ESP-01 / Esperas - LARVOL DELTA

A Study of LY2880070 and Gemcitabine in People With Ewing Sarcoma,Ewing-Like Sarcoma, and Desmoplastic Small Round Cell Tumor (clinicaltrials.gov) - P2 | N=14 | Completed | Sponsor: Memorial Sloan Kettering Cancer Center | Recruiting ➔ Completed | N=24 ➔ 14 | Trial completion date: Mar 2026 ➔ Aug 2025 | Trial primary completion date: Mar 2026 ➔ Aug 2025

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Ewing Sarcoma • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • BCOR • ETV1 • ETV4 • EWSR1 • FLI1 • WT1

A Study of LY2880070 in Participants With Advanced or Metastatic Cancer (clinicaltrials.gov) - P1/2 | N=229 | Completed | Sponsor: Esperas Pharma Inc. | Recruiting ➔ Completed | Trial completion date: Sep 2025 ➔ Apr 2025 | Trial primary completion date: Sep 2025 ➔ Apr 2025

Monotherapy • Trial completion • Trial completion date • Trial primary completion date • Breast Cancer • Colon Cancer • Colorectal Cancer • Endometrial Cancer • Gastrointestinal Cancer • Glioblastoma • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PGR

A Study of LY2880070 and Gemcitabine in People With Ewing Sarcoma,Ewing-Like Sarcoma, and Desmoplastic Small Round Cell Tumor (clinicaltrials.gov) - P2 | N=24 | Recruiting | Sponsor: Memorial Sloan Kettering Cancer Center | Trial completion date: Mar 2025 ➔ Mar 2026 | Trial primary completion date: Mar 2025 ➔ Mar 2026

Trial completion date • Trial primary completion date • Ewing Sarcoma • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • BCOR • ETV1 • ETV4 • EWSR1 • FLI1 • WT1

A Study of LY2880070 in Participants With Advanced or Metastatic Cancer (clinicaltrials.gov) - P1/2 | N=229 | Recruiting | Sponsor: Esperas Pharma Inc. | Phase classification: P1b/2a ➔ P1/2

Combination therapy • Metastases • Monotherapy • Phase classification • Breast Cancer • Colon Cancer • Colorectal Cancer • Endometrial Cancer • Gastrointestinal Cancer • Glioblastoma • Hepatology • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Pancreatic Cancer • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PGR

A Study of LY2880070 and Gemcitabine in People With Ewing Sarcoma,Ewing-Like Sarcoma, and Desmoplastic Small Round Cell Tumor (clinicaltrials.gov) - P2 | N=24 | Recruiting | Sponsor: Memorial Sloan Kettering Cancer Center | Trial completion date: Mar 2024 ➔ Mar 2025 | Trial primary completion date: Mar 2024 ➔ Mar 2025

Combination therapy • Trial completion date • Trial primary completion date • Ewing Sarcoma • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • BCOR • ETV1 • ETV4 • EWSR1 • FLI1 • WT1

A Phase 1 Expansion Cohort Study Evaluating the Safety and Efficacy of the CHK1 Inhibitor LY2880070 with Low-Dose Gemcitabine in Metastatic Pancreatic Adenocarcinoma Patients. (PubMed, Clin Cancer Res) - P1b/2a | "No evidence of clinical activity was observed for combined low dose gemcitabine and LY2880070 in this treatment refractory PDAC cohort. However, the gemcitabine/LY2880070 combination showed in vitro efficacy, suggesting that drug sensitivity for this combination in organoid cultures may not predict clinical benefit in patients."

