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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)

NCT03604445

Description:

The primary objective of this trial is to determine the maximum tolerated dose (MTD) of BI 905677 given as an intravenous infusion and to determine the recommended dose and dosing schedule for further trials in the development of BI 905677. The MTD will be defined based on the frequency of patients experiencing Dose Limiting Toxicity (DLT)s during the MTD evaluation period, which is defined as the first cycle of treatment. Separate MTDs will be determined for dosing Schedule A and dosing Schedule B. Recruitment into Schedule B will start after the MTD of Schedule A is reached. The secondary objective of the trial is: - To determine the pharmacokinetic profile of BI 905677

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: 1401-0001
  • SECONDARY ID: 2017-002945-31
  • NCT ID: NCT03604445

Conditions

  • Neoplasms

Interventions

DrugSynonymsArms
BI 905677BI 905677

Purpose

The primary objective of this trial is to determine the maximum tolerated dose (MTD) of BI 905677 given as an intravenous infusion and to determine the recommended dose and dosing schedule for further trials in the development of BI 905677. The MTD will be defined based on the frequency of patients experiencing Dose Limiting Toxicity (DLT)s during the MTD evaluation period, which is defined as the first cycle of treatment. Separate MTDs will be determined for dosing Schedule A and dosing Schedule B. Recruitment into Schedule B will start after the MTD of Schedule A is reached. The secondary objective of the trial is: - To determine the pharmacokinetic profile of BI 905677

Trial Arms

NameTypeDescriptionInterventions
BI 905677ExperimentalSchedule 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.
  • BI 905677

Eligibility Criteria

        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).
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Maximum tolerated dose (MTD) of BI 905677
Time Frame:Up to 4 weeks
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Cmax: maximum measured concentration of BI 905677 in serum after first infusion
Time Frame:24 hours
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Boehringer Ingelheim

Last Updated

November 11, 2019