A First-in-human Phase Ia/b, Open Label, Multicentre, Dose Escalation Study of BI 905711 in Patients With Advanced Gastrointestinal Cancers

Learn more about:
Related Clinical Trial
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

A First-in-human Phase Ia/b, Open Label, Multicentre, Dose Escalation Study of BI 905711 in Patients With Advanced Gastrointestinal Cancers

Official Title

A First-in-human Phase Ia/b, Open Label, Multicentre, Dose Escalation Study of BI 905711 in Patients With Advanced Gastrointestinal Cancers

Brief Summary

      Phase Ia - Explore safety and establish the maximum tolerated dose (MTD)/recommended dose
      levels for phase Ib expansion phase of BI 905711 based on the frequency of patients
      experiencing dose limiting toxicities (DLTs) during the MTD evaluation period. The MTD
      evaluation period is defined as the first two treatment cycles (from first dose
      administration until the day preceding the third dose administration or end of REP in case of
      discontinuation before start of Cycle 3).

      Phase Ia - Explore pharmacokinetics/pharmacodynamics, and efficacy to guide the determination
      of a potentially effective dose range for phase Ib in the absence of MTD.

      Phase Ib - Evaluate efficacy and safety of BI 905711 at a potentially effective dose range
      and determine the Recommended Phase 2 Dose (RP2D)
    


Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Phase Ia - Maximum tolerated dose (MTD) defined as the highest dose with less than 25% risk of the true DLT rate being equal or above 33% during the MTD evaluation period

Secondary Outcome

 Phase Ia - Cmax: maximum measured concentration of BI 905711 in plasma

Condition

Gastrointestinal Neoplasms

Intervention

BI 905711

Study Arms / Comparison Groups

 BI 905711
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

140

Start Date

March 11, 2020

Completion Date

March 1, 2023

Primary Completion Date

February 3, 2023

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically or cytologically confirmed, advanced unresectable or metastatic
             gastrointestinal cancers of following histologies:

               -  Colorectal adenocarcinoma

               -  Gastric adenocarcinoma

               -  Esophageal adenocarcinoma

               -  Pancreatic adenocarcinoma

               -  Cholangiocarcinoma and gallbladder carcinoma

          -  Patient who has failed all available conventional therapies known to confer clinical
             benefit for their disease based on local approved standards. For patients with
             colorectal cancer, prior treatment with regorafenib or TAS-102 is optional.

          -  Phase Ia (dose escalation) only: Patient with either measurable or
             non-measurable/non-evaluable disease.

          -  Phase Ia (expanded cohort) and Phase Ib (expansion phase) only: At least one target
             lesion that can be accurately measured per RECIST v.1.1

          -  Availability and willingness to undergo tumor biopsy before treatment to provide tumor
             tissue. Pre-treatment fresh tumor biopsy collections for biomarker analyses are
             considered optional in phase Ia and mandatory in phase Ib. However, fresh tumor
             biopsies will NOT be considered if significant risk procedures are required including
             (but not limited to) biopsies of the pancreas, or endoscopic procedures extending
             beyond the esophagus, stomach or bowel. Only non-significant risk procedures per the
             investigator's judgment will be used to obtain any biopsies specified in this study.
             In case a fresh tumor biopsy cannot be obtained due to before mentioned reasons an
             archived tumor tissue specimen needs to be submitted.

          -  Adequate hepatic, renal and bone marrow functions as defined by all of the below:

               -  Total bilirubin ≤ 1.5 x institutional Upper Level of Normal (ULN) (≤ 3 x
                  institutional ULN for patient with Gilbert's syndrome)

               -  ALT and AST ≤2.5 x institutional ULN (≤5 x institutional ULN for patients with
                  known liver metastases)

               -  Serum creatinine ≤1.5x institutional ULN. If creatinine is > 1.5 x ULN, patient
                  is eligible if concurrent creatinine clearance ≥ 50 ml/min (measured or
                  calculated by CKD-EPI formula or Japanese version of CKD-EPI formula for Japanese
                  patients).

               -  ANC ≥ 1.0x 10^9/L

               -  Platelets ≥ 100x10^9/ L

               -  Hb ≥9.0 g/dl (without transfusion within previous week)

               -  Serum lipase ≤ 1.5 institutional ULN

          -  Recovery from any adverse events according to Common Terminology Criteria for Adverse
             Events (CTCAE) v5.0 of previous anti-cancer therapies to baseline or CTCAE grade 1,
             except for alopecia CTCAE grade 2, sensory peripheral neuropathy CTCAE grade ≤ 2 or
             considered not clinically significant.

          -  Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

          -  Life expectancy ≥ 3 months in the opinion of the investigator

          -  Of legal adult age (according to local legislation) at screening

          -  Signed and dated written informed consent in accordance with ICH-GCP and local
             legislation prior to admission to the trial.

          -  Male or female patients. Women of childbearing potential (WOCBP) and men able to
             father a child must be ready and able to use highly effective methods of birth control
             per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used
             consistently and correctly.

        Exclusion Criteria:

          -  Treatment with a systemic anti-cancer therapy or investigational drug within 14 days
             or 5 half-lives (whichever is shorter) of the first treatment with the study
             medication.

          -  Radiation therapy with extensive large field involving parenchymal organs in chest,
             abdomen or pelvis within 3 weeks of the first treatment in the study. There is no
             restriction for minor small field radiotherapy.

          -  Any serious concomitant disease or medical condition affecting compliance with Trial
             requirements or which are considered relevant for the evaluation of the efficacy or
             safety of the trial drug, such as neurologic, psychiatric, infectious disease or
             active ulcers (gastro-intestinal (GI) tract, skin) or laboratory abnormality that may
             increase the risk associated with trial participation or trial drug administration,
             and in the judgment of the Investigator, would make the patient inappropriate for
             entry into the trial.

          -  Known pathological condition of GI tract, liver and pancreas, excluding the disease
             under study, that may interfere with assessment of drug safety or may increase the
             risk of toxicity:

               -  inflammatory bowel disease

               -  chronic pancreatitis

               -  other serious GI pathological conditions by judgment of the investigator e.g.
                  autoimmune disease with GI involvement, unexplained active diarrhea CTCAE grade
                  ≥2 according to CTCAE v5.0.

          -  Known history of human immunodeficiency virus infection.

          -  Any of the following laboratory evidence of hepatitis virus infection. Test results
             obtained in routine diagnostics are acceptable if done within 14 days before the
             informed consent date:

               -  Positive results of hepatitis B surface (HBs) antigen

               -  Presence of HBc antibody together with HBV-DNA

               -  Presence of hepatitis C RNA

          -  Active concomitant malignancies, other than the one treated in this trial.

          -  Chronic alcohol or drug abuse or any condition that, in the investigator's opinion,
             makes the patient an unreliable trial participant or unlikely to comply with the
             protocol requirements or not expected to complete the trial as scheduled.

          -  Women who are pregnant, nursing, or who plan to become pregnant while in the trial;
             female patients who do not agree to the interruption of breast feeding from the start
             of study treatment to within 30 days after the last study treatment.

          -  Presence of uncontrolled or symptomatic brain or subdural metastases. Inclusion of
             patients with brain metastases who have completed local therapy and are considered
             stable by the investigator, or with newly identified asymptomatic brain metastases at
             screening will be allowed. Use of corticosteroids is allowed if the dose was stable
             for at least 1 week before the baseline MRI.

          -  Patients who are under judicial protection and patients who are legally
             institutionalized

          -  Major surgery (major according to the investigator's assessment) performed within 3
             weeks prior to treatment start or planned within 3 months after screening, e.g. hip
             replacement.

          -  Any of the following cardiac criteria:

               -  Resting corrected QT interval (QTc) >470 msec

               -  Any clinically important abnormalities (as assessed by the Investigator) in
                  rhythm, conduction, or morphology of resting ECGs, e.g., complete left bundle
                  branch block, third degree heart block

               -  Patients with an ejection fraction (EF) <50% or the lower limit of normal of the
                  institutional standard will be excluded. Only in cases where the Investigator (or
                  the treating physician or both) suspects cardiac disease with negative effect on
                  the EF, will the EF be measured during screening using an appropriate method
                  according to local standards to confirm eligibility (e.g., echocardiogram,
                  multi-gated acquisition scan). A historic measurement of EF no older than 6
                  months prior to first administration of study drug can be accepted provided that
                  there is clinical evidence that the EF value has not worsened since this
                  measurement in the opinion of the Investigator or of the treating physician or
                  both.

          -  Known hypersensitivity to the trial medication and/or its components i.e. polysorbate
             20, sodium citrate, lysine hydrochloride, sucrose, citric acid.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, 1-800-243-0127, [email protected]

Location Countries

Germany

Location Countries

Germany

Administrative Informations


NCT ID

NCT04137289

Organization ID

1412-0001

Secondary IDs

2018-003268-29

Responsible Party

Sponsor

Study Sponsor

Boehringer Ingelheim


Study Sponsor

, , 


Verification Date

October 2020