An open-label, multi-center, 2-arm PhaseI/II trial of LBY135 alone and in combination with capecitabine in advanced solid tumors

Completed

Conditions: Advanced solid tumors and Colorectal Cancer
10027476

Registration Number: NL-OMON29725

Lead Sponsor: ovartis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 25

Inclusion Criteria

• Arm 1:Patients with an advanced solid tumor who have progressed despite standard therapy or for which standard treatment options do not exist
• Arm 2: Patients with an advanced solid tumor who have progressed or for which standard treatment options do not exist, and who are considered appropriate for capecitabine treatment
• Patients must have adequate bone marrow function, no severe liver and kidney functions disorder.
Additional inclusion criteria for CRC dose expansion cohorts (Arm 1B/2A):
• Arm 1B (single agent LBY135): Patients with histologically-confirmed diagnosis of CRC (advanced unresectable or metastatic disease - stages IV and IIIb AJCC criteria) and for whom standard treatment options do not exist
• Arm 2 (LBY135 plus capecitabine): Patients with histologically-confirmed diagnosis of CRC (advanced unresectable or metastatic disease stages IV and IIIb AJCC criteria), who are relapsed after or refractory to at least one but not more than two prior systemic therapies (i.e. chemotherapies, targeted therapies or immunotherapies) for unresectable or metastatic disease.

Exclusion Criteria

• A history or presence of primary central nervous system tumors or brain metastases
• Acute or chronic liver disease or renal disease
• Patients with any peripheral neuropathy >= CTCAE grade 2
• Patients with unresolved diarrhea >= CTCAE grade 2
• Any of the following concurrent severe and/or uncontrolled medical conditions:
Impaired cardiac function or clinically significant cardiac diseases; symptomatic congestive heart failure; labile hypertension; uncontrolled diabetes, active or uncontrolled infection
• Patients with known autoimmune disease
• Patients with known anti-murine antibody responses
• Patients who have been treated with any hematopoietic colony-stimulating growth factors <= 2 weeks prior to starting study drug
• Use of Corticosteroids or any other immunosuppressive treatment at start of study
• Chemotherapy, targeted therapy or immunotherapy at least 4 weeks prior to start of study
• Any continuous-dosing therapeutic modalities or investigational drug <= 5 half lives prior to starting study drug
• Wide field radiotherapy <= 4 weeks or limited field radiation for palliation <= 2 weeks prior to starting study drug.
• Patients who have undergone major surgery <= 2 weeks
• Women who are pregnant or breast feeding.
• Known HIV infection

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To determine the maximum-tolerated dose (MTD) and doselimiting<br /><br>toxicity (DLT) of single agent LBY135 and LBY135 when administered in<br /><br>combination<br /><br>with capecitabine, by increasing the dose in cohorts of minimum of 3 patients.</p><br>

Secondary Outcome Measures