Journal • Metastases • P1 data • Gastrointestinal Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma

A Phase 1 Expansion Cohort Study Evaluating the Safety and Efficacy of the CHK1 Inhibitor LY2880070 with Low-Dose Gemcitabine in Metastatic Pancreatic Adenocarcinoma Patients (Clin Cancer Res) - P1b/2a | N=229 | NCT02632448 | Sponsor: Esperas Pharma Inc. | "Eleven patients with PDAC were enrolled in the expansion cohort between August 27, 2020 and July 30, 2021. Four patients (36%) experienced drug-related grade 3 adverse events. No objective radiological responses were observed, and all patients discontinued the trial by 3.2 months. In contrast to the lack of efficacy observed in patients, organoid cultures derived from biopsies procured from two patients demonstrated strong sensitivity to the gemcitabine/LY2880070 combination and showed treatment-induced upregulation of replication stress and DNA damage biomarkers, including pKAP1, pRPA32, and γ-H2AX, as well as induction of replication fork instability."

P1 data • Pancreatic Ductal Adenocarcinoma

Esperas Pharma, Inc. Announces Investment from TVM Life Science Innovation I and The Fonds de solidarité FTQ (GlobeNewswire) - "Esperas Pharma, Inc...announced a follow-on investment by TVM Capital Life Science ('TVM') through its fund TVM Life Science Innovation I SCSp and the Fonds de solidarité FTQ (the 'Fonds')....With these funds, Esperas will conduct a proof-of-concept study in a genetically selected sub-population of HGSOC....This new trial will assess the efficacy of ESP-01 in combination with low-dose gemcitabine in patients with HGSOC with tumors expressing defined genetic profiles. The genetic assessments will be performed by Foundation Medicine through their Foundation One CDx test. Enrollment is expected to start in March 2023."

Enrollment status • Financing • Gynecologic Cancers • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma

A Study of LY2880070 in Participants With Advanced or Metastatic Cancer (clinicaltrials.gov) - P1b/2a | N=229 | Recruiting | Sponsor: Esperas Pharma Inc. | Completed ➔ Recruiting | N=119 ➔ 229 | Trial completion date: Jan 2022 ➔ Sep 2025 | Trial primary completion date: Jan 2022 ➔ Sep 2025

Combination therapy • Enrollment change • Enrollment open • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Breast Cancer • Colon Cancer • Colorectal Cancer • Endometrial Cancer • Gastrointestinal Cancer • Glioblastoma • Hepatology • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Pancreatic Cancer • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PGR

A phase I/II study of oral chk1 inhibitor LY2880070 in combination with low-dose gemcitabine in patients with advanced or metastatic ovarian cancer (ESMO 2022) - P1b/2a | "Conclusions This combination was generally tolerated in advanced or metastatic HGSOC. Further investigation is needed to better define biomarkers predictive of response in this patient population."

Clinical • Combination therapy • P1/2 data • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Solid Tumor • CHEK1

A Study of LY2880070 in Participants With Advanced or Metastatic Cancer (clinicaltrials.gov) - P1b/2a | N=119 | Completed | Sponsor: Esperas Pharma Inc. | Recruiting ➔ Completed | N=185 ➔ 119 | Trial completion date: Jun 2021 ➔ Jan 2022 | Trial primary completion date: Mar 2020 ➔ Jan 2022

Combination therapy • Enrollment change • Monotherapy • Trial completion • Trial completion date • Trial primary completion date • Breast Cancer • Colon Cancer • Colorectal Cancer • Endometrial Cancer • Gastrointestinal Cancer • Glioblastoma • Hepatology • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PGR

A Study of LY2880070 and Gemcitabine in People With Ewing Sarcoma or Ewing-Like Sarcoma (clinicaltrials.gov) - P2 | N=24 | Recruiting | Sponsor: Memorial Sloan Kettering Cancer Center

Combination therapy • New P2 trial • Ewing Sarcoma • Oncology • Sarcoma • Solid Tumor • ETV1 • EWSR1 • FLI1

[VIRTUAL] A phase Ib study of oral Chk1 inhibitor LY2880070 as monotherapy in patients with advanced or metastatic cancer. (ASCO 2020) - P1b/2a | "LY was tolerated in a daily BID schedule. The toxicity profile can be modulated by changing the dosing frequency from QD to BID while administering the same daily dose. LY may be a potential combination therapy with DNA damaging agents."

