Drugs / Prexasertib

Trials 18

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 112 trials
Phase 1 NCT04023669 Aug 2019 → May 2023 brain cancer, medulloblastoma non-WNT/non-SHH group 3, medulloblastoma non-WNT/non-SHH group 4 St. Jude Children's Research Hospital Completed No outcome recorded
Phase 1 NCT03735446 Jan → Mar 2019 acute myeloid leukemia, myelodysplastic syndrome Dana-Farber Cancer Institute Terminated No outcome recorded Stop: Business
Phase 1 NCT03495323 May 2018 → Feb 2021 cancer Dana-Farber Cancer Institute Completed No outcome recorded
Phase 1 NCT03057145 Mar 2017 → Feb 2020 cancer Geoffrey Shapiro, MD, PhD Completed No outcome recorded
Phase 1 NCT02808650 Feb 2017 → Dec 2019 central nervous system cancer, childhood malignant neoplasm, refractory malignant neoplasm Children's Oncology Group Completed No outcome recorded
Phase 1 NCT02778126 Sep 2016 → Apr 2017 cancer of unknown primary site Eli Lilly and Company Completed No outcome recorded
Phase 1 NCT02860780 Aug 2016 → May 2017 cancer of unknown primary site, colorectal cancer, metastatic malignant neoplasm, non-small cell lung carcinoma Eli Lilly and Company Completed No outcome recorded
Phase 1 NCT02649764 May 2016 → Jul 2022 acute myeloid leukemia, chronic myelomonocytic leukemia, myelodysplastic syndrome M.D. Anderson Cancer Center Completed No outcome recorded
Phase 1 NCT02555644 Feb 2016 → Jan 2019 head and neck neoplasm Eli Lilly and Company Completed No outcome recorded
Phase 1 NCT02514603 Oct 2015 → Apr 2017 neoplasm Eli Lilly and Company Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT04095221 Sep 2019 → Feb 2025 desmoplastic small round cell tumor, rhabdomyosarcoma Memorial Sloan Kettering Cancer Center Completed No outcome recorded
Phase 25 trials
Phase 2 NCT04032080 Sep 2019 → Jun 2022 triple-negative breast carcinoma Baylor Research Institute Completed No outcome recorded
Phase 2 NCT03414047 Apr 2018 → Jun 2019 ovarian cancer Eli Lilly and Company Completed No outcome recorded
Phase 2 NCT02873975 Oct 2016 → Sep 2020 cancer of unknown primary site Dana-Farber Cancer Institute Completed No outcome recorded
Phase 2 NCT02735980 May 2016 → Jul 2017 small cell lung carcinoma Eli Lilly and Company Completed No outcome recorded
Phase 2 NCT02203513 Jan 2015 → Aug 2021 breast cancer, ovarian cancer, prostate cancer National Cancer Institute (NCI) Terminated No outcome recorded

