Peter MacCallum Cancer Centre Protocol No. PMCC 12/79
Estimated Enrollment
37 evaluable subjects
Objective
Primary endpoint
To determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of intravenously administered CX-5461 when used intravenously in Haematologic Malignacies.
Secondary endpoint
To establish the safety profile of CX-5461 at the MTD.
To establish the pharmacokinetic (PK) profile of CX-5461.
To observe patients for evidence of CX-5461 biological activity using pharmacodynamic (PD) assessments.
To observe patients for preliminary antitumor activity of CX-5461.
To evaluate the mechanism of action of CX-5461 in haematologic cancers.
To identify predictive biomarkers of efficacy in human haematologic cancers.
Senhwa Biosciences, Inc. Stand Up To Cancer (SU2C) Canada - Canadian Breast Cancer Foundation Grant
Estimated Enrollment
40-60 patients with solid tumors for Dose Escalation stage. 10-20 patients with metastatic breast cancer for Expansion stage
Objective
Phase I Escalation (Solid tumors)
Primary Objective:
To determine the recommended phase II dose (RP2D) and schedule of CX-5461 in patients with solid tumors.
Secondary Objective:
To establish the safety and tolerability of CX-5461 given intravenously to patients with solid tumors.
To determine the pharmacokinetics of CX-5461 given intravenously in patients with solid tumors.
Phase I Expansion: (Breast cancer)
Primary Objective:
To explore the relationship between germline HRD (homologous recombination deficiency) aberrations and outcomes of CX-5461, including efficacy and toxicity.
To evaluate CX-5461 drug levels in skin and tumor.
To evaluate biomarkers of response to CX-5461
using ctDNA (all patients after Amendment #3);
paired biopsies (all patients after Amendment #3);
paired tumour biopsies (mandatory for 6-8 patients at RP2D)
CX-5461-Solid Tumors and BRCA2 and/or PALB2 mutation
Study Focus
CX-5461-Solid Tumors and BRCA2 and/or PALB2 mutation
Protocol Number
CX-5461-04
Sponsor
Senhwa Biosciences, Inc.
Estimated Enrollment
52 patients • Main study - 32 patients • Exploratory study -20 patients
Objective
Primary Objective:
To determine the recommended phase II dose (RP2D)
Secondary Objective:
To assess the safety and tolerability, e.g. late onset toxicity (ocular toxicity)
To evaluate the anti-tumour activity in patients with solid tumours and germline BRCA2 and/or PALB2
To evaluate the effect on Health Related Quality of Life (HRQoL) - using Patient Reported Outcomes
Exploratory Objective:
To evaluate the anti-tumour activity of CX-5461 in patients with ovarian cancer and pathogenic/likely pathogenic BRCA1 mutation and/or other HRD-associated somatic mutation.
To characterize the molecular profile of tumours and evaluate predictive value of mutational signatures (including BRCA 1/ 2, PALB2, and other HRD-associated somatic mutations) in predicting response or resistance to CX-5461.
To explore the significance of dynamic changes in ctDNA levels and plasma DNA
CX-5461/Talazoparib-Metastatic Castration Resistant Prostate Cancer
Study Focus
CX-5461/Talazoparib-Metastatic Castration Resistant Prostate Cancer
Protocol Number
20/019
Sponsor
Peter MacCallum Cancer Centre
Requestor
Peter MacCallum Cancer Centre
Estimated Enrollment
48
Objective
Primary Objective:
To establish the maximum tolerated dose (MTD), dose limiting toxicities (DLTs) and recommended phase 2 dose (RP2D) of pidnarulex in combination with talazoparib in patients with metastatic castration resistant prostate cancer (mCRPC).
Secondary Objectives:
To evaluate the safety of pidnarulex in combination with talazoparib in patients with mCRPC
To evaluate the anti-tumour activity of pidnarulex in combination with talazoparib in patients with mCRPC by the following assessments: To evaluate the rate of treatment discontinuation due to toxicity
50% prostate specific antigen (PSA) response rate (PSA-RR)
Radiographic progression-free survival (rPFS)
PSA progression free survival (PSA-PFS)
Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 in patients with measurable disease
Overall survival (OS)
Duration of response (DOR)
Time to treatment response (TTR) in the subset of patients who achieved a 50% PSA response
To evaluate the rate of treatment discontinuation due to toxicity