YL-13027 / Shanghai YingLi Pharma - LARVOL DELTA

A Trial of YL-13027 in Combination With Gemcitabine and Nab-paclitaxel in Patients With Refractory Metastatic Pancreatic Cancer (clinicaltrials.gov) - P1 | N=4 | Terminated | Sponsor: M.D. Anderson Cancer Center | N=64 ➔ 4 | Trial completion date: Jan 2027 ➔ Sep 2025 | Active, not recruiting ➔ Terminated | Trial primary completion date: Jan 2027 ➔ Sep 2025; <75 % participation

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Oncology • Pancreatic Cancer • Solid Tumor

YL-13027 and/or HY-0102 Combined With AG Regimen Chemotherapy for Metastatic Pancreatic Cancer (clinicaltrials.gov) - P1/2 | N=120 | Not yet recruiting | Sponsor: Shanghai YingLi Pharmaceutical Co. Ltd.

Metastases • New P1/2 trial • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor

A Trial of YL-13027 in Combination With Gemcitabine and Nab-paclitaxel in Patients With Refractory Metastatic Pancreatic Cancer (clinicaltrials.gov) - P1 | N=64 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Metastases • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor

A Trial of YL-13027 in Combination With Gemcitabine and Nab-paclitaxel in Patients With Refractory Metastatic Pancreatic Cancer (clinicaltrials.gov) - P1 | N=64 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Not yet recruiting ➔ Recruiting | Initiation date: Jun 2024 ➔ Jan 2024

Combination therapy • Enrollment open • Metastases • Trial initiation date • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor

A Trial of YL-13027 in Combination With Gemcitabine and Nab-paclitaxel in Patients With Refractory Metastatic Pancreatic Cancer (clinicaltrials.gov) - P1 | N=64 | Not yet recruiting | Sponsor: M.D. Anderson Cancer Center

Combination therapy • Metastases • New P1 trial • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor

A Phase 1b/2 Study of YL-13027 Combined With Sintilimab in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1b/2 | N=49 | Recruiting | Sponsor: Shanghai YingLi Pharmaceutical Co. Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Ependymoma • Head and Neck Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Single-cell transcriptome reveals cellular hierarchies and guides p-EMT-targeted trial in skull base chordoma. (PubMed, Cell Discov) - "Encouragingly, YL-13027 attenuated the growth of SBC and achieved stable disease with no serious adverse events, underscoring the clinical potential for the precision treatment of SBC with this therapy. In summary, we conducted the first single-cell RNA sequencing of SBC and identified several targets that could be translated to the treatment of SBC."

Journal • Chordoma • Oncology • Osteosarcoma • Sarcoma • Solid Tumor • CTSL • TGFB1

Yingli Pharma Doses First US Patient in Phase 1 Study of YL-13027 for Patients with Advanced Solid Tumors (GlobeNewswire) - "Yingli Pharma US, Inc...announced that the first patient has been dosed in its Phase 1 clinical study evaluating YL-13027, a potent and selective TGFβ receptor 1 (TGFβR1) inhibitor. The dose-finding exploratory trial in patients with advanced solid tumors is being conducted in collaboration with The University of Texas MD Anderson Cancer Center and 4 clinical centers in the U.S....A dose expansion phase is planned to further evaluate the safety, tolerability and anti-tumor activity of the TGFβR1 inhibitor at the recommended Phase 2 dose....The study has an estimated enrollment of 54 participants."

Trial status • Oncology • Solid Tumor

YL-13027 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=54 | Recruiting | Sponsor: Shanghai YingLi Pharmaceutical Co. Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor • PD-L1

YL-13027 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=54 | Not yet recruiting | Sponsor: Shanghai YingLi Pharmaceutical Co. Ltd.

New P1 trial • Oncology • Solid Tumor • PD-L1

Yingli Pharma and MD Anderson Initiate Strategic Collaboration to Advance Development of Multiple Oncology Programs (GlobeNewswire) - "Two of the programs supported by the collaboration will leverage favorable clinical trial findings collected from China-based studies. The first program will focus on linperlisib, a PI3Kδ inhibitor with a novel structure, which has had positive results in eight active or completed Phase 1 and Phase 2 clinical trials for patients with lymphomas and solid tumors, including peripheral T cell lymphoma (PTCL)...The second program will develop YL-13027, a novel, oral TGFβR1 inhibitor for use in advanced solid tumors with plans to initiate a U.S.-based Phase 1 clinical trial in 2022..."

Licensing / partnership • New P1 trial • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • Solid Tumor

First in Human Dose Escalation Study of YL-13027 in Subjects With Advanced Stage Solid Tumors (clinicaltrials.gov) - P1; N=36; Recruiting; Sponsor: Shanghai YingLi Pharmaceutical Co. Ltd.; N=24 ➔ 36; Trial completion date: Mar 2020 ➔ Jun 2022; Trial primary completion date: Mar 2020 ➔ Apr 2021

Clinical • Enrollment change • Monotherapy • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

[VIRTUAL] A phase I study of a TGF-β receptor I kinase inhibitor YL-13027 in patients with advanced solid tumors. (ASCO 2021) - P1 | "YL-13027 is well tolerated and further clinical investigation is warranted."

Clinical • IO biomarker • P1 data • Breast Cancer • Cardiovascular • Gastrointestinal Disorder • Oncology • Solid Tumor • Triple Negative Breast Cancer • TGFB1

Yingli Pharma Announces presentations on the Phase 1 trials of linperlisib, a PI3Kδ selective inhibitor, and YL-13027, an oral TGFβR1 inhibitor, at the American Society for Clinical Oncology 2021 Annual Meeting (PRNewswire) - "Shanghai Yingli Pharmaceuticals...announced today that there will be three presentations on clinical trials sponsored by the company at the annual meeting of the American Society for Clinical Oncology (ASCO) June 4-7, 2021...Top line data from this study indicated that for the 38 r/r PTCL patients enrolled, 30 were evaluable. As of the data cutoff, an Overall Response Rate (ORR) of 70% was reported of which 33% were complete responses...The results of this Phase 1b clinical trial suggest that linperlisib is a promising PI3Kδ selective inhibitor with important anti-tumor properties in this indication, and we hope it will be able to bring clinical benefits of linerlisib to patients suffering from this serious disease."

P1 data • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • Solid Tumor