Clinical • Monotherapy • P1 data • Fatigue • Oncology • CYP2D6

[VIRTUAL] A phase Ib study of oral Chk1 inhibitor LY2880070 in combination with gemcitabine in patients with advanced or metastatic cancer. (ASCO 2020) - P1b/2a | "LY was tolerated in combination with lower dose GEM. The toxicity profile can be modulated by changing the dosing frequency from QD to BID while administering the same daily dose. LY may be good candidate for combination therapy with DNA damaging agents."

Clinical • Combination therapy • P1 data • Fatigue • Gynecologic Cancers • Hematological Disorders • Oncology • Ovarian Cancer • Thrombocytopenia

[VIRTUAL] ESP.01 - Updates on the Treatment of Patients with Unresectable or Metastatic HER2+ Breast Cancer who Previously Received Anti-HER2 Therapies (AACR 2021) - No abstract available

Clinical • Breast Cancer • HER2 Breast Cancer • Oncology • Solid Tumor

[VIRTUAL] ESP.01 - Daiichi Sankyo: Updates on the Treatment of Patients with Unresectable or Metastatic HER2+ Breast Cancer who Previously Received Anti-HER2 Therapies (AACR 2021) - No abstract available

Clinical • Breast Cancer • HER2 Breast Cancer • Oncology • Solid Tumor

An open-label, adaptive randomized, controlled multicenter study to evaluate the efficacy and safety of RESP301+SOC vs SOC in hospitalized participants with COVID-19 requiring supplemental oxygen (clinicaltrialsregister.eu) - P2/3; N=300; Ongoing; Sponsor: Thirty Respiratory Limited

Clinical • New P2/3 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Study of LY2880070 in Participants With Advanced or Metastatic Cancer (clinicaltrials.gov) - P1b/2a; N=185; Recruiting; Sponsor: Esperas Pharma Inc.; Active, not recruiting ➔ Recruiting

Clinical • Combination therapy • Enrollment open • Monotherapy • Breast Cancer • Colon Cancer • Colorectal Cancer • Endometrial Cancer • Gastrointestinal Cancer • Glioblastoma • Gynecologic Cancers • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Sarcoma • Solid Tumor • Triple Negative Breast Cancer

A Study of LY2880070 in Participants With Advanced or Metastatic Cancer (clinicaltrials.gov) - P1b/2a; N=185; Active, not recruiting; Sponsor: Esperas Pharma Inc.; Recruiting ➔ Active, not recruiting

Clinical • Combination therapy • Enrollment closed • Monotherapy

A three tier rapid mass programming method. (PubMed, MethodsX) - "The Master Controller co-ordinates and distributes the code for each device to the Local Controller which then programs the target devices. In the domain of networking this allows for: •Large networks of varied protocols to be programmed quickly, since towers are programmed in parallel, additional towers don't extend programming times.•Distributed networks are possible since towers are controlled over Ethernet.•Dramatically reduced labour time and defect rates due to human error in setting up devices.•This paper presents the implementation of this method for IoT Networking research with ESP-01 Target devices."

Journal

A Study of LY2880070 in Participants With Advanced or Metastatic Cancer (clinicaltrials.gov) - P1b/2a; N=185; Recruiting; Sponsor: Esperas Pharma Inc.; Trial primary completion date: Dec 2019 ➔ Mar 2020

Clinical • Combination therapy • Monotherapy • Trial primary completion date • ER • HER2

A Study of LY2880070 in Participants With Advanced or Metastatic Cancer (clinicaltrials.gov) - P1b/2a; N=185; Recruiting; Sponsor: Esperas Pharma Inc.; Trial completion date: Dec 2020 ➔ Jun 2021

Clinical • Combination therapy • Monotherapy • Trial completion date

A Study of LY2880070 in Participants With Advanced or Metastatic Cancer (clinicaltrials.gov) - P1b/2a; N=185; Recruiting; Sponsor: Esperas Pharma Inc.; Trial primary completion date: Aug 2019 ➔ Dec 2019

Clinical • Combination therapy • Monotherapy • Trial primary completion date