BOLD-100 in Combination With FOLFOX for the Treatment of Advanced, Solid Tumours

Learn more about:
Related Clinical Trial
Liver Embolization Approaches for Tumor Management Study on the Accuracy of Proteomics in Evaluating Lymph Node Metastasis Status in Cholangiocarcinoma Patients Evaluation of the Patient’s Experience in Medical Studies for Cholangiocarcinoma Looking At Bile Duct Cancer Patient Experience Patterns in Medical Trials Advanced or Metastatic Cholangiocarcinoma Study of [18F]FAPI-74 PET in Patients With Gastrointestinal Cancers Study on Consistency Evaluation for Drug Sensitivity of Patient-Derived Organoid Model From Cholangiocarcinoma Patients Screening Single-operator Cholangioscopy for Neoplastic Bile Duct Lesions EUS-guided Choledochoduodenostomy for Primary Drainage of Malignant Distal Biliary Obstruction An Exploratory Clinical Study of Photodynamic Therapy Combined With Sonodynamic Therapy in Cholangiocarcinoma Bile Duct Drainage After ERCP Failure: EUS-BD vs PTBD Safety and Efficacy of PDT vs RFA vs PDT+RFA for the Treatment of Extrahepatic Cholangiocarcinoma FLUOPANC-trial – Fluorescence-guided Surgery of Pancreatic and Bileduct Tumors Using cRGD-ZW800-1 Phase Ib Trial of Infigratinib In Combination With Atezolizumab And Bevacizumab for The Second-Line Treatment of Advanced Cholangiocarcinoma With FGFR2 Fusion/Amplification Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers Minimally Invasive Pancreatoduodenectomy for Distal Cholangiocarcinoma QoL After Liver Surgery CH-EUS in Diagnosis of Inoperable Bile Duct Tumors Treatment of ARB202 Advanced Gastrointestinal Cancer Patients Long-Term Follow-up Study of Subjects Treated With Autologous T Cells Using the Sleeping Beauty System to Express TCRs Implementation and Quality Assurance of DPYD-genotyping in Patients Treated With Fluoropyrimidines. GEMOX Combined With Targeted Therapy and Immunotherapy for Patients With Advanced Cholangiocarcinoma PD-1 Inhibitor Sintilimab Combined With Capecitabine for Adjuvant Treatment After Radical Resection of Cholangiocarcinoma. Phase I/II Study of Autologous T Cells to Express T-Cell Receptors (TCRs) in Subjects With Solid Tumors Molecular Epidemiology of Biliary Tree Cancers Prognostic Factors in Periampullary Tumors and Cysts RALOX as Second Line Treatment for Advanced Malignant Biliary System Tumor HLA Typing and Tumor Neoantigen Identification for a Phase I/II Study of Autologous TCR-T Cells in Subjects With Solid Tumors First in Human Study to Evaluate AZD8205 in Patients With Advanced or Metastatic Solid Malignancies Early Access Program Providing HER2/HER3 Bispecific Antibody, MCLA-128, for a Patient With Advanced NRG1-Fusion Positive Solid Tumor Deep Liver Phenotyping and Immunology Study A Study of MGD013 in Patients With Unresectable or Metastatic Neoplasms Radio Frequency Ablation in the Management of Pancreatico-biliary Disorders: A Multicenter Registry. Maintenance Niraparib and Dostarlimab in Advanced Cholangiocarcinoma A Phase I Study of WM-S1-030 in Patients With Advanced Solid Tumors Niraparib Combined With Anlotinib in Homologous Recombination Repair (HRR) Gene-mutated Advanced Solid Tumors The Comparison of Miniinvasive and Open Pancreaticoduodenectomy for Cancer Pancreaticobiliary Zone Crossover Relative Bioavailability and Dose Escalation Study of TT-00420 Tablet in Patients With Advanced Solid Tumors Neoadjuvant Bintrafusp Alfa in Patients With Resectable Biliary Tract Cancer Open-Label Study for Safety, Tolerability, PK and Anti-Tumor Activity of STP705 Administered Intratumorally in Cholangiocarcinoma, Hepatocellular Carcinoma or Liver Metastases in Subjects With Advanced/Metastatic or Surgically Unresectable Solid Tumors Who Are Refractory to Standard Therapy A Study of the Use of the Medtronic Pump and Codman Catheter to Give Chemotherapy to Patients With Colorectal Carcinoma or Cholangiocarcinoma LYT-200 Alone and in Combination With Chemotherapy or Anti-PD-1 in Patients With Metastatic Solid Tumors Lenvatinib in Patients With Previously Treated Advanced Biliary Tract Cancer A Study of BMS-936558 With SBRT After Induction Chemotherapy in Cholangiocarcinoma Apatinib Plus Camrelizumab in Patients With Previously Treated Advanced Biliary Tract Cancer Phase I/II Study Evaluating Safety and Efficacy of Tivozanib (AV-951) in Cholangiocarcinoma ENHANCED RECOVERY AFTER BILIARY TRACT SURGERY Recurrence After Whipple’s (RAW): Retrospective Cohort Study Investigating Patterns of Cancer Recurrence Following Pancreaticoduodenectomy for Pancreatic Head Malignancy Implementing Acupuncture and Chinese Herbal Medicine Into Palliative Care Prospective Evaluation of Biliary Tissue Sampling With ERCP Combination of Trametinib (MEK Inhibitor) and Hydroxychloroquine (HCQ) (Autophagy Inhibitor) in Patients With KRAS Mutation Refractory Bile Tract Carcinoma (BTC). DNA Methylation Biomarker for Diagnosis of Cholangiocarcinoma in Patients With Bile Duct Stricture Liver Cancer Registry Platform Target Rare Cancer Knowledge Neoadjuvant Therapy in Biliary Adenocarcinoma BOLD-100 in Combination With FOLFOX for the Treatment of Advanced, Solid Tumours the Impact of Early Palliative Care on the Survival of Locally Advanced and / or Metastatic Cholangiocarcinoma Patients Nutritional Preferences and Product Accessibility in Oral Nutritional Supplements in Participants With Breast, Colorectal, Upper Gastrointestinal, or Prostate Cancer High Volume Washing of the Abdomen in Increasing Survival After Surgery in Patients With Pancreatic Cancer That Can Be Removed by Surgery Short-term Starvation vs. Normal Diet Before Chemotherapy of Solid Tumors Evaluation of MRI Sequences for Ultra-rapid Acquisition of Bile Ducts Images Study of Oral Ceritinib in Patients With ALK and ROS1 Activated Gastrointestinal Malignancies Obtaining Solid Tumor Tissue From People Having Biopsy or Surgery for Certain Types of Cancer Improving Outcomes in Cancer Patients With a Nutritional and Physical Conditioning Prehabilitation Program 18F-FSPG PET in Imaging Patients With Liver Cancer Before Undergoing Surgery or Transplant A Clinical Trial to Evaluate Safety and Efficacy of Endovascualr Denervation in Treatment of Cancer Pain Comparison Between Internal and External Preoperative Biliary Drainage in Periampullary Cancers A Study of TRK-950 in Combinations With Anti-Cancer Treatment Regimens in Patients With Advanced Solid Tumors Anesthetic Agents and Acute Kidney Injury After Liver Resection Surgery Efficacy of Fistulotomy for Biliary Cannulation A Study of LY3039478 in Participants With Advanced or Metastatic Solid Tumors Etomidate vs. Midazolam for Sedation During ERCP Loop-tipped Guidewire in Selective Biliary Cannulation Pancreatic Head and Peri-ampullary Cancer Laparoscopic vs Open Surgical Treatment Trial (PLOT) Effects of OXY111A in Primary and Secondary Hepato-Pancreato-Biliary Neoplasm BKM120 in Cancers With PIK3CA Activating Mutations A First-in-human Phase Ia/b, Open Label, Multicentre, Dose Escalation Study of BI 905711 in Patients With Advanced Gastrointestinal Cancers Infigratinib for the Treatment of Advanced or Metastatic Solid Tumors in Patients With FGFR Gene Mutations Changes in Liver Function After Stereotactic Body Radiation Therapy Measured by PET/CT PTFE Stents for Treatment of Malignant Biliary Strictures Irreversible Electroporation of Unresectable Liver Tumors Personal Resilience Empowerment Program Study Radiofrequency Ablation for Biliopancreatic Malignancy Early Enteral Feeding After Pylorus Preserving Pancreatoduodenectomy Influence of an Oral Nutritional Supplement Rich in Omega-3 Fatty Acids on Functional State and Quality of Life in Malnourished Patients With Gastroenterological Tumors National Translational Science Network of Precision-based Immunotherapy for Primary Liver Cancer In Vitro Models of Liver and Pancreatic Cancer Biliary Tissue Sampling Using a Cytology Brush or the GIUM Catheter Evaluation of Stereotactic Radiosurgery For Liver Malignancies Beacon BNX™ Endoscopic Ultrasound (EUS)-Needle vs SharkCore™ Needle A Pilot Study to Assess Theragnostically Planned Liver Radiation With Functional DVH Analysis to Optimize Individualized Radiation Therapy Radiofrequency Ablation Using Octopus Electrodes for Treatment of Focal Liver Malignancies Accuracy of Endoscopic Ultrasound for Detection of Tumors of the Liver Prospective Study of the Risk of Bacteremia in Directed Cholangioscopic Examination of the CBD Margin Status After Pancreaticoduodenectomy for Cancer A Pilot Study of Combined Immune Checkpoint Inhibition in Combination With Ablative Therapies in Subjects With Hepatocellular Carcinoma (HCC) or Biliary Tract Carcinomas (BTC) Study of Olaparib and Durvalumab in IDH-Mutated Solid Tumors Comparison Bile Duct Brushings, Cholangioscopy-Directed Biopsies and Pediatric Forceps Biopsies in Biliary Strictures Effects of Preoperative Immunonutrition in Patients Undergoing Pancreaticoduodenectomy A Study of BBI503 in Adult Patients With Advanced Hepatobiliary Cancer A Study of TRK-950 in Patients With Advanced Solid Tumors Combined HCC-MFCCC Proton Therapy and Bevacizumab for Primary Liver Tumors Effects of Preoperative Immunonutrition in Patients Undergoing Hepatectomy Proton Beam Irradiation for the Treatment of Unresectable Hepatocellular Cancer or Hepatic Metastases Fluorescence QRH-882260 Peptide Imaging in the Bile Duct A Phase 1 Study of ZSP1241 in Participants With Advanced Solid Tumors pCLE For the Diagnosis Of Cancer in Unknown Bile Duct Stricture Unilateral Versus Bilateral Stents for Bismuth Type II and III Malignant Hilar Strictures Yttrium-90 Radioembolization Using Glass Microspheres (TheraSphere) for Patients With Liver Metastases Olaparib in Treating Patients With Advanced Glioma, Cholangiocarcinoma, or Solid Tumors With IDH1 or IDH2 Mutations Study of Sildenafil as a Therapy for Fatigue in Pancreatic Cancer Study of Gemcitabine With TheraSphere® (Yttrium-90)in Patients With Hepatic Tumors of Pancreatobiliary Origin Radiation Therapy in Treating Patients With Hepatocellular Carcinoma, Cholangiocarcinoma, or Liver Metastasis Who Have Impaired Liver Function Phase 1 In-vivo Biliary Study of KSP/QRH Heptapeptide Dimer MRCP Diagnoses EHCC Better When Combined DWI Safety and Efficacy of Modified Folfirinox Versus Gemcis in Bile Duct Tumours Comparison of Biliary Forceps Biopsy and Brush Cytology Perioperative MVT-5873, a Fully Human Monoclonal Antibody Against a CA 19-9 Epitope, for Operable CA 19-9 Producing Pancreatic Cancers, Cholangiocarcinomas, and Metastatic Colorectal Cancers Pilot Study of Irreversible Electroporation (IRE) to Treat Metastatic Liver Cancer & Cholangiocarcinoma Endoscopic Bipolar Radiofrequency Probe (ENDOHPB) in the Management of Unresectable Bile Duct and Pancreatic Cancer A Registry of Patients