CBP501, Cisplatin and Nivolumab in Advanced Refractory Tumors

Description

This is a multicenter, open-label, phase 1b study of CBP501/cisplatin/nivolumab combination administered once every 21 days to patients with advanced solid tumors.

Study Start Date

October, 25 2017

Estimated Completion Date

March 2019

Interventions

  • Drug: CBP501

Study ID

CanBas Co. Ltd. -- CBP17-01

Status

Recruiting

Trial ID

NCT03113188

Study Type

Interventional

Trial Phase

Phase 1

Enrollment Quota

42

Sponsor

CanBas Co. Ltd.

Inclusion Criteria

    1. Signed informed consent obtained prior to initiation of any study-specific procedures and treatment 2. Previously treated, pathologically confirmed, locally advanced or metastatic solid tumors with measurable disease 3. Male or female patients aged ? 18 years at time of informed consent 4. ECOG Performance Status (PS) 0-1 5. Life expectancy > 3 months 6. Previous anticancer treatment must be discontinued at least 3 weeks prior to the initiation of study treatment (6 weeks for mitomycin C 6 weeks for anti-androgen therapy if discontinued prior to treatment initiation, except 8 weeks for bicalutamide) 7. Adequate bone marrow reserve, cardiac, liver, renal and metabolic function:
  • absolute neutrophil count (ANC) ? 1.5 x 109/L
  • platelet count ? 100 x 109/L
  • hemoglobin ? 9 g/dL
  • white blood cell count (WBC) ? upper limit of normal (ULN)
  • creatinine phosphokinase isozymes CPK-MB and CPK-MM ? ULN
  • serum troponin T levels within normal limits
  • bilirubin ? 1.5 x ULN
  • alanine aminotransferase (ALT, SGPT) and aspartate aminotransferase (AST, SGOT) ? 2.5 x ULN (? 5 x ULN if liver metastases are present)
  • INR ? 1.5 x ULN
  • creatinine clearance ? 60 mL/min (Cockroft & Gault formula)
  • serum potassium NCI-CTCAE version 4.03 Grade <2
  • serum calcium NCI-CTCAE version 4.03 Grade <2
  • serum magnesium NCI-CTCAE version 4.03 Grade <2
  • 8. Female patients of child-bearing potential must have a negative pregnancy test and use at least one form of contraception as approved by the investigator for 4 weeks prior to initiating study treatment and 4 months after the last dose of study drug. For the purposes of this study, child-bearing potential is defined as "all female patients unless they are post-menopausal for at least 3 years or surgically sterile" 9. Male patients must use a form of barrier contraception approved by the investigator during the study and for 4 months after the last dose of study drug 10. Ability to cooperate with study treatment and follow-up.

Exclusion Criteria

    1. Radiation therapy to >30% of bone marrow prior to study entry 2. Prior chemotherapy with nitrosoureas, prior mitomycin C cumulative dose ? 25 mg/m2, prior bone marrow transplant, or prior intensive chemotherapy with stem cell support 3. Presence of any serious concomitant systemic disorders incompatible with the study in the opinion of the investigator (e.g., uncontrolled congestive heart failure, active infection, etc.) 4. Any previous history of another malignancy (other than cured basal cell or squamous cell carcinoma of the skin or cured in-situ carcinoma) within 5 years of study entry 5. Presence of any significant central nervous system (CNS) or psychiatric disorder(s) that would hamper the patient's compliance 6. Evidence of peripheral neuropathy > grade 1 by NCI-CTCAE version 4.03 7. Treatment with any other investigational agent or participation in another clinical trial within 28 days prior to study entry 8. Pregnant or breast-feeding patients or any patient with child-bearing potential not using adequate contraception 9. Known HIV, HBV, or HCV infection 10. Active CNS metastases however, patients with CNS metastases will be eligible if they have been treated and are stable without symptoms for 4 weeks after completion of treatment, with image documentation required, and must be off steroids.

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (12)

Study Location Distance Name Phone Email
Dana Faber Cancer Institute - Boston, Massachusetts 2.4 miles Solida PruittThompson Sr RC 617-632-6718 SOLIDA_THOMPSON@dfci.harvard.edu
Dana Faber Cancer Institute - Boston, Massachusetts 2.4 miles Solida PruittThompson Sr RC 617-632-6718 SOLIDA_THOMPSON@dfci.harvard.edu
Dana Faber Cancer Institute - Boston, Massachusetts 2.4 miles Solida PruittThompson Sr RC 617-632-6718 SOLIDA_THOMPSON@dfci.harvard.edu
Dana Faber Cancer Institute - Boston, Massachusetts 2.4 miles Solida PruittThompson Sr RC 617-632-6718 SOLIDA_THOMPSON@dfci.harvard.edu
Dana Faber Cancer Institute - Boston, Massachusetts 2.4 miles Solida PruittThompson Sr RC 617-632-6718 SOLIDA_THOMPSON@dfci.harvard.edu
Dana Faber Cancer Institute - Boston, Massachusetts 2.4 miles Solida PruittThompson Sr RC 617-632-6718 SOLIDA_THOMPSON@dfci.harvard.edu
HonorHealth - Scottsdale, Arizona 2,286.1 miles Joyce Schaffer RN 480-323-1339 clinicaltrials@honorhealth.com
HonorHealth - Scottsdale, Arizona 2,286.1 miles Joyce Schaffer RN 480-323-1339 clinicaltrials@honorhealth.com
HonorHealth - Scottsdale, Arizona 2,286.1 miles Joyce Schaffer RN 480-323-1339 clinicaltrials@honorhealth.com
HonorHealth - Scottsdale, Arizona 2,286.1 miles Joyce Schaffer RN 480-323-1339 clinicaltrials@honorhealth.com
HonorHealth - Scottsdale, Arizona 2,286.1 miles Joyce Schaffer RN 480-323-1339 clinicaltrials@honorhealth.com
HonorHealth - Scottsdale, Arizona 2,286.1 miles Joyce Schaffer RN 480-323-1339 clinicaltrials@honorhealth.com

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