An Open-Label Study of Intravenous BAL101553 in Adult Patients With Solid Tumors

An Open-Label Phase I/IIa Study of Intravenous BAL101553 in Adult Patients With Advanced Solid Tumors

First in human, open-label, sequential dose escalation and expansion study of intravenous BAL101553 in adult patients with advanced solid tumors.

Study Overview

• Status: Completed
• Conditions: Solid Organ Tumors
• Intervention / Treatment: Drug: BAL101553

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, WC1E 2PG
    • University College London NHS Foundation Trust
  • Newcastle upon Tyne, United Kingdom, NE7 7DN
    • Sir Bobby Robson Cancer Trials Research Centre; Northern Centre for Cancer Care
  • Surrey
    • Sutton, Surrey, United Kingdom, SM2 5PT
      • Royal Marsden Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 18 years
2. Patients with one of the following advanced or recurrent solid tumor types, who failed standard therapy or for whom no effective standard therapy is available:colorectal; gastric or cancers of the gastro-esophageal junction; non-small cell lung cancer; ovarian (or primary peritoneal); pancreatic (including ampullary); triple-negative breast
3. Measurable tumor disease (or non-measurable ovarian cancer that can be followed by CA-125)
4. Life expectancy ≥ 12 weeks
5. Acceptable organ and marrow function at baseline (protocol defined laboratory parameters)
6. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
7. Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

1. Patients who have received chemotherapy, radiotherapy, immunotherapy, or investigational agents within 4 weeks prior to starting study drug or who have not recovered from side effects of prior therapies
2. Symptomatic brain metastases (including leptomeningeal disease) indicative of active disease
3. Peripheral neuropathy ≥ CTCAE v4 grade 2
4. Uncontrolled intercurrent illness that would unduly increase the risk of toxicity or limit compliance with study requirements
5. Women who are pregnant or breast-feeding. Men or women of reproductive potential who are not willing to apply effective birth control
6. Systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg observed as part of the screening examination.
7. Patients treated with a calcium channel blocker or who require combination of more than 2 antihypertensives to control blood pressure.
8. Other protocol-defined exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Drug: BAL101553 at MTD	Drug: BAL101553; Intravenous administration
Experimental: Drug: BAL101553 at 50% of MTD	Drug: BAL101553; Intravenous administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine the maximum tolerated dose and characterize dose limiting toxicities of BAL101553	First-cycle dose limiting toxicities (DLT)	28 day cycles

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate safety and tolerability of BAL101553 treatment	Incidence of adverse events, laboratory abnormalities, clinically significant changes in vital signs or ECG assessments	28 day cycles
To evaluate BAL101553 pharmacokinetics	BAL101553 and BAL27862 PK parameters including (but not limited to): Cmax (maximum observed plasma concentration), AUC (area under the concentration time curve), half-life, volume of distribution	28 day cycles
To assess anti-tumor activity of BAL101553	Response rate per RECIST guidelines	28 day cycles
To explore the use of biomarkers and to characterize pharmacodynamic effects of BAL101553	Exploratory assessment of baseline levels and change from baseline in the number of circulating tumor cells and other biomarkers	28 day cycles

Collaborators and Investigators

• Sponsor: Basilea Pharmaceutica
• Investigators: Study Director: Marc Engelhardt, MD, Basilea Pharmaceutica International Ltd

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: July 12, 2011
• First Submitted That Met QC Criteria: July 19, 2011
• First Posted (Estimate): July 20, 2011

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: CDI-CS-001