | Participants receive one (1) cycle of atezolizumab, 1200mg intravenously (IV) over 30-60 minutes on day 1 of a 14 day cycle. Radical Prostatectomy (RP) will occur 21 days (+/- 7 days) following the final dose of atezolizumab. No further study therapy will be administered following RP. |
| Cohort B (atezolizumab, etrumadenant) | EXPERIMENTAL | Participants will receive one (1) cycle of atezolizumab, 1200mg intravenously (IV) over 30-60 minutes on day 1 of a 14 day cycle and etrumadenant will be taken at a dose of 150mg PO, once daily, until 48 hours prior to RP, for at least 12 days. Radical Prostatectomy (RP) will occur 21 days (+/- 7 days) following the final dose of atezolizumab. No further study therapy will be administered following RP. |
| Cohort C (atezolizumab, tocilizumab) | EXPERIMENTAL | Participants will receive one (1) cycle of neoadjuvant atezolizumab and one (1) cycle of tocilizumab, 6mg/kg will be administered IV on day 1 of a 14 day IV prior to RP; atezolizumab will be administered in an identical fashion as Cohort A. RP will occur 21 days (+/- 7 days) following the final dose of atezolizumab. No further study therapy will be administered following RP. |
| Stage 1 and 2: Etrumadenant + zimberelimab + enzalutamide | EXPERIMENTAL | Participants will receive oral etrumadenant in combination with intravenous (IV) zimberelimab and standard oral enzalutamide |
| Stage 2: enzalutamide | ACTIVE_COMPARATOR | Participants will receive standard oral enzalutamide |
| Stage 1 and 2: Etrumadenant + zimberelimab + docetaxel | EXPERIMENTAL | Participants will receive oral etrumadenant in combination with IV zimberelimab and standard IV docetaxel |
| Stage 2: docetaxel | ACTIVE_COMPARATOR | Participants will receive standard dose of IV docetaxel |
| Stage 1 and 2: Etrumadenant + zimberelimab | EXPERIMENTAL | Oral etrumadenant in combination IV zimberelimab |
| Stage 2: Etrumadenant + zimberelimab + quemliclustat | EXPERIMENTAL | Participants will receive oral etrumadenant in combination with IV zimberelimab and IV quemliclustat |
| Stage 2: Etrumadenant + quemliclustat | EXPERIMENTAL | Participants will receive oral etrumadenant in combination with IV quemliclustat |
| Stage 1: Etrumadenant + zimberelimab PK Sub-Study | EXPERIMENTAL | Participants will receive oral etrumadenant in combination with IV zimberelimab |
| Stage 1 and 2: Etrumadenant + SG | EXPERIMENTAL | Participants will receive oral etrumadenant in combination with IV SG. |
| Stage 1 and 2: Etrumadenant + Zimberelimab + SG | EXPERIMENTAL | Participants will receive oral etrumadenant in combination with IV zimberelimab and SG. |
| Dose Escalation Arm A | EXPERIMENTAL | Dose escalation is a 3+3 design, including a Dose Limiting Toxicity (DLT) evaluation period. The RDE of etrumadenant will be determined in this part with escalating doses of etrumadenant in combination with standard doses of carboplatin/pemetrexed chemotherapy regimen in participants with Non-Small Cell Lung Cancer. |
| Dose Escalation Arm B | EXPERIMENTAL | Dose escalation is a 3+3 design, including a Dose Limiting Toxicity (DLT) evaluation period. The RDE of etrumadenant will be determined in this part with escalating doses of etrumadenant in combination with standard doses of carboplatin/pemetrexed chemotherapy regimen and pembrolizumab in participants with Non-Small Cell Lung Cancer. |
| Dose Expansion Arm 1 | EXPERIMENTAL | Zimberelimab will be administered in combination with standard carboplatin and pemetrexed chemotherapy regimen in participants with Non-Small Cell Lung Cancer harboring a sensitizing EGFR mutation. |
| Dose Expansion Arm 2 | EXPERIMENTAL | The etrumadenant at RDE determined from the dose escalation phase will be administered in combination with standard carboplatin and pemetrexed chemotherapy regimen and zimberelimab in participants with Non-Small Cell Lung Cancer harboring a sensitizing EGFR mutation. |
| Dose Escalation | EXPERIMENTAL | Dose escalation is a 3+3 design, including a Dose Limiting Toxicity (DLT) evaluation period. The RDE of etrumadenant will be determined in this part with escalating doses of etrumadenant in combination with the standard mFOLFOX chemotherapy regimen in participants with gastroesophageal or colorectal cancer. |
| Dose Expansion-GE | EXPERIMENTAL | The RDE of etrumadenant will be determined from the dose escalation part. Etrumadenant will be given in combination with the standard mFOLFOX chemotherapy regimen in participants with gastroesophageal cancer |
