ACE-106 / Acerand Therap - LARVOL DELTA

Study of ACE-86225106 to Treat Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=298 | Active, not recruiting | Sponsor: Acerand Therapeutics (Shanghai) Limited | Recruiting ➔ Active, not recruiting

Enrollment closed • Monotherapy • Breast Cancer • Castration-Resistant Prostate Cancer • Estrogen Receptor Positive Breast Cancer • Genito-urinary Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor • HRD

Updated results from a first-in-human phase 1,2 study of ACE-106, a highly selective and potentially best-in-class PARP1 inhibitor in advanced solid tumors (AACR 2026) - P1/2 | "ACE-106 was well tolerated and showed promising efficacy and excellent PK properties in heavily pre-treated advanced solid tumors. The clinical profile suggests a best-in-class selective PARP1i potential to replace pan-PARPi and justify further development of ACE-106-based combination therapy. Disclosure: This abstract used generative AI to help revise content written by authors."

First-in-human • Metastases • P1/2 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor • BRCA1 • BRCA2 • CDK12 • PALB2

Acerand Therapeutics Updates the Phase I/II Study of ACE-106 (ACE-86225106), a highly selective and Potentially Best-in-class PARP1 Inhibitor, in Advanced Solid Tumors (Businesswire) - "As of February 5, 2026, 57 heavily pretreated patients, with a median three prior lines of therapies, had received ACE-106....Among evaluable homologous recombination repair-mutated (HRRm) patients, the objective response rate (ORR) was 32%, with a disease control rate (DCR) of 58%....In patients with HRRm metastatic castration-resistant prostate cancer (mCRPC), ACE-106 achieved an ORR of 50% and a PSA50 response rate of 37%, and a median progression-free survival (mPFS) of 7.4 months. In PARPi-naïve HRRm ovarian cancer, ACE-106 demonstrated an ORR of 67% and a DCR of 100%....Detailed results will be presented at the AACR Annual Meeting 2026 (Abstract CT064)....Acerand plans to initiate a randomized Phase II study evaluating ACE-106 in combination with an androgen receptor pathway inhibitor (ARPI) versus ARPI alone in prostate cancer."

First-in-human • New P2 trial • P1/2 data • Castration-Resistant Prostate Cancer • Ovarian Cancer

Discovery of a highly potent and selective PARP1 inhibitor with superior PK and safety profiles (AACR 2024) - "Taken together, ACE-86225106 is a highly potent, selective PARP1 inhibitor with excellent PK and safety profile and expected to have a better safety profile, deeper and more durable clinical responses, and broader utility in the clinic as a preferred combination partner with other anti-cancer therapies. A phase 1 clinical trial to evaluate its safety, PK, and clinical utility is to begin in early 2024."

Clinical • First-in-human • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • BRCA • CD34 • HRD • PARP2

The efficacy and safety of a selective PARP1 inhibitor ACE-86225106 in patients with advanced solid tumors: Preliminary results from a first-in-human phase 1/2 study. (ASCO 2025) - P1/2 | "Preliminary data indicate that ACE-86225106 is well tolerated and shows promising efficacy in heavily pre-treated advanced solid tumors."

Clinical • Metastases • P1/2 data • Breast Cancer • Fallopian Tube Cancer • Genito-urinary Cancer • Lung Cancer • Oncology • Prostate Cancer • Solid Tumor • Squamous Cell Carcinoma • BRCA • PARP2

The efficacy and safety of a selective PARP1 inhibitor ACE-86225106 in patients with advanced solid tumors: preliminary results from a first-in-human phase 1/2 study (EORTC-NCI-AACR 2024) - P1/2 | "Preliminary data indicate that ACE-86225106 is well tolerated and shows promising efficacy in heavily pre-treated advanced solid tumors."

Clinical • Metastases • P1/2 data • Bladder Cancer • Fallopian Tube Cancer • Genito-urinary Cancer • Lung Cancer • Oncology • Prostate Cancer • Solid Tumor • Squamous Cell Carcinoma • BRCA • MUC16 • PARP2

Study of ACE-86225106 to Treat Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=298 | Recruiting | Sponsor: Acerand Therapeutics (Shanghai) Limited

Metastases • Monotherapy • New P1/2 trial • Breast Cancer • Genito-urinary Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor