rilunermin alfa (SCB-313) / Sichuan Clover Biopharma - LARVOL DELTA

A Phase I Study Evaluating SCB-313 for the Treatment of Subjects With Peritoneal Carcinomatosis (clinicaltrials.gov) - P1 | N=10 | Terminated | Sponsor: Sichuan Clover Biopharmaceuticals, Inc. | N=20 ➔ 10 | Recruiting ➔ Terminated | Trial primary completion date: Feb 2022 ➔ May 2022; terminated

Enrollment change • Trial primary completion date • Trial termination • Oncology • Peritoneal Cancer

First-in-human (FIH) phase I studies of SCB-313, a novel TNF-related apoptosis-inducing ligand TRAIL-Trimer™ fusion protein, for treatment of patients (pts) with malignant ascites (MA) (AACR 2022) - P1 | "Although the MTD was not defined by these studies, SCB-313 therapy presents an acceptable safety profile at all tested dose levels. Measurable ascites flow rate decrease were observed at all dose- levels. These data support further development of SCB-313 for pts with MA."

Clinical • P1 data • Breast Cancer • Colon Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Ovarian Cancer • Solid Tumor

Study With SCB-313 (Recombinant Human TRAIL-Trimer Fusion Protein) for Treatment of Malignant Ascites (clinicaltrials.gov) - P1 | N=13 | Completed | Sponsor: Sichuan Clover Biopharmaceuticals, Inc. | Active, not recruiting ➔ Completed

Trial completion • Solid Tumor

A Phase I Study Evaluating SCB-313(Recombinant Human TRAIL-Trimer Fusion Protein) for the Treatment of Malignant Pleural Effusion (clinicaltrials.gov) - P1 | N=14 | Completed | Sponsor: Sichuan Clover Biopharmaceuticals, Inc. | Active, not recruiting ➔ Completed | N=25 ➔ 14

Enrollment change • Trial completion • Oncology • Respiratory Diseases

Study With SCB-313 (Recombinant Human TRAIL-Trimer Fusion Protein) for Treatment of Malignant Pleural Effusions (clinicaltrials.gov) - P1 | N=5 | Completed | Sponsor: Clover Biopharmaceuticals AUS Pty Ltd | Active, not recruiting ➔ Completed | Trial completion date: Mar 2022 ➔ Nov 2021

IO biomarker • Trial completion • Trial completion date • Respiratory Diseases • BCL2 • CEACAM5 • KRAS • MUC16

Study With SCB-313 (Recombinant Human TRAIL-Trimer Fusion Protein) for Treatment of Malignant Ascites (clinicaltrials.gov) - P1; N=13; Active, not recruiting; Sponsor: Sichuan Clover Biopharmaceuticals, Inc.; Recruiting ➔ Active, not recruiting; N=30 ➔ 13

Clinical • Enrollment change • Enrollment closed • Solid Tumor

Clover and Ascentage Pharma Announce Clinical Collaboration to Evaluate Recombinant Human TRAIL-Trimer Fusion Protein, SCB-313, in Combination with IAP Antagonist, APG-1387 for the Treatment of Peritoneal Carcinomatosis (GlobeNewswire) - "Clover Biopharmaceuticals, Ltd...and Ascentage Pharma....announced that they have entered into a clinical collaboration to evaluate Clover’s SCB-313, a recombinant human TRAIL-Trimer fusion protein and Ascentage Pharma’s APG-1387....Based on positive Phase 1 interim analyses, Clover plans to advance SCB-313 into a Phase 2 clinical trial for malignant ascities in the first half of 2022....Clover also plans to initiate new Phase 1 trials for SCB-313 in new indications, such as bladder cancer, in 2022."

Licensing / partnership • New P1 trial • New P2 trial • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

A Phase I Study Evaluating SCB-313 for the Treatment of Subjects With Peritoneal Carcinomatosis (clinicaltrials.gov) - P1; N=20; Recruiting; Sponsor: Sichuan Clover Biopharmaceuticals, Inc.; Trial completion date: Dec 2021 ➔ May 2022; Trial primary completion date: Sep 2021 ➔ Feb 2022

Clinical • Trial completion date • Trial primary completion date • Oncology • Peritoneal Cancer

A Phase I Study Evaluating SCB-313(Recombinant Human TRAIL-Trimer Fusion Protein) for the Treatment of Malignant Pleural Effusion (clinicaltrials.gov) - P1; N=25; Active, not recruiting; Sponsor: Sichuan Clover Biopharmaceuticals, Inc.; Recruiting ➔ Active, not recruiting; N=12 ➔ 25

Clinical • Enrollment change • Enrollment closed • Oncology • Respiratory Diseases

Study With SCB-313 (Recombinant Human TRAIL-Trimer Fusion Protein) for Treatment of Malignant Pleural Effusions (clinicaltrials.gov) - P1; N=5; Active, not recruiting; Sponsor: Clover Biopharmaceuticals AUS Pty Ltd; Recruiting ➔ Active, not recruiting; N=16 ➔ 5; Trial completion date: Dec 2021 ➔ Mar 2022

Clinical • Enrollment change • Enrollment closed • IO biomarker • Trial completion date • Respiratory Diseases • BCL2 • CEACAM5 • KRAS • MUC16

Study With SCB-313 (Recombinant Human TRAIL-Trimer Fusion Protein) for Treatment of Malignant Ascites (clinicaltrials.gov) - P1; N=30; Recruiting; Sponsor: Sichuan Clover Biopharmaceuticals, Inc.; Trial completion date: Jun 2021 ➔ Mar 2022; Trial primary completion date: Mar 2021 ➔ Jan 2022

Clinical • Trial completion date • Trial primary completion date • Solid Tumor

Study With SCB-313 (Recombinant Human TRAIL-Trimer Fusion Protein) for Treatment of Peritoneal Malignancies (clinicaltrials.gov) - P1; N=7; Completed; Sponsor: Clover Biopharmaceuticals AUS Pty Ltd; Recruiting ➔ Completed; N=12 ➔ 7; Trial completion date: Dec 2021 ➔ Aug 2021; Trial primary completion date: Sep 2021 ➔ May 2021

Clinical • Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Oncology

A Phase I Study Evaluating SCB-313(Recombinant Human TRAIL-Trimer Fusion Protein) for the Treatment of Malignant Pleural Effusion (clinicaltrials.gov) - P1; N=12; Recruiting; Sponsor: Sichuan Clover Biopharmaceuticals, Inc.; Trial completion date: Apr 2021 ➔ Dec 2021; Trial primary completion date: Dec 2020 ➔ Aug 2021

Clinical • Trial completion date • Trial primary completion date • Oncology • Respiratory Diseases

Study With SCB-313 (Recombinant Human TRAIL-Trimer Fusion Protein) for Treatment of Peritoneal Malignancies (clinicaltrials.gov) - P1; N=12; Recruiting; Sponsor: Clover Biopharmaceuticals AUS Pty Ltd; Trial completion date: Dec 2020 ➔ Dec 2021; Trial primary completion date: Nov 2020 ➔ Sep 2021

Clinical • Trial completion date • Trial primary completion date • Oncology

Study With SCB-313 (Recombinant Human TRAIL-Trimer Fusion Protein) for Treatment of Malignant Pleural Effusions (clinicaltrials.gov) - P1; N=16; Recruiting; Sponsor: Clover Biopharmaceuticals AUS Pty Ltd; Trial completion date: Dec 2020 ➔ Dec 2021; Trial primary completion date: Nov 2020 ➔ Sep 2021

Clinical • IO biomarker • Trial completion date • Trial primary completion date • Respiratory Diseases • BCL2 • CEACAM5 • KRAS • MUC16

Study With SCB-313 (Recombinant Human TRAIL-Trimer Fusion Protein) for Treatment of Malignant Ascites (clinicaltrials.gov) - P1; N=30; Recruiting; Sponsor: Sichuan Clover Biopharmaceuticals, Inc.; Trial completion date: Dec 2020 ➔ Jun 2021; Trial primary completion date: Dec 2020 ➔ Mar 2021