| Dose Expansion-CRC | EXPERIMENTAL | The RDE of etrumadenant will be determined from the dose escalation part. Etrumadenant will be given in combination with the standard mFOLFOX chemotherapy regimen in participants with colorectal cancer |
| Dose Escalation-Arm A | EXPERIMENTAL | Dose escalation is a 3+3 design, including a Dose Limiting Toxicity (DLT) evaluation period. |
| Dose Escalation-Arm B | EXPERIMENTAL | Dose escalation is a 3+3 design, including a Dose Limiting Toxicity (DLT) evaluation period. |
| Dose Escalation-Arm C | EXPERIMENTAL | Dose escalation is a 3+3 design, including a Dose Limiting Toxicity (DLT) evaluation period. |
| Dose Expansion-TNBC-Arm 1 | EXPERIMENTAL | The dose given will be determined from the dose escalation part (Arm A). |
| Dose Expansion-Ovarian Cancer-Arm 2 | EXPERIMENTAL | The dose given will be determined from the dose escalation part (Arm A). |
| Dose Expansion-TNBC-Arm 3 | EXPERIMENTAL | The dose given will be determined from the dose escalation part (Arm B). . |
| Dose Expansion-TNBC-Arm 4 | EXPERIMENTAL | The dose expansion will be determined from the dose escalation part (Arm C). |
| Dose Expansion-advanced clear-cell RCC | EXPERIMENTAL | Etrumadenant at RP2D + zimberelimab |
| Dose Expansion-mCRPC | EXPERIMENTAL | Etrumadenant at RP2D + zimberelimab |
| Name | Type | Description |
|---|---|---|
| Atezolizumab | DRUG | Given IV |
| Tocilizumab | DRUG | Given IV |
| Etrumadenant | DRUG | Given Orally |
| Zimberelimab | DRUG | Zimberelimab is an anti-PD-1 antibody |
| Quemliclustat | DRUG | Quemliclustat is a Cluster of Differentiation (CD)73 Inhibitor. |
| Enzalutamide | DRUG | Enzalutamide is an androgen receptor inhibitor |
| Docetaxel | DRUG | Docetaxel is type of chemotherapy |
| SG | DRUG | Sacituzumab govitecan is an antibody-drug conjugate |
| Carboplatin | DRUG | Carboplatin administered as part of standard chemotherapy regimen |
| Pemetrexed | DRUG | Pemetrexed administered as part of standard chemotherapy regimen |
| Pembrolizumab | DRUG | Pembrolizumab is a humanized anti-PD-1 monoclonal antibody |
| mFOLFOX | DRUG | Oxaliplatin, Leucovorin and 5-fluorouracil given as part of standard mFOLFOX chemotherapy regimen |
| IPI-549 | DRUG | IPI-549 is a phosphoinositide-3-kinase-gamma inhibitor for oral use |
| Pegylated liposomal doxorubicin (PLD) | DRUG | Doxil is an anthracycline topoisomerase II inhibitor that is encapsulated in liposomes for intravenous (IV) use |
| nanoparticle albumin-bound paclitaxel (NP) | DRUG | NP is a microtubule inhibitor for intravenous (IV) use |
Inclusion Criteria: 1. Histologically confirmed adenocarcinoma of the prostate. a. Subjects with small cell or neuroendocrine PC are not eligible. 2. Eligible for radical prostatectomy as determined by urologic oncology surgeon, and subject consents to proceeding with radical prostatectomy. ...
Etrumadenant is an investigational small molecule being studied in oncology for several solid tumor types. These include gastroesophageal cancer, metastatic and non-small cell lung cancer, prostate adenocarcinoma, castration-resistant prostatic neoplasms, and triple-negative breast cancer. It is being developed by Arcus Biosciences, Inc. and remains in clinical development.
Etrumadenant targets the adenosine receptors ADORA2A and ADORA2B as an antagonist. By blocking these receptors, it aims to modulate adenosine-mediated immunosuppression in the tumor microenvironment. This mechanism is being explored in combination immunotherapy regimens for various cancers.
Etrumadenant is being developed by Arcus Biosciences, Inc., which trades under the ticker RCUS. The company is responsible for its clinical development across multiple cancer indications.
Etrumadenant is in Phase 1 clinical development. It has not been approved by the FDA and is considered investigational. The Phase 1 program includes completed and recruiting trials evaluating the drug in different cancer types.
Etrumadenant has been studied in several clinical trials, including NCT04381832 for metastatic castration-resistant prostate cancer, NCT03846310 for lung cancer, NCT03821246 for localized prostate cancer, and NCT03720678 for gastrointestinal malignancies. These trials include Phase 1 and Phase 2 studies, with some completed and one recruiting.
Yes, [14C]-etrumadenant is an alternative name for etrumadenant. The [14C] label indicates a carbon-14 radiolabeled version used in research, but it refers to the same active drug substance.