taragarestrant (D-0502) / InventisBio - LARVOL DELTA

A Study to Evaluate D-0502 in Subjects With ER+ Her2- Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov) - P3 | N=640 | Recruiting | Sponsor: InventisBio Co., Ltd

New P3 trial • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

A First-in-Human Study of D-0502 Alone and in Combination With Palbociclib in Women With Advanced or Metastatic ER-Positive and HER2-Negative Breast Cancer (clinicaltrials.gov) - P1 | N=200 | Completed | Sponsor: InventisBio Co., Ltd | Active, not recruiting ➔ Completed | Trial primary completion date: Oct 2021 ➔ Oct 2023

Combination therapy • Metastases • Trial completion • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

A Phase Ⅰb Study of D-0502 as Monotherapy for Advanced or Metastatic ER-Positive and HER2-Negative Breast Cancer: Results from the Dose-Expansion Stage (SABCS 2023) - P1 | "The phase Ⅰ open-label study (NCT03471663) evaluated the safety, tolerability, pharmacokinetics (PK) and efficacy of D-0502 as monotherapy and in combination with palbociclib in female patients with ER+ and HER2- breast cancer. D-0502 monotherapy showed promising antitumor activity and tolerable toxicity in female patients with ER+ and HER2- locally advanced or metastatic BC. Currently this treatment is being evaluated in a phase Ⅲ study for patients with ER+ and HER2- locally advanced or metastatic BC in China."

Metastases • Monotherapy • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Study in Healthy Adult Female Subjects (clinicaltrials.gov) - P1 | N=8 | Completed | Sponsor: InventisBio Co., Ltd | Active, not recruiting ➔ Completed

Trial completion

Evaluation of Relative Bioavailability of D-0502 Tablet in Healthy Female Subjects (clinicaltrials.gov) - P1 | N=18 | Completed | Sponsor: InventisBio Co., Ltd | Active, not recruiting ➔ Completed

Trial completion

Study in Healthy Adult Female Subjects (clinicaltrials.gov) - P1 | N=8 | Active, not recruiting | Sponsor: InventisBio Co., Ltd | Trial primary completion date: May 2022 ➔ Aug 2022

Trial primary completion date

Evaluation of Relative Bioavailability of D-0502 Tablet in Healthy Female Subjects (clinicaltrials.gov) - P1 | N=18 | Active, not recruiting | Sponsor: InventisBio Co., Ltd | Trial completion date: Apr 2022 ➔ Jul 2022

Trial completion date

A First-in-Human Study of D-0502 Alone and in Combination With Palbociclib in Women With Advanced or Metastatic ER-Positive and HER2-Negative Breast Cancer (clinicaltrials.gov) - P1 | N=200 | Active, not recruiting | Sponsor: InventisBio Co., Ltd | Recruiting ➔ Active, not recruiting | N=57 ➔ 200 | Trial completion date: Dec 2022 ➔ Jul 2023

Combination therapy • Enrollment change • Enrollment closed • Trial completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Study in Healthy Adult Female Subjects (clinicaltrials.gov) - P1 | N=8 | Active, not recruiting | Sponsor: InventisBio Co., Ltd | Recruiting ➔ Active, not recruiting

Enrollment closed

Study in Healthy Adult Female Subjects (clinicaltrials.gov) - P1 | N=8 | Recruiting | Sponsor: InventisBio Co., Ltd

New P1 trial

Evaluation of Relative Bioavailability of D-0502 Tablet in Healthy Female Subjects (clinicaltrials.gov) - P1 | N=18 | Active, not recruiting | Sponsor: InventisBio Co., Ltd

New P1 trial

[VIRTUAL] A phase 1 study of D-0502, an orally bioavailable SERD, for advanced or metastatic HR-positive and HER2-negative breast cancer (SABCS 2020) - P1 | "Fulvestrant is currently the only approved agent in its class and is limited by poor oral bioavailability necessitating monthly intramuscular injections...In Stage 1, D-0502 was evaluated with palbociclib at a dose below the MTD first before escalating to the MTD... A first-in-human phase 1 study of D-0502 has been initiated in women with advanced or metastatic HR-positive and HER2-negative breast cancer. D-0502 has been well tolerated and achieved significant exposure and preliminary clinical activity in patients. Further results will be presented at the meeting."

P1 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

A First-in-Human Study of D-0502 Alone and in Combination With Palbociclib in Women With Advanced or Metastatic ER-Positive and HER2-Negative Breast Cancer (clinicaltrials.gov) - P1; N=57; Recruiting; Sponsor: InventisBio Inc.; Trial completion date: Oct 2021 ➔ Dec 2022; Trial primary completion date: Apr 2021 ➔ Dec 2021

Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

InventisBio Announces $147 Million Series D Financing Led by Hillhouse Affiliate GL Ventures (PRNewswire) - "InventisBio...announced the recent completion of a $147 million series D financing which has attracted participation of many top biopharmaceutical and healthcare venture capital funds...Funds raised in this round will be mainly used to support the company's current products into phase II clinical studies in China and the United States, including D-0502 trials in hormone receptor positive breast cancer and D-0120 trials in gout."

Financing • Breast Cancer • Oncology