News releases announcing trial results or a regulatory action · 13

DateIssuerRelease
2026-04-17 Acrivon Therapeutics Results Acrivon to Highlight Preclinical Data with Three Posters at AACR Demonstrating Strong ACR-368 and ACR-2316 Synergies with Immune Checkpoint Inhibitors and ADC Payloads, Revealing Broad Clinical Development Opportunities acrivon.com ↗
Additionally, ACR-368 synergized with a Topo 1 inhibitor, a payload commonly used in ADCs.
2026-03-17 Acrivon Therapeutics Results Acrivon Therapeutics to Present Pre-Clinical AP3 Data at the 2026 AACR Annual Meeting Revealing Strong Synergy of ACR-368 with ADC Topo 1 Inhibitor Payloads and of both ACR-368 and ACR-2316 with Immune Checkpoint Inhibitors acrivon.com ↗
ACR-368, a CHK1/2 inhibitor in a registrational-intent Phase 2b study, showed potent preclinical synergy with Topoisomerase 1 (Topo 1) inhibitors, commonly used payloads in antibody-drug conjugates (ADCs)
2026-01-08 Acrivon Therapeutics Results Acrivon Therapeutics Announces Positive ACR-368 Phase 2b Endometrial Cancer Clinical Data with EU Expansion to Accelerate Enrollment, Initial ACR-2316 Clinical Data, and ACR-6840, its Next AP3-Enabled Development Candidate, Targeting CDK11 acrivon.com ↗
Electronic data capture (EDC) extract from the ongoing ACR-368 registrational-intent Phase 2b monotherapy trial in OncoSignature-positive (BM+) subjects with endometrial cancer (EC) showed 39% overall response rate (ORR) and 44% in subjects with ≤2 prior lines of therapy*
2024-10-17 Acrivon Therapeutics Results Acrivon Therapeutics to Present Data Demonstrating Deployment of its AP3 Platform for Streamlined Drug Discovery and Clinical Development at Two Scientific Conferences - Human Proteome Organization World Congress and EORTC-NCI-AACR Symposium acrivon.com ↗
AP3-identified clinical biomarkers for ACR-368 led to the development of a response-predictive OncoSignature assay which has shown statistically significant prospective validation and responder enrichment in the ongoing registrational-intent Phase 2b study
2024-09-14 Acrivon Therapeutics Results Acrivon Therapeutics Reports Positive Endometrial Cancer Data from Ongoing ACR-368 Registrational Intent Phase 2 Study at ESMO, Advancement of ACR-2316 into Clinic Ahead of Timelines, and Progress on its AP3 Interactome for Proprietary Data Analysis acrivon.com ↗
Confirmed overall response rate (ORR) = 62.5% (95% CI, 30.4-86.5) observed in prospectively-selected ACR-368 OncoSignature-positive (BM+) patients with endometrial cancer
2024-04-24 Acrivon Therapeutics Results Acrivon Therapeutics Reports Initial Positive Clinical Data for ACR-368 and Pipeline Program Progress Today at Corporate R&D Event acrivon.com ↗
A 50% confirmed overall response rate observed with ACR-368 in OncoSignature-positive gynecological (ovarian and endometrial) cancers
2024-04-10 Acrivon Therapeutics Results Acrivon Therapeutics Presents Data at AACR Annual Meeting Highlighting the Capabilities of Acrivon Predictive Precision Proteomics (AP3) for the Discovery of ACR-2316, a Novel, Selective WEE1/PKMYT1 Inhibitor, and the Identification of Actionable Resistance Mechanisms to ACR-368 acrivon.com ↗
AP3 profiling uncovered actionable pathways linked to resistance mechanisms for ACR-368, a clinical-stage CHK1/2 inhibitor, and identified ultra-low dose gemcitabine (ULDG) to sensitize resistant ovarian cancer cells to ACR-368
2024-03-05 Acrivon Therapeutics Results Acrivon Therapeutics to Present Data at AACR Annual Meeting Demonstrating Power of Acrivon Predictive Precision Proteomics (AP3) Platform and its Internally-Discovered, Potent WEE1/PKMYT1 Development Candidate, ACR-2316 acrivon.com ↗
AP3 identified mechanism of resistance to ACR-368, a clinical-stage CHK1/2 inhibitor, as well as a rational combination treatment to overcome resistance through sensitization to ACR-368 via ultra-low dose gemcitabine
2023-11-09 Acrivon Therapeutics Results Acrivon Therapeutics Reports Third Quarter 2023 Financial Results and Business Highlights acrivon.com ↗
As part of our third quarter highlights, we are also pleased to provide initial clinical readouts for ACR-368 and plan to present more mature data at a major medical conference during the first half of 2024.
2023-05-09 Acrivon Therapeutics Regulatory Acrivon Therapeutics Reports First Quarter 2023 Financial Results and Business Highlights acrivon.com ↗
Based on previously-generated data, we have just received Fast Track designation from the Food and Drug Administration for the investigation of ACR-368 as a monotherapy for patients with OncoSignature-positive platinum resistant ovarian cancer and endometrial cancer.
2023-05-09 Acrivon Therapeutics Regulatory Acrivon Therapeutics Announces FDA Grants Fast Track Designation for Development of ACR-368 in Platinum-Resistant Ovarian Cancer and Endometrial Cancer acrivon.com ↗
The second Fast Track development program designation was granted for the investigation of ACR-368 as a monotherapy treatment for patients with OncoSignature positive, recurrent high-grade endometrial cancer who have received at least two prior systemic treatment regimens.
2022-06-22 Acrivon Therapeutics Regulatory Acrivon Therapeutics Receives FDA Clearance for Innovative Phase 2 Trial to Treat Ovarian, Endometrial and Urothelial Cancer Patients Based on Predicted Sensitivity to ACR-368 acrivon.com ↗
Acrivon Therapeutics, Inc ., a clinical-stage oncology therapeutics company with proprietary proteomics-based technologies driving a new era of precision medicine, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug (IND) application for its lead asset ACR-368 in a Phase 2 master protocol trial to treat patients with ovarian, endometrial and urothelial cancer based on predicted ACR-368 sensitivity.

All press releases naming this drug 13 releases

DateIssuerRelease

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 20 sources stand behind the page.

FieldValueCited text
Known as Prexasertib ClinicalTrials.gov intervention name — accepted as the source's own label NCT02808650 ↗
15

NCT02514603 ↗

NCT04095221 ↗

NCT03495323 ↗

NCT02735980 ↗

NCT03057145 ↗

NCT02778126 ↗

NCT02555644 ↗

NCT04023669 ↗

NCT03414047 ↗

NCT04032080 ↗

Show 5 more sources

Known as LY2606368 “Prexasertib (LY2606368) is a checkpoint kinase 1 (CHK1) inhibitor that is being developed as a treatment for patients with advanced cancer.” NCT03495323 ↗
3

“LY2606368” NCT02649764 ↗

NCT02873975 ↗

NCT02203513 ↗

Action Inhibit “Purpose: Prexasertib, a checkpoint kinase 1 inhibitor, demonstrated single-agent activity” PMID 29643063 ↗ Apr 2018
1

“Serine/threonine-protein kinase Chk2 inhibitor” CHEMBL3544911 ↗

Modality Small molecule — CHEMBL3544911 ↗
Route Intravenous “Prexasertib IV on day 1 of a 14 day cycle.” NCT01115790 ↗
Target CHEK1 “CHK1 inhibitor” NCT02873975 ↗
Target CHEK2 “Serine/threonine-protein kinase Chk2 inhibitor” CHEMBL3544911 ↗