A Study to Find the Best Dose of BI 905711 in Combination With Chemotherapy and to Test Whether This Dose Helps People With Advanced Gastrointestinal Cancers

  • STATUS
    Recruiting
  • End date
    Nov 5, 2024
  • participants needed
    100
  • sponsor
    Boehringer Ingelheim
Updated on 27 June 2022

Summary

This study is open to adults with advanced colorectal cancer or with advanced pancreatic cancer. The study has 2 parts. In the first part, participants with colorectal cancer get a medicine called BI 905711 combined with chemotherapy and bevacizumab. The purpose of the first part is to find the highest BI 905711 dose participants can tolerate. In the second part, participants with colorectal cancer or pancreatic cancer get BI 905711 combined with chemotherapy. Some participants also get bevacizumab. The second part tests whether BI 905711 makes tumours shrink. Participants get BI 905711, chemotherapy and bevacizumab about every 2 weeks as an infusion into a vein. Participants can stay in the study as long as they benefit from treatment and can tolerate it. The doctors regularly check the health of the participants and note any health problems that could have been caused by the study treatment. The doctors also monitor the size of the tumour.

Details
Condition Gastrointestinal Cancer, Metastatic
Treatment bevacizumab, FOLFIRI, BI 905711
Clinical Study IdentifierNCT05087992
SponsorBoehringer Ingelheim
Last Modified on27 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Signed and dated written informed consent in accordance with International Council of Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
Of legal adult age (according to local legislation) at screening
Histologically or cytologically confirmed, advanced unresectable or metastatic colorectal adenocarcinoma
Colorectal adenocarcinoma (CRC): Patients who have Progressive disease (PD) after prior oxaliplatin-based first line therapy or within 6 months after the end of oxaliplatin-based adjuvant therapy
Eastern Cooperative Oncology Group (ECOG) performance status ≤1
Life expectancy ≥ 3 months in the opinion of the investigator
Availability and willingness to provide tumor tissue (fresh biopsy or archival) for biomarker analysis. 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, the recruitment of the patient may proceed on a case-by-case basis after agreement between the investigator and BI. In such a case, an archived tumor tissue specimen must be submitted
Adequate hepatic, pancreatic, renal and bone marrow functions as defined by all of the
below
Total bilirubin ≤ 1.5 x institutional upper level of normal (ULN)
Alanine transaminase (ALT) and Aspartate transaminase (AST) ≤ 2.5 x institutional ULN or ≤ 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 (≥ 0.05L/min) (measured or calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula or Japanese version of CKD-EPI formula for Japanese patients)
Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L, ≥ 1.5 x 10^3/µL, or ≥ 1500/mm^3
Platelets ≥ 100 x 10^9/L, ≥ 100 x 10^3/µL, or ≥ 100 x 10^3/mm^3
Hemoglobin (Hb) ≥ 8.5 g/dl, ≥ 85 g/L, or ≥ 5.3 mmol/L (without transfusion within previous week)
Serum lipase ≤ 1.5 institutional ULN Further inclusion criteria apply

Exclusion Criteria

Any prior irinotecan-based therapy in the metastatic setting
Previous systemic anti-cancer therapy within the specified timeframe from the last dose intake to the first dose of trial treatment as follows
Any non-investigational drug, including anti-angiogenic agents (bevacizumab or ramucirumab or aflibercept) and anti-EGFR antibodies (cetuximab or panitumumab), within 14 days
Any investigational drug or other antibodies including immune checkpoint inhibitors, within 28 days
Currently enrolled in another investigational device or drug trial. Patients who are
in follow-up/observation for another clinical trial are eligible
Radiation therapy within 4 weeks prior to start of treatment. However, palliative radiotherapy for symptomatic metastasis is allowed if completed within 2 weeks prior to start of treatment
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
Known history of human immunodeficiency virus (HIV) infection
other serious GI pathological conditions by judgment of the investigator e.g. autoimmune disease with GI involvement, unexplained active diarrhea CTCAE v5.0 grade ≥ 2
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 hepatitis B virus deoxyribonucleic acid (HBV-DNA)
Presence of hepatitis C ribonucleic acid (RNA) Further exclusion criteria
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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