Clinical • Trial completion date • Trial primary completion date • Solid Tumor

A Phase I Study Evaluating SCB-313 for the Treatment of Subjects With Peritoneal Carcinomatosis (clinicaltrials.gov) - P1; N=20; Recruiting; Sponsor: Sichuan Clover Biopharmaceuticals, Inc.; Trial completion date: May 2021 ➔ Dec 2021; Trial primary completion date: May 2021 ➔ Sep 2021

Clinical • Trial completion date • Trial primary completion date • Oncology • Peritoneal Cancer

Study With SCB-313 (Recombinant Human TRAIL-Trimer Fusion Protein) for Treatment of Peritoneal Malignancies (clinicaltrials.gov) - P1; N=12; Recruiting; Sponsor: Clover Biopharmaceuticals AUS Pty Ltd; N=18 ➔ 12; Trial completion date: Aug 2019 ➔ Dec 2020; Trial primary completion date: Aug 2019 ➔ Nov 2020

Clinical • Enrollment change • Trial completion date • Trial primary completion date

Study With SCB-313 (Recombinant Human TRAIL-Trimer Fusion Protein) for Treatment of Malignant Pleural Effusions (clinicaltrials.gov) - P1; N=16; Recruiting; Sponsor: Clover Biopharmaceuticals AUS Pty Ltd; Trial completion date: Feb 2020 ➔ Dec 2020; Trial primary completion date: Feb 2020 ➔ Nov 2020

Clinical • IO Biomarker • Trial completion date • Trial primary completion date • BCL2 • CA125 • KRAS

A Phase I Study Evaluating SCB-313(Recombinant Human TRAIL-Trimer Fusion Protein) for the Treatment of Malignant Pleural Effusion (clinicaltrials.gov) - P1; N=12; Recruiting; Sponsor: Sichuan Clover Biopharmaceuticals, Inc.; Not yet recruiting ➔ Recruiting

Enrollment open

Clover Biopharmaceuticals doses first patient in phase I study of SCB-313 in China for malignant pleural effusions (MPE) (Businesswire) - "Clover Biopharmaceuticals...announced that the first patient was dosed in another Phase I trial of SCB-313, an investigational fully-human TRAIL-Trimer fusion protein, in China for the treatment of cancer patients with malignant pleural effusions (MPE)."

Enrollment open

Clover Biopharmaceuticals doses first patient in phase I study of SCB-313 in Australia for malignant pleural effusions (MPE) (Businesswire) - "Clover Biopharmaceuticals....announced that the first patient was dosed in a Phase I trial of SCB-313, an investigational fully-human TRAIL-Trimer fusion protein, in Australia for the treatment of cancer patients with malignant pleural effusions (MPE). There are now five clinical studies evaluating SCB-313 open to recruiting patients in China and Australia across three oncology indications (malignant ascites, peritoneal carcinomatosis, and malignant pleural effusions)."

Trial status

Study With SCB-313 (Recombinant Human TRAIL-Trimer Fusion Protein) for Treatment of Malignant Pleural Effusions (clinicaltrials.gov) - P1; N=16; Recruiting; Sponsor: Clover Biopharmaceuticals AUS Pty Ltd; Initiation date: Mar 2019 ➔ Aug 2019

Clinical • IO Biomarker • Trial initiation date

Study With SCB-313 (Recombinant Human TRAIL-Trimer Fusion Protein) for Treatment of Malignant Pleural Effusions (clinicaltrials.gov) - P1; N=16; Recruiting; Sponsor: Clover Biopharmaceuticals AUS Pty Ltd

Clinical • IO Biomarker • New P1 trial

A Phase I Study Evaluating SCB-313(Recombinant Human TRAIL-Trimer Fusion Protein) for the Treatment of Malignant Pleural Effusion (clinicaltrials.gov) - P1; N=12; Not yet recruiting; Sponsor: Sichuan Clover Biopharmaceuticals, Inc.

Clinical • New P1 trial