Undergoing Cellvizio Endomicroscopy and Endoscopic Retrograde Cholangiopancreatography(ERCP) Imaging Procedures for Diagnosing Pancreatic and Bile Duct Cancers Cyclooxygenase-2 Inhibitor for Adjuvant Anticancer Effect in Patients With Biliary-pancreas Cancer Endobiliary RFA for Unresectable Malignant Biliary Strictures A Clinical Trial of Entinostat in Combination With Nivolumab for Patients With Previously Treated Unresectable or Metastatic Cholangiocarcinoma and Pancreatic Adenocarcinoma Clinical Effect and Safety of PDT and RFA for Unresectable EHCC Safety and Efficiency of Photodynamic Therapy for Blie Duct Carcinoma Gemcitabine With Peptide Vaccine Therapy in Treating Patients With Bile Duct Cancer A Study of the Use of the Medtronic Pump and Codman Catheter to Give Chemotherapy to Patients With Colorectal Carcinoma or Cholangiocarcinoma Trial of IRE in Cholangiocarcinoma Intra-hepatic Chemotherapy in Patient With Non-resectable Liver Metastases From Cholangiocarcinoma Chemo Alone or in Combination With Radiation in Unresectable Cholangiocarcinoma ASLAN001 in Patients With Advanced or Metastatic Cholangiocarcinoma Who Progressed on at Least 1 Line of Systemic Therapy A Study of Gemcitabine as an Adjuvant Treatment for Cholangiocarcinoma After Surgical Resection Efficiency Evaluation of Photodynamic Therapy With Photofrin® on Unresectable Type III or IV Cholangiocarcinomas PCI Treatment/Gemcitabine & Chemotherapy vs Chemotherapy Alone in Patients With Inoperable Extrahepatic Bile Duct Cancer S-1 in Combination With Abraxane in Treating Cholangiocarcinoma Phase II Trial of Nab-Paclitaxel and Gemcitabine for First-Line Treatment of Patients With Cholangiocarcinoma Combination Chemotherapy Plus Panitumumab or Bevacizumab for Inoperable Cholangiocarcinoma Without KRAS Mutations A Phase I/II Safety and Efficacy Study of PCI of Gemcitabine and Chemotherapy in Patients With Cholangiocarcinomas Comparison of Endoscopic Radiofrequency Ablation Versus Photodynamic Therapy for Inoperable Cholangiocarcinoma Diagnosis, Treatment Status and Prognosis of Cholangiocarcinoma in China: a Multicenter, Two-way, Non-intervention Study Gemcitabine/Oxaliplatin and Photodynamic Therapy in Cholangiocarcinoma Efficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Who Failed Previous Therapy – (FIGHT-202) Pemigatinib in Treating Patients With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Including FGFR2 Rearrangement Radiofrquency Ablation Combined With Cytokine-induced Killer Cells for the Patients With Cholangiocarcinoma Chart Review: Unresectable/Metastatic Cholangiocarcinoma Treated With Irinotecan, Capecitabine and Celecoxib Study of TRIFLURIDINE/TIPIRACIL in Previously Treated Cholangiocarcinoma Study Of Intrahepatic Arterial Injection of 90-Y Glass Microspheres for Cholangiocarcinoma Combined Biological Treatment and Chemotherapy for Patients With Inoperable Cholangiocarcinoma Neoadjuvant mFOLFOXIRI for Potentially Resectable Cholangiocarcinoma Gemcitabine, Oxaliplatin and Capecitabine in Patients With Advanced Cholangiocarcinoma Registry Study of Neoadjuvant Chemoradiation & Transplant for Cholangiocarcinoma Patients Study of RAD001 in Advanced Cholangiocarcinoma: RADiChol Study of Pembrolizumab and Olaparib in Bile Duct Cancer Cohort of Patients With Hepatocellular Carcinoma or Cholangiocarcinoma Second Line Chemotherapy FOLFIRINOX in Irresectable Cholangiocarcinoma ncRNAs in Exosomes of Cholangiocarcinoma Single Arm Study of RAD001 as Monotherapy in Treatment in Advanced Cholangiocarcinoma Trial of Therapeutic Vaccine in Patients With Cholangiocarcinoma

Brief Title

BOLD-100 in Combination With FOLFOX for the Treatment of Advanced Solid Tumours

Official Title

A Phase 1b/2a Dose Escalation Study of BOLD-100 in Combination With FOLFOX Chemotherapy in Patients With Advanced Solid Tumours

Brief Summary

      BOLD-100 is an intravenously administered sterile solution containing the ruthenium-based
      small molecule. BOLD-100 has been shown to preferentially decrease the expression of GRP78 in
      tumour cells and ER stressed cells when compared to normal cells. BOLD-100 will be combined
      with cytotoxic FOLFOX chemotherapy in this study, with a dose escalation cohort to ensure
      tolerability and safety, followed by a cohort expansion phase.
    


Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Incidence and severity of adverse events (AEs) according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0

Secondary Outcome

 Progression Free Survival (PFS); Overall Response Rate (ORR); Overall Survival (OS)

Condition

Colorectal Cancer

Intervention

BOLD-100 in combination with FOLFOX Chemotherapy (Dose Expansion)

Study Arms / Comparison Groups

 Part B - Dose Expansion - 1L Gastric Cancer (ARM I)
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

100

Start Date

August 28, 2020

Completion Date

September 30, 2024

Primary Completion Date

December 31, 2023

Eligibility Criteria

        Inclusion Criteria:

          1. Be 18 years or older.

          2. Be male or non-pregnant females who agree to comply with applicable contraceptive
             requirements of the protocol (see Table 12. Acceptable Contraceptive Methods.)

          3. Histologically and/or cytologically confirmed gastrointestinal tumours that are
             metastatic or unresectable, and are subject to receive FOLFOX as SOC per
             investigator's judgement. Participants will have received at least one line of
             chemotherapy in the metastatic setting. Colorectal cancer: Patients must have received
             at least 1 prior line of therapy prior to enrollment in this study. Pancreatic cancer:
             Patients must have received at least 1 prior line of therapy. Gastric cancer: Patients
             who have not received prior treatment may be included in this study. GEJ
             (gastroesophageal junction) cancer patients are considered eligible to enter this
             trial. Cholangiocarcinoma: locally advanced or metastatic biliary tract cancer (intra
             or extrahepatic cholangiocarcinoma or gallbladder cancer) are eligible to enter this
             trial. Patients must have received at least 1 prior line of therapy (with
             gemcitabine-based chemotherapy). Colorectal cancer (ARM VI): Patients must have
             received at least 2 prior lines of therapy prior to enrollment in this study, one of
             which was a 5-FU based regimen.

          4. Have measurable disease according to RECIST v1.1 (at least one measurable lesion).

          5. Have an anticipated survival of at least 16 weeks.

          6. Be ambulatory, with an Eastern Cooperative Oncology Group (ECOG) performance score of
             0 or 1.

          7. Have adequate organ function, defined as:

               1. Hematologic: ANC ≥ 1.5 x 109/L, Hgb ≥ 9.0 g/dL and platelet count ≥ 100 x 109/L

               2. Hepatic: total bilirubin ≤ 1.5 x ULN (or ≤ 3 x ULN for subjects with Gilbert's
                  Syndrome); transaminases ≤ 2.5 x ULN (may be up to ≤ 5x ULN if clearly due to
                  liver metastases) and ALP ≤ 2.5 x ULN (or ≤ 3 x ULN if liver metastases).

