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This Study Aims to Find and Test a Safe Dose of BI 905677 in Patients With Different Types of Cancer (Solid Tumours)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03604445
Recruitment Status : Completed
First Posted : July 27, 2018
Last Update Posted : August 5, 2022
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE July 20, 2018
First Posted Date  ICMJE July 27, 2018
Last Update Posted Date August 5, 2022
Actual Study Start Date  ICMJE August 8, 2018
Actual Primary Completion Date July 27, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 20, 2018)
  • Maximum tolerated dose (MTD) of BI 905677 [ Time Frame: Up to 4 weeks ]
  • Number of patients experiencing adverse events (AEs) during the entire treatment period [ Time Frame: 18 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 20, 2018)
  • Cmax: maximum measured concentration of BI 905677 in serum after first infusion [ Time Frame: 24 hours ]
  • AUC0-tz: area under the serum concentration-time curve over the time interval from 0 to the last measured time point (tz) [ Time Frame: 18 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE This Study Aims to Find and Test a Safe Dose of BI 905677 in Patients With Different Types of Cancer (Solid Tumours)
Official Title  ICMJE An Open-label, Phase I Trial to Determine the Maximum-tolerated Dose and Investigate Safety, Pharmacokinetics and Efficacy of BI 905677 Administered Intravenously in Patients With Advanced Solid Tumours
Brief Summary

This study is open to adults with different types of advanced cancer (solid tumours). This study is open to people in whom previous treatments were not successful. The purpose of this study is to find out the highest dose of BI 905677 the participants can tolerate. BI 905677 is a type of an antibody that is being developed to treat cancer.

One dose of BI 905677 is given to the participants every 2 or 3 weeks as infusion into a vein. In this study, BI 905677 is given to humans for the first time. The participants visit the study site at least once a week so that the doctors can check their general health. The participants are in the study for as long as they benefit from and can tolerate treatment.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neoplasms
Intervention  ICMJE Drug: BI 905677
Solution for infusion
Study Arms  ICMJE Experimental: BI 905677
Schedule A: 3 week cycle (treatment every 3 weeks). Schedule B: 4 week cycle (treatment every 2 weeks). Recruitment into Schedule B will start after the MTD of Schedule A is reached.
Intervention: Drug: BI 905677
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 24, 2022)
37
Original Estimated Enrollment  ICMJE
 (submitted: July 20, 2018)
60
Actual Study Completion Date  ICMJE July 27, 2022
Actual Primary Completion Date July 27, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria

  • Histologically or cytologically confirmed diagnosis of an advanced, unresectable and/or metastatic non-haematologic malignancy. Patient must have measurable or evaluable lesions (according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1).
  • Patient who has failed conventional treatment or for whom no therapy of proven efficacy exists or who is not eligible for established treatment options. Patient must have exhausted treatment options known to prolong survival for their disease.
  • Patient willing to undergo mandatory skin biopsy at the timepoints specified in the protocol.
  • Eastern Cooperative Oncology Group score of 0 or 1.
  • Adequate organ function defined as all of the following:

    • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L; haemoglobin ≥ 9.0 g/dL; platelets ≥ 100 x 109/L without the use of hematopoietic growth factors within 4 weeks of start of study medication.
    • Total bilirubin ≤ 1.5 times the upper limit of normal (ULN), except for patients with Gilbert's syndrome: total bilirubin ≤ 3 x ULN or direct bilirubin ≤ 1.5 x ULN.
    • Creatinine ≤ 1.5 x ULN. If creatinine is > 1.5 x ULN, patient is eligible if concurrent creatinine clearance ≥ 50 ml/min (measured or calculated by CKDEPI formula or Japanese version of CKD-EPI formula for Japanese patients).
    • Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x ULN if no demonstrable liver metastases, or otherwise ≤ 5 x ULN
    • Alkaline Phosphatase < 5 x ULN
  • Recovered from any previous therapy-related toxicity to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 at start of treatment (except for alopecia and stable sensory neuropathy which must be ≤ CTCAE Grade 2).
  • At least 18 years of age at the time of consent or over the legal age of consent in countries where that is greater than 18 years.
  • Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
  • Life expectancy ≥ 3 months at the start of treatment in the opinion of the investigator.
  • Male or female patients. Women of childbearing potential (WOCBP) must only be included after a confirmed menstrual period within the past 4 weeks and a negative pregnancy test at screening. WOCBP with irregular menstruation may be included after two negative pregnancy tests during screening between 2 and 4 weeks apart. WOCBP and men who are 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. These methods must be used during the study and for at least 6 months after the last dose of BI 905677. A list of contraception methods meeting these criteria is provided in the patient information.

Exclusion criteria

  • Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to first trial treatment or planned within 6 months after screening.
  • Previous or concomitant malignancies other than the one treated in this trial within the last 2 years, except;

    • effectively treated non-melanoma skin cancers
    • effectively treated carcinoma in situ of the cervix
    • effectively treated ductal carcinoma in situ
    • other effectively treated malignancy that is considered cured by local treatment
  • Osteoporosis ≥ Common Terminology Criteria for Adverse Events (CTCAE) Grade 2
  • Chronic corticosteroid use
  • Osteoporotic compression fracture within 12 months prior to informed consent which is clinically significant in the opinion of the investigator.
  • Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
  • Previous treatment in this trial.
  • Treatment with a systemic anti-cancer therapy or investigational drug within 28 days or 5 half-lives (whichever is shorter) of the first treatment with the study medication.
  • Any history of or concomitant condition that, in the opinion of the investigator, would compromise the patient's ability to comply with the study or interfere with the evaluation of the safety and efficacy of the test drug.
  • Women who are pregnant, nursing, or who plan to become pregnant or nurse during the trial or within 6 months after the last dose of study treatment.
  • Active alcohol or drug abuse in the opinion of the investigator.
  • Patient unwilling or unable to comply with the protocol.
  • Presence or history of uncontrolled or symptomatic brain or subdural metastases, unless considered stable by the investigator and local therapy was completed. Inclusion of patients with newly identified brain metastasis/es at screening will be allowed if patients are asymptomatic.
  • Known history of human immunodeficiency virus (HIV) infection or an active hepatitis B or C infection which in the opinion of the investigator may interfere with participation in the trial.
  • History of severe hypersensitivity reactions to monoclonal antibodies.
  • History of allergy to kanamycin or similar class drugs (including streptomycin, gentamicin, amikacin, tobramycin and neomycin).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan,   Netherlands,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03604445
Other Study ID Numbers  ICMJE 1401-0001
2017-002945-31 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description:

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:

  1. studies in products where Boehringer Ingelheim is not the license holder;
  2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials;
  3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).

For more details refer to: https://www.mystudywindow.com/msw/datasharing

Current Responsible Party Boehringer Ingelheim
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Boehringer Ingelheim
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Boehringer Ingelheim
Verification Date August 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP