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A Study in People With Advanced Cancer to Test How Well Different Doses of BI 770371 Alone or in Combination With Ezabenlimab Are Tolerated

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT05327946
Recruitment Status : Recruiting
First Posted : April 14, 2022
Last Update Posted : May 31, 2023
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:

This study is open to adults with advanced cancer (solid tumours). People for whom previous treatment was not successful and for whom no other treatment options exist can join the study.

The purpose of this study is to find the highest dose of BI 770371 that people with advanced cancer can tolerate when taken alone or together with a medicine called ezabenlimab.

BI 770371 and ezabenlimab are antibodies that may help the immune system fight cancer (checkpoint inhibitors). In this study, BI 770371 is given to people for the first time.

Participants get BI 770371 alone or together with ezabenlimab as an infusion every 3 weeks.

It is planned that participants can stay in the study for up to 2 years, if they benefit from treatment and can tolerate it. During this time, they visit the study site regularly.

The doctors collect information on any health problems of the participants. The doctors also regularly monitor the size of the tumour.

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: BI 770371 Drug: ezabenlimab Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Phase I Dose Escalation Followed by Dose Expansion Trial in Patients With Advanced Solid Tumours to Investigate Safety, Pharmacokinetics, and Efficacy and to Select the Dose for Further Development of BI 770371 in Combination With Ezabenlimab
Actual Study Start Date : May 9, 2022
Estimated Primary Completion Date : March 3, 2025
Estimated Study Completion Date : November 18, 2025

Arm Intervention/treatment
Experimental: Monotherapy dose escalation Drug: BI 770371
BI 770371

Experimental: Combination therapy dose escalation Drug: BI 770371
BI 770371

Drug: ezabenlimab

Primary Outcome Measures :
  1. Occurrence of Dose Limiting Toxicities (DLTs) in the Maximum Tolerated Dose (MTD) evaluation period in monotherapy [ Time Frame: 21 days ]
  2. Occurrence of Dose Limiting Toxicities (DLTs) in the Maximum Tolerated Dose (MTD) evaluation period in combination therapy [ Time Frame: 21 days ]

Secondary Outcome Measures :
  1. Occurrence of Adverse Events (AEs) during the on-treatment period in monotherapy [ Time Frame: up to 2 years ]
  2. Occurrence of Adverse Events (AEs) during the on-treatment period in combination therapy [ Time Frame: up to 2 years ]
  3. Occurrence of Dose Limiting Toxicities (DLTs) during the on-treatment period in monotherapy [ Time Frame: up to 2 years ]
  4. Occurrence of Dose Limiting Toxicities (DLTs) during the on-treatment period in combination therapy [ Time Frame: up to 2 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Signed and dated written informed consent form (ICF) in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
  • Patients ≥18 years of age and over the legal age of consent as required by local legislation at the time of signature of the ICF
  • Presence of at least one measurable lesion according to Response Evaluation Criteria In Solid Tumours (RECIST) v1.1
  • Eastern Cooperative Oncology Group (ECOG) Score: 0 to 1
  • Life expectancy ≥3 months at the start of treatment in the opinion of the Investigator.
  • Patients with a confirmed diagnosis of advanced, unresectable, and/or metastatic solid tumours (any type)
  • Patients who have failed conventional treatment or for whom no therapy of proven efficacy exists or who are not eligible for established treatment options (including anti-Programmed Cell Death 1 (PD-1) or anti-Programmed Death-Ligand 1 (PD-L1) therapies, if relevant). Patients must have exhausted available treatment options known to prolong survival for their disease
  • All toxicities related to previous anti-cancer therapies have resolved ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 prior to trial treatment administration (except for alopecia, peripheral neuropathy and endocrinopathies considered irreversible [like hypothyroidism], and amenorrhea/menstrual disorders which can be any grade) Further inclusion criteria apply

Exclusion Criteria:

  • Major surgery (major according to the Investigator's assessment) performed within 12 weeks prior to randomisation or planned within 12 months after screening, e.g. hip replacement
  • Presence of active invasive cancers other than the one treated in this trial within 5 years prior to screening, with the exception of appropriately treated basal-cell carcinoma of the skin, in situ carcinoma of the uterine cervix, or other local tumours considered cured by local treatment
  • Untreated brain metastasis(es) that may be considered active. Patients with previously treated brain metastases may participate provided they are stable (i.e., without evidence of Progressive Disease (PD) by imaging for at least 4 weeks prior to the first dose of trial treatment, and any neurologic symptoms have returned to baseline), and there is no evidence of new or enlarging brain metastases
  • Radiotherapy within 4 weeks prior to randomisation except as follows:

    • Palliative radiotherapy to regions other than the chest is allowed if completed at least 2 weeks prior to randomisation
    • Single dose palliative radiotherapy for symptomatic metastasis within 2 weeks prior to randomisation may be allowed but must be discussed with the Sponsor
  • 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
  • History of pneumonitis within the last 5 years or Interstitial lung disease
  • Known history of allergy to any trial drug, or any excipients of the trial drug(s)
  • History of severe hypersensitivity reactions and/or severe infusion related reactions (Grade ≥ 3 National Cancer Institute (NCI) CTCAE v5.0) to other Monoclonal Antibodies (mAbs) Further exclusion criteria apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT05327946

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Contact: Boehringer Ingelheim 1-800-243-0127

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United States, Florida
Florida Cancer Specialists Recruiting
Sarasota, Florida, United States, 34232
Contact: Boehringer Ingelheim    833-602-2368   
United States, New Jersey
John Theurer Cancer Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Boehringer Ingelheim    833-602-2368   
Canada, Quebec
Centre Hospitalier de l'Universite de Montreal (CHUM) Recruiting
Montreal, Quebec, Canada, H2X 0A9
Contact: Boehringer Ingelheim    18336022346   
National Cancer Center Hospital East Recruiting
Chiba, Kashiwa, Japan, 277-8577
Contact: Boehringer Ingelheim    0120201230   
National Cancer Center Hospital Recruiting
Tokyo, Chuo-ku, Japan, 104-0045
Contact: Boehringer Ingelheim    0120201230   
Sponsors and Collaborators
Boehringer Ingelheim
Additional Information:
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Responsible Party: Boehringer Ingelheim Identifier: NCT05327946    
Other Study ID Numbers: 1501-0001
First Posted: April 14, 2022    Key Record Dates
Last Update Posted: May 31, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
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. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to:

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No