Advanced Solid Tumors MedDRA version: 20.0 Level: LLT Classification code 10065252 Term: Solid tumor System Organ Class: 100000004864 MedDRA version: 20.0 Level: LLT Classification code 10049280 Term: Solid tumour System Organ Class: 100000004864
Conditions
Interventions
Product Name: CCR2/5
Product Code: BMS-813160
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: NA
CAS Number: 1286279-29-5
Current Sponsor code: BMS-813160
Other descriptive name: BMS813160
Con
Sponsors
Bristol-Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Participants must have metastatic colorectal or pancreatic cancer - Eastern Cooperative Oncology Group (ECOG) performance status of =1 - Ability to swallow pills or capsules - All participants will be required to undergo mandatory pre and on-treatment biopsies - Adequate marrow function - Adequate other organ functions - Ability to comply with study visits, treatment, procedures, PK and PD sample collection, and required study follow-up Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 183 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 183
Exclusion criteria
Exclusion criteria: - Histology other than adenocarcinoma (neuroendocrine or acinar cell). If mixed tumor, the predominant histology must be adenocarcinoma; - Suspected, known, or progressive CNS metastases (Imaging required only if participants are symptomatic); Participants with adequately treated CNS metastasis are eligible if the participant’s neurologic function returned to baseline and are not currently on steroids for at least 2 weeks prior to study entry. Participants with history of brain metastasis require baseline MRI of the brain prior to study entry; - Participants with active, known or suspected autoimmune disease - Participants with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration except for adrenal replacement steroid doses > 10 mg daily prednisone equivalent in the absence of active autoimmune disease (Treatment with a short course of steroids (< 5 days) up to 7 days prior to initiating study treatment is permitted) - Interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected treatment-related pulmonary toxicity - Prior treatment with CCR2 and/or CCR5 inhibitors, PD-1, PD(L)-1 or CTLA-4 antibodies; - History of allergy to study treatments or any of its components of the study arm that participant is enrolling
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: PART 1: _To assess the safety and tolerability of BMS-813160 in combination with either FOLFIRI (Arm A), Gem + nabpaclitaxel (Arm B), or nivolumab (Arm C) in participants with advanced CRC or pancreatic cancer. _To assess the pharmacodynamic effects of BMS-813160 in tumor samples PART 2: _To assess the preliminary efficacy of BMS-813160 in combination with either FOLFIRI (Arm A), Gem + nab-paclitaxel or nivolumab + Gem + nab-paclitaxel (Arm B), or nivolumab (Arm C), and as monotherapy (Arm D) in participants with advanced CRC or pancreatic cancer;Secondary Objective: PART 1: _To assess the preliminary efficacy of BMS-813160 in combination with either FOLFIRI (Arm A), Gem + nabpaclitaxel (Arm B), or nivolumab (Arm C) in participants with advanced CRC or pancreatic cancer _To characterize the PK of BMS-813160 and its metabolite (BMS-939429) when administered alone, and in combination with either Gem + nab-paclitaxel, FOLFIRI or nivolumab; _To characterize the immunogenicity of nivolumab when administered in combination with BMS-813160 _ PART 2: _To assess the safety and tolerability of BMS-813160 in combination with either FOLFIRI (Arm A), Gem + nab-paclitaxel or nivolumab + Gem + nab-paclitaxel (Arm B) , or nivolumab (Arm C), and as monotherapy (Arm D) in participants with advanced CRC or pancreatic cancer; _To assess the pharmacodynamic effects of BMS-813160 in tumor samples;Primary end point(s): -Adverse events (AEs): Measured by incidence of AEs -Serious adverse events (SAEs): Measured by incidence of SAEs -AEs meeting protocol-defined dose limiting toxicity criteria: Measured by incidence of AEs that meet the protocol-defined dose limiting toxicity criteria -AEs leading to discontinuation: Measured by incidence of AEs leading to discontinuation -Death: Measured by incidence of deaths -Incidence of laboratory abnormalities: Measured by any laboratory test result that is clinically significant or meets the definition of an SAE, any laboratory test | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Maximum observed plasma concentration (Cmax), Time of maximum observed plasma concentration (Tmax), Trough observed plasma concentration (Ctrough), C24, Area under the concentration-time curve from time 0 to 8 hours postdose [AUC(0-8)], [AUC (24)], Apparent total body clearance (CLT/F), Accumulation index, calculated based on ratio of AUC(TAU) and Cmax at steady state to after the first dose (AI), Renal clearance (CLR), Percent urinary recovery over 24 hours corrected for molecular weight (%UR), Ratio of metabolite Cmax to parent Cmax, corrected for molecular (MR_Cmax), [MR_AUC(24)]; Frequency of positive anti-drug antibody (ADA) to nivolumab during combination therapy.;Timepoint(s) of evaluation of this end point: Approximately 4 years. | — |
Countries
Belgium, Canada, France, Germany, Italy, Spain, United States
Contacts
Public ContactGCT-SU
Bristol-Myers Squibb International Corporation
Outcome results
None listed