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

NCT03604445 | Terminated Phase 1 Results FDA Drug

• 2 other identifiers: 1401-00012017-002945-31
• Study Type: interventional
• Target: 37
• Locations: 4 countries
• Sites: 5

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.

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Dose Limiting Toxicities (DLTs)

  The number of participants with Dose Limiting Toxicities (DLTs) is reported. Any of the following adverse events (AEs) will be classified as DLTs following review by the Safety Monitoring Committee and the Medical Monitor, unless unequivocally due to underlying malignancy or an extraneous cause, including any AE which prevents a patient starting Cycle 2 within 14 days of completion of Cycle 1; Bone mineral density change of \>5% from baseline, confirmed at least 2 months after initial observation; β-CTX increase of more than two-fold from baseline; Grade 3 osteoporosis, and so on.

  In the first treatment cycle, up to 3 weeks

• Number of Patients Experiencing Adverse Events (AEs) During the Entire Treatment Period

  The Number of patients experiencing adverse events (AEs) during the entire treatment period is reported.

  From first dose until last dose + 42 days (6 weeks) of residual effect period, up to 36 weeks.

Secondary Outcomes (2)

• Maximum Measured Concentration of BI 905677 in Serum After First Infusion (Cmax)

  5 minutes (min) before and at 1, 1.5, 4, 8, 24, 72, 168 and 336 hour(s) after first dosing in Cycle 1.

• Area Under the Serum Concentration-time Curve Over the Time Interval From 0 to the Last Measured Time Point (AUC0-tz)

  5 minutes (min) before and at 1 1.5, 4, 8, 24, 72, 168 and 336 hour(s) after first dosing in Cycle 1.

Study Arms (9)

BI 905677 0.05 mg/kg

EXPERIMENTAL

0.05 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 were administered intravenously on Day 1 of each 3-week treatment cycle. Patients may continue on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment are met.

Drug: BI 905677

BI 905677 0.1 mg/kg

EXPERIMENTAL

0.1 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 were administered intravenously on Day 1 of each 3-week treatment cycle. Patients may continue on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment are met.

Drug: BI 905677

BI 905677 0.2 mg/kg

EXPERIMENTAL

0.2 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 were administered intravenously on Day 1 of each 3-week treatment cycle. Patients may continue on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment are met.

Drug: BI 905677

BI 905677 0.4 mg/kg

EXPERIMENTAL

0.4 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 were administered intravenously on Day 1 of each 3-week treatment cycle. Patients may continue on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment are met.

Drug: BI 905677

BI 905677 0.8 mg/kg

EXPERIMENTAL

0.8 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 were administered intravenously on Day 1 of each 3-week treatment cycle. Patients may continue on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment are met.

Drug: BI 905677

BI 905677 1.6 mg/kg

EXPERIMENTAL

1.6 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 were administered intravenously on Day 1 of each 3-week treatment cycle. Patients may continue on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment are met.

Drug: BI 905677

BI 905677 2.4 mg/kg

EXPERIMENTAL

2.4 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 were administered intravenously on Day 1 of each 3-week treatment cycle. Patients may continue on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment are met.

Drug: BI 905677

BI 905677 2.8 mg/kg

EXPERIMENTAL

2.8 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 were administered intravenously on Day 1 of each 3-week treatment cycle. Patients may continue on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment are met.

Drug: BI 905677

BI 905677 3.6 mg/kg

EXPERIMENTAL

3.6 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 were administered intravenously on Day 1 of each 3-week treatment cycle. Patients may continue on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment are met.

Drug: BI 905677

Interventions

BI 905677 DRUG

Solution for infusion

BI 905677 0.05 mg/kg; BI 905677 0.1 mg/kg; BI 905677 0.2 mg/kg; BI 905677 0.4 mg/kg; BI 905677 0.8 mg/kg; BI 905677 1.6 mg/kg; BI 905677 2.4 mg/kg; BI 905677 2.8 mg/kg; BI 905677 3.6 mg/kg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (5)

University of Southern California

Los Angeles, California, 90033, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

National Cancer Center Hospital East

Chiba, Kashiwa, 277-8577, Japan

Location

Erasmus MC Kanker Instituut

Rotterdam, 3015 CN, Netherlands

Location

Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

Related Links

• Related Info

MeSH Terms

Conditions

Neoplasms

Limitations and Caveats

Recruitment into Schedule B was planned start after the maximum tolerated dose of Schedule A was reached. Study was terminated prematurely due to sponsor decision before Schedule B starting. The planned Schedule B part was not held.

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

18002430127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2018
• First Posted: July 27, 2018
• Study Start: August 8, 2018
• Primary Completion: July 27, 2022
• Study Completion: July 27, 2022
• Last Updated: March 4, 2024
• Results First Posted: March 4, 2024

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); NL (1); US (2); JP (1)