A Study to Find a Suitable Dose of BI 1821736 and Test Whether it Helps People With Advanced Cancer

NCT05839600 | Terminated Phase 1 Results DMC FDA Drug

• 3 other identifiers: 1467-00012022-502125-17-00U1111-1291-2873
• Study Type: interventional
• Target: 10
• Locations: 4 countries
• Sites: 8

Brief Summary

This study is open to adults with advanced solid tumours. People with solid tumours for whom previous treatment was not successful or no treatment exists can take part. The purpose of this study is to find the highest dose of a medicine called BI 1821736 that people with advanced solid tumours can tolerate. BI 1821736 is a type of immunotherapy. It is a special virus that kills cancer cells and helps the immune system fight cancer. In this study, BI 1821736 is given to humans for the first time. Participants receive BI 1821736 as an infusion into a vein about every 3 weeks for up to 3 months. Study doctors regularly check the participants' health and monitor the tumours. The doctors also take note of any unwanted effects that could have been caused by BI 1821736.

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Occurrence of DLTs in the MTD Evaluation Period

  Occurrence of dose limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period is reported as count of participants with DLTs in the MTD evaluation period.

  First treatment cycle, i.e., 21 days.

Secondary Outcomes (2)

• Occurrence of DLTs During the On-treatment Period

  From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.

• Occurrence of AEs During the On-treatment Period

  From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.

Study Arms (2)

BI 1821736 low dose

EXPERIMENTAL

Participants received a low dose of BI 1821736 as an infusion into a vein about every 3 weeks for up to 3 months.

Drug: BI 1821736

BI 1821736 high dose

EXPERIMENTAL

Participants received a high dose of BI 1821736 as an infusion into a vein about every 3 weeks for up to 3 months.

Drug: BI 1821736

Interventions

BI 1821736 DRUG

Solution for infusion/injection

BI 1821736 high dose; BI 1821736 low dose

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed diagnosis of malignant tumor.
• Advanced, unresectable and/or metastatic or relapsed/refractory solid tumors.
• 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 available treatment options known to prolong survival for their disease.
• Has at least one tumoral lesion which is amenable to biopsy.
• Signed and dated, written informed consent form (ICF) in accordance with ICH-GCP and local legislation obtained prior to any trial-specific procedures, sampling, or analyses that are not part of normal standard of practice care.
• Eastern Cooperative Oncology Group score of 0 or 1.
• Adequate organ function or bone marrow reserve defined as demonstrated at screening by the following laboratory values:
• Absolute neutrophil count (ANC) ≥ 1.5 x 109/L (≥ 1.5 x 10\^3/μL)(≥ 1500/mm\^3); haemoglobin ≥ 90 g/L (≥ 9.0 g/dL)(≥ 5.6 mmol/L); platelets ≥ 100 x 10\^9/L (≥ 100 x 10\^3/μL)(≥ 100 x 10\^3/mm\^3) without the use of haematopoietic growth factors within 4 weeks of start of trial medication.
• Creatinine ≤ 1.5 times the upper limit of normal (ULN).
• Total bilirubin ≤ 1.5 times the ULN, except for patients with Gilbert's syndrome: total bilirubin ≤ 3 times ULN or direct bilirubin ≤ 1.5 times ULN.
• Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 times ULN if no demonstrable liver metastases, or otherwise ≤ 5 x ULN if transaminase elevation is attributable to liver metastases.
• Partial thromboplastin (PT) / activated partial thromboplastin time (aPTT) \<1.5 times ULN unless on a stable dose of an anticoagulant.
• All toxicities related to previous anti-cancer therapies have resolved to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 prior to trial treatment administration (except for alopecia and peripheral neuropathy which must be ≤ CTCAE Grade 2 and amenorrhea/menstrual disorders which can be any grade).

You may not qualify if:

• Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to start of study treatment.
• Previous treatment with Vesicular Stomatitis Virus (VSV)-based agents.
• Patients with brain metastases unless they have completed brain radiotherapy and are asymptomatic.
• Radiotherapy within 4 weeks prior to the start of study treatment, except in case of a brief course of palliative radiotherapy (e.g. for analgesic purpose or for lytic lesions at risk of fracture) which can then be completed within two weeks prior to start of study treatment.
• Note: No radiation must have been given to any lesions planned to be biopsied within 6 months of start of treatment.
• Prior (within 3 weeks of first dose) or concomitant use of systemic corticosteroids (\>10 mg daily prednisone or equivalent).
• Prior (within 3 weeks of first dose or less than 5 half-lives) or concomitant use of a medication or a condition considered a high risk for complications from biopsy as per the Investigator's judgement.
• Prior (within 3 weeks of first dose or less than 5 half-lives) or concomitant use of interferon, immunotherapy agents, or tamoxifen.
• Active infection requiring systemic therapy (antibacterial, antiviral, antiparasitic or antifungal therapy) at the start of treatment in the trial.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (8)

Yale Cancer Center

New Haven, Connecticut, 06511, United States

Location

NEXT Oncology-San Antonio-65273

San Antonio, Texas, 78229, United States

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

Hospital Quiron. I.C.U.

Barcelona, 08023, Spain

Location

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Instituto Valenciano de Oncología

Valencia, 46009, Spain

Location

Karolinska Universitetssjukhuset Stockholm

Stockholm, 17177, Sweden

Location

Related Links

• Related Info

Limitations and Caveats

Due to early termination, only 2 dose levels were investigated in the trial.

Results Point of Contact

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

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

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: April 21, 2023
• First Posted: May 3, 2023
• Study Start: June 7, 2023
• Primary Completion: April 10, 2025
• Study Completion: April 10, 2025
• Last Updated: May 22, 2026
• Results First Posted: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1); CA (1); US (2); ES (4)