QBS72S / Quadriga Biosci - LARVOL DELTA

Study Assessing QBS72S For Treating Brain Metastases (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Melanie Hayden Gephart | Trial primary completion date: Feb 2025 ➔ Aug 2025

Trial primary completion date • Breast Cancer • Lung Cancer • Oncology • Solid Tumor

A Phase IIa Study to Evaluate the Efficacy and Safety of NBQ72S (clinicaltrials.gov) - P2 | N=10 | Not yet recruiting | Sponsor: Nantong Bencao Quadriga Medical Technology Co. Ltd.

New P2 trial • Breast Cancer • Oncology • Solid Tumor

Safety lead-in results for QBS10072S in the Individual Screening Trial of Innovative Glioblastoma Therapy (INSIGhT) trial, a randomized adaptive platform trial for newly diagnosed MGMT unmethylated glioblastoma (SNO 2024) - P2 | "QBS10072S can cross the blood-brain barrier, exhibits potential for cytotoxicity with a mechanism distinct from temozolomide and has low off-target effects. QBS10072S, concurrent and adjuvant to radiation therapy, was well-tolerated in patients with newly diagnosed unmethylated MGMT glioblastoma. QBS10072S 18mg/m2 is being evaluated as a treatment arm in phase 2 testing in the ongoing INSIGhT trial."

Clinical • Brain Cancer • CNS Tumor • Fatigue • Glioblastoma • Oncology • Solid Tumor • MGMT

Safety lead-in results for QBS10072S in the Individual Screening Trial of Innovative Glioblastoma Therapy (INSIGhT) trial, a randomized adaptive platform trial for newly diagnosed MGMT unmethylated glioblastoma (SNO 2024) - P2 | "QBS10072S can cross the blood-brain barrier, exhibits potential for cytotoxicity with a mechanism distinct from temozolomide and has low off-target effects. QBS10072S, concurrent and adjuvant to radiation therapy, was well-tolerated in patients with newly diagnosed unmethylated MGMT glioblastoma. QBS10072S 18mg/m2 is being evaluated as a treatment arm in phase 2 testing in the ongoing INSIGhT trial."

Clinical • Brain Cancer • CNS Tumor • Fatigue • Glioblastoma • Oncology • Solid Tumor • MGMT

INdividualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT) (clinicaltrials.gov) - P2 | N=460 | Recruiting | Sponsor: Patrick Wen, MD | Trial completion date: Dec 2025 ➔ Apr 2027 | Trial primary completion date: Mar 2025 ➔ Feb 2027

Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • IDH1

INdividualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT) (clinicaltrials.gov) - P2 | N=460 | Recruiting | Sponsor: Patrick Wen, MD | N=250 ➔ 460

Enrollment change • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • IDH1

Study Assessing QBS72S For Treating Brain Metastases (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Melanie Hayden Gephart | Phase classification: P2a ➔ P2

Phase classification • Breast Cancer • Oncology • Solid Tumor

Successful anti-tumor effects with two novel bifunctional chemotherapeutic compounds that combine a LAT1 substrate with cytotoxic moieties in aggressive T-cell lymphomas. (PubMed, Leuk Res Rep) - "The findings demonstrated decreased survival of T-cell lymphoma lines with both compounds. Overall, the results demonstrate that LAT1 is a valuable biomarker for aggressive T-cell lymphoma counterparts and QBS10072S and QBS10096S are successful therapeutic options for these aggressive diseases."

Journal • Cutaneous T-cell Lymphoma • Dermatology • Hematological Malignancies • Leukemia • Lymphoma • Mycosis Fungoides • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • SLC7A5

INdividualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT) (clinicaltrials.gov) - P2 | N=250 | Recruiting | Sponsor: Patrick Wen, MD | Trial primary completion date: Dec 2024 ➔ Mar 2025

Trial primary completion date • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • IDH1

INdividualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT) (clinicaltrials.gov) - P2 | N=250 | Recruiting | Sponsor: Patrick Wen, MD | Active, not recruiting ➔ Recruiting | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Dec 2023 ➔ Dec 2024

Enrollment open • Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • IDH1

Quadriga BioSciences Announces Dosing of First Subject in Phase 2 Study Evaluating QBS72S For Brain Metastases of Breast Cancer (PRNewswire) - "Quadriga BioSciences...announced the dosing of the first subject in a Phase 2 study evaluating QBS72S for the treatment of brain metastases of breast cancers."

