Is NCT07607678 recruiting in New York, NY?

Yes, NCT07607678 is currently recruiting participants at its New York, NY location. This advanced solid cancer clinical trial is actively enrolling qualified participants.

How do I join the advanced solid cancer clinical trial in New York?

To join this clinical trial in New York, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this New York clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Advanced Solid Cancer Clinical Trial in New York, NY

About This Advanced Solid Cancer Study in New York

This study is open to adults with advanced cancer. The purpose of this study is to find the highest dose of BI 3819026 that people with advanced cancer can tolerate when taken alone and together with ezabenlimab. BI 3819026 and ezabenlimab are study medicines that may fight cancer. Participants first receive one treatment of BI 3819026 alone, followed by treatment with a combination of BI 3819026 and ezabenlimab. Different doses of BI3819026 are given to small groups of participants, starting with the lowest dose. Treatment with the next higher dose of BI 3819026 starts only if the previous dose was tolerated. Each participant remains on the same dose of BI 3819026 throughout the study. Participants are in the study for up to 2 years as long as they can tolerate the treatment and their condition does not get worse. During this time, they visit the study site regularly. The doctors look at the occurrence of certain health problems. They also regularly take blood samples, image participants' tumours, and take note of any unwanted effects.

Sponsor: Boehringer Ingelheim

Who Can Participate

Inclusion Criteria

Participants with histologically confirmed unresectable advanced or metastatic solid tumours who have documented progression after or are refractory to or ineligible for established and available therapies with proven clinical benefit, or have declined such therapy.

At least one measurable disease lesion outside of the central nervous system (CNS) defined per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1

Patients with brain metastases are eligible provided they meet the following criteria:

Brain metastases have adequately been treated and are without progression or haemorrhage and are considered stable and asymptomatic by the investigator,

Radiotherapy and/or surgery for brain metastases was completed at least 14 and 28 days, respectively, prior to the first administration of BI 3819026,

Patient is off steroids and anti-convulsive drugs for at least 7 days prior to the first administration of BI 3819026 and has no requirement for such therapy at the time of initiating trial treatment.

Availability of archived formalin-fixed and paraffin embedded (FFPE) tumour tissue. Patients who do not have archived FFPE tumour tissue available may be allowed to enrol without archival tumour tissue upon agreement between the investigator and the Sponsor

All toxicities related to previous anti-cancer therapies have resolved to Grade ≤1 or baseline 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)

Adequate liver, bone marrow and renal organ function Further inclusion criteria apply.

Exclusion Criteria

Previous or concomitant malignancies other than the one treated in this trial within the last 3 years except:

Effectively treated non-melanoma skin cancers

Effectively treated carcinoma in situ of the cervix

Effectively treated ductal carcinoma in situ of the breast

Other effectively treated malignancy that is considered cured by local treatment

Has received prior therapy with an immune-checkpoint inhibitor that was discontinued due to immune-related adverse events (AE)

Prior treatment with systemic anti-cancer drugs (including any agents or investigational medicinal products) within 3 weeks or 5 half-lives (whichever is shorter) before the first dose of trial treatment

Radiotherapy within 4 weeks prior to start of the trial treatment except as follows:

Palliative radiotherapy to regions other than the chest is allowed if completed at least 2 weeks prior and is not on the target lesion (which should be outside of the radiation field)

Single dose palliative radiotherapy for symptomatic metastasis that is not the target lesion (which should be outside of the radiation field) within 2 weeks prior may be allowed

Active/previous history of interstitial lung disease, pulmonary fibrosis, organising pneumonia or non-infectious pneumonitis (any grade)

Patients with active autoimmune disease or a documented history of autoimmune disease, that requires systemic treatment, e.g. corticosteroids or immunosuppressive drugs, except patients with vitiligo, resolved childhood asthma/atopy, alopecia, or any chronic skin condition that does not require systemic therapy; patients with autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone and/or controlled Type 1 diabetes mellitus on a stable insulin regimen are eligible

Patient has a diagnosis of immunodeficiency other than human immunodeficiency virus (HIV)

Patients with history of HIV infection who meet one or more of the following criteria:

CD4+ count \<350 cells/µL

Viral load \>400 copies/mL

Not receiving antiretroviral therapy

Receiving established antiretroviral therapy for less than four weeks prior to the start of trial treatment

History of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within 12 months prior to start of trial treatment Patients with a history of HIV who do not meet any of the exclusion criteria above are eligible to participate but the patient must be under the care of an HIV/Infectious Diseases specialist, or an HIV/Infectious Diseases specialist must be consulted prior to inclusion Further exclusion criteria apply.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in New York?

Yes, this clinical trial (NCT07607678) has an active research site in New York, NY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Advanced Solid Cancer Treatment Options in New York, NY

If you're searching for advanced solid cancer treatment options in New York, NY, this clinical trial (NCT07607678) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our New York research site is actively enrolling participants for this clinical trial. You'll receive care from experienced advanced solid cancer specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all advanced solid cancer clinical trials near you to find additional studies recruiting in your area.

Advanced Solid Cancer Clinical Trial in New York, NY

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