               3. Renal: serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min.

             c. Urine protein is 0, trace, or +1 on dipstick urinalysis, or < 1.0 gram on 24-hour
             urine protein analysis

          8. Be on stable doses of any drugs that may affect hepatic drug metabolism or renal drug
             excretion (e.g., non-steroidal anti-inflammatory drugs, corticosteroids, barbiturates,
             diphenylhydantoin, narcotic analgesics, probenecid). Such drugs should not be
             initiated while the subject is participating in this study or have been initiated
             within 30 days beforehand before the start of treatment. Whenever possible, narcotic
             analgesic doses should be stable within 30 days prior to study entry and during the
             first cycle of therapy.

          9. Resolved acute effects of any prior therapy before the start of treatment to baseline
             severity or grade ≤1 CTCAE 5.0 except for adverse events not constituting a safety
             risk by investigator judgment (such as alopecia)

         10. Able to take oral medications (for pre-medications and supportive management)

         11. Understand and be able, willing, and likely to fully comply with study procedures and
             restrictions.

         12. Be fully informed about their illness and the investigational nature of the study
             protocol, and sign a REB-approved Informed Consent Form (ICF).

        Exclusion Criteria:

          1. Neuropathy > grade 2

          2. Previous intolerance to or significant reaction secondary to fluorouracil or
             oxaliplatin

          3. Cerebrovascular accident within the past 6 months before the start of treatment.

          4. History or presence of central nervous system (CNS) metastasis or leptomeningeal
             tumours as documented by CT or MRI scan, analysis of cerebrospinal fluid or
             neurological exam.

          5. Any serious medical conditions that might be aggravated by treatment or limit
             compliance. This includes, but is not limited to uncontrolled psychiatric disorders,
             serious infections, active peptic ulcer disease and bleeding diathesis

          6. Any history of serious cardiac illness including (but not confined to):

               -  Previous or active myocardial infarction < 6 months before the start of treatment

               -  Congestive cardiac failure (NYHA III or IV)

               -  History of unstable angina pectoris < 6 months before the start of treatment

               -  Recent coronary artery bypass grafting < 6 months before the start of treatment

               -  Uncontrolled hypertension (systolic ≥ 140 mmHg or diastolic ≥ 90 mmHg)

               -  Ventricular arrhythmia < 6 months before the start of treatment

               -  Left ventricular ejection fraction (LVEF) < 50% as measured either by
                  radionuclide angiography or echocardiogram

               -  QTc interval > 470 msec

          7. Hemoptysis, cerebral, or clinically significant gastrointestinal hemorrhage in the
             past 6 months before the start of treatment

          8. Any other known malignancy within 3 years before the start of treatment (with the
             exception of non-melanoma skin cancer that had undergone curative treatment, cervical
             cancer in situ, or ductal/lobular carcinoma in situ of the breast that has underwent
             local treatment

          9. Active gastrointestinal tract disease with malabsorption syndrome.

         10. Non-healing wound, fracture, or ulcer, or presence of symptomatic peripheral vascular
             disease.

         11. Treatment with radiation therapy or surgery within 4 weeks prior to starting
             treatment.

         12. Recent history of weight loss > 10% of current body weight in past 3 months before the
             start of treatment.

         13. Current (within 1 week of the start of the study) or regular use of any medication
             (including OTC, herbal or homeopathic preparations) that could affect (improve or
             worsen) the cancer being studied, or could affect the action or disposition of
             BOLD-100, or its clinical or laboratory assessment, e.g., Coumadin therapy, due to
             high competitive protein binding.

         14. HIV-positive subjects on combination anti-retroviral therapy due to the potential for
             PK interactions with the study agent.

         15. Any condition potentially decreasing compliance to study procedures. Concurrent use of
             another investigational therapy or anti-cancer therapy.

         16. Concurrent use of another investigational therapy or anti-cancer therapy within 4
             weeks before the start of treatment.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, 604-262-9899, [email protected]

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT04421820

Organization ID

BOLD-100-001


Responsible Party

Sponsor

Study Sponsor

Bold Therapeutics, Inc.


Study Sponsor

, , 


Verification Date

February 2023