Trial status • Brain Cancer • Breast Cancer • CNS Tumor • Oncology • Solid Tumor

Quadriga BioSciences Announces Dosing of First Subject in Phase 2 Study Evaluating QBS72S For Glioblastoma (PRNewswire) - "Quadriga BioSciences...announced the dosing of the first subject with QBS72S in the Phase 2 INSIGhT study, evaluating QBS72S against the standard of care (temozolomide) for the potential treatment of newly diagnosed glioblastoma....The Phase 2 study is funded by a Small Business Innovation Grant (SBIR)."

Trial status • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

Study Assessing QBS72S For Treating Brain Metastases of Breast Cancer (clinicaltrials.gov) - P2a | N=40 | Recruiting | Sponsor: Melanie Hayden Gephart | Trial completion date: Oct 2025 ➔ Aug 2026 | Trial primary completion date: Apr 2024 ➔ Feb 2025

Trial completion date • Trial primary completion date • Breast Cancer • Oncology • Solid Tumor

Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of QBS10072S (clinicaltrials.gov) - P1 | N=15 | Completed | Sponsor: Quadriga Biosciences, Inc. | Active, not recruiting ➔ Completed | N=50 ➔ 15

Enrollment change • Metastases • Trial completion • Anaplastic Astrocytoma • Astrocytoma • Biliary Cancer • Bladder Cancer • Brain Cancer • Breast Cancer • Cervical Cancer • Cholangiocarcinoma • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Glioblastoma • Head and Neck Cancer • Hepatology • Kidney Cancer • Liver Cancer • Lung Cancer • Malignant Pleural Mesothelioma • Melanoma • Mesothelioma • Oncology • Oral Cancer • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Renal Cell Carcinoma • Sarcoma • Solid Tumor • Thymic Carcinoma • Thymus Cancer • Tongue Carcinoma • Urothelial Cancer

Quadriga BioSciences Announces Completion of Enrollment in Phase 1 Study of QBS72S for Solid Tumors (PRNewswire) - "Quadriga BioSciences...announced the completion of enrollment for a Phase 1 dose escalation study investigating QBS72S in patients with advanced or metastatic solid cancers....'With the study complete, Quadriga is able to launch two Phase 2 studies investigating QBS72S for brain malignancies, each of which is supported by funding from an SBIR grant'....The Phase 1, multi-center, open-label, dose-escalation study [NCT04430842] was designed to evaluate the safety and tolerability of QBS72S in patients with advanced or metastatic solid tumors. Results of the Phase 1 study have informed the recommended Phase 2 dose (RP2D) for two imminent Phase 2 studies: one investigating QBS72S for the potential treatment of brain metastases of triple negative breast cancer at Stanford University [NCT05305365] and one investigating QBS72S for the potential treatment of glioblastoma at the Dana-Farber Cancer Institute [NCT02977780]....The studies are expected to launch in Q4'2022."

Enrollment closed • Trial status • Astrocytoma • Biliary Tract Cancer • Bladder Cancer • Brain Cancer • Breast Cancer • Cervical Cancer • Cholangiocarcinoma • CNS Tumor • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Glioblastoma • Gynecologic Cancers • Head and Neck Cancer • Hepatocellular Cancer • Kidney Cancer • Liver Cancer • Lung Cancer • Malignant Pleural Mesothelioma • Melanoma • Mesothelioma • Oncology • Oral Cancer • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Sarcoma • Skin Cancer • Solid Tumor • Thymic Carcinoma • Thymus Cancer • Tongue Carcinoma

Study Assessing QBS72S For Treating Brain Metastases of Triple Negative Breast Cancer (clinicaltrials.gov) - P2a | N=35 | Recruiting | Sponsor: Melanie Hayden Gephart | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PGR

Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of QBS10072S (clinicaltrials.gov) - P1 | N=50 | Active, not recruiting | Sponsor: Quadriga Biosciences, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Anaplastic Astrocytoma • Astrocytoma • Biliary Cancer • Bladder Cancer • Brain Cancer • Breast Cancer • Cervical Cancer • Cholangiocarcinoma • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Glioblastoma • Head and Neck Cancer • Hepatology • Kidney Cancer • Liver Cancer • Lung Cancer • Malignant Pleural Mesothelioma • Melanoma • Mesothelioma • Oncology • Oral Cancer • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Renal Cell Carcinoma • Sarcoma • Solid Tumor • Thymic Carcinoma • Thymus Cancer • Tongue Carcinoma • Urothelial Cancer

Study Assessing QBS72S For Treating Brain Metastases of Triple Negative Breast Cancer (clinicaltrials.gov) - P2a | N=35 | Not yet recruiting | Sponsor: Melanie Hayden Gephart | Initiation date: Apr 2022 ➔ Jul 2022

Trial initiation date • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PGR

Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of QBS10072S (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: Quadriga Biosciences, Inc. | Trial completion date: Dec 2021 ➔ Dec 2022 | Trial primary completion date: Sep 2021 ➔ Sep 2022

Trial completion date • Trial primary completion date • Anaplastic Astrocytoma • Astrocytoma • Biliary Cancer • Bladder Cancer • Brain Cancer • Breast Cancer • Cervical Cancer • Cholangiocarcinoma • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Glioblastoma • Head and Neck Cancer • Hepatology • Kidney Cancer • Liver Cancer • Lung Cancer • Malignant Pleural Mesothelioma • Melanoma • Mesothelioma • Oncology • Oral Cancer • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Renal Cell Carcinoma • Sarcoma • Solid Tumor • Thymic Carcinoma • Thymus Cancer • Tongue Carcinoma • Urothelial Cancer

Study Assessing QBS72S For Treating Brain Metastases of Triple Negative Breast Cancer (clinicaltrials.gov) - P2a | N=35 | Not yet recruiting | Sponsor: Melanie Hayden Gephart

New P2a trial • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PGR

A Novel Blood-Brain Barrier-Permeable Chemotherapeutic Agent for the Treatment of Glioblastoma. (PubMed, Cureus) - "Introduction The standard treatment for glioblastoma (GBM) patients is surgical tumor resection, followed by radiation and chemotherapy with temozolomide (TMZ). In orthotopic GBM xenografts, QBS10072S treatment significantly delayed tumorigenesis and prolonged animal survival compared to the vehicle without adverse effects. Conclusion QBS10072S is a novel BBB-permeable chemotherapeutic agent with the potential to treat TMZ-resistant and recurrent GBM as monotherapy or in combination with radiation treatment."

Journal • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • MGMT

A Novel Brain-Permeant Chemotherapeutic Agent for the Treatment of Brain Metastasis in Triple-Negative Breast Cancer. (PubMed, Mol Cancer Ther) - "Treatment options for TNBC leptomeningeal metastasis are limited and are mostly palliative. Our study demonstrates significant efficacy of the brain-penetrating agent QBS10072S against TNBC brain metastasis and leptomeningeal spread."

Journal • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of QBS10072S (clinicaltrials.gov) - P1; N=50; Recruiting; Sponsor: Quadriga Biosciences, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Astrocytoma • Biliary Cancer • Bladder Cancer • Brain Cancer • Breast Cancer • Cervical Cancer • Cholangiocarcinoma • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Glioblastoma • Gynecologic Cancers • Head and Neck Cancer • Liver Cancer • Lung Cancer • Melanoma • Mesothelioma • Oncology • Oral Cancer • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Renal Cell Carcinoma • Sarcoma • Solid Tumor • Thoracic Cancer • Thymus Cancer • Tongue Carcinoma • Urothelial Cancer

Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of QBS10072S (clinicaltrials.gov) - P1; N=50; Not yet recruiting; Sponsor: Quadriga Biosciences, Inc.

Clinical • New P1 trial • Astrocytoma • Biliary Cancer • Bladder Cancer • Brain Cancer • Breast Cancer • Cervical Cancer • Cholangiocarcinoma • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Glioblastoma • Gynecologic Cancers • Head and Neck Cancer • Hepatocellular Cancer • Liver Cancer • Lung Cancer • Melanoma • Mesothelioma • Oncology • Oral Cancer • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Renal Cell Carcinoma • Sarcoma • Solid Tumor • Thoracic Cancer • Thymus Cancer • Tongue Carcinoma • Urothelial Cancer