Clareo Health | A First-in-human Study to Learn How Safe the Study Treatment BAY2862789 is, to Find the Best Dose, How it Affects the Body, What Maximum Amount Can be Given, How it Moves Into, Through and Out of the Body, and How it Acts on Different Tumors in Participants With Advanced Solid Tumors
A First-in-human Study to Learn How Safe the Study Treatment BAY2862789 is, to Find the Best Dose, How it Affects the Body, What Maximum Amount Can be Given, How it Moves Into, Through and Out of the Body, and How it Acts on Different Tumors in Participants With Advanced Solid Tumors
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Capable of giving signed informed consent
Be ≥18 years of age on day of signing informed consent.
Have measurable disease per Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1) as assessed by the local site investigator.
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Participants with a histologically confirmed diagnosis of a solid tumor that have exhausted available treatments known to be beneficial for this tumor type or for whom these treatments are not acceptable and for whom this trial is a reasonable option for them, will be enrolled onto this study. Appropriate molecular profiling of tumors should have been performed according to local national guidelines prior to trial entry. Specifications for the different parts of the study are below:
\-- Dose escalation: All solid cancers, except primary central nervous system cancers.
Provision of archival tumor sample at baseline is mandatory for all participants in escalation, and expansion cohorts.
Participants must be willing to undergo mandatory paired biopsies of tumor (pre- and on- treatment).
Have adequate organ function.
Agree to use contraception during the treatment period and for at least 6 months after the last dose of study treatment.
You may not be if
Had an allogeneic tissue/solid organ transplant.
Previous therapy with a diacylglycerol kinase (DGK) inhibitor
Has received a prior therapeutic regimen containing an anti-programmed cell death protein 1 (anti-PD-1), anti-programmed death-ligand 1 (anti-PD-L1), or anti-programmed cell death 1 ligand 2 (anti PD-L2) agent or an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX 40, CD137) and was discontinued from that treatment regimen due to a Grade 3 or higher immune related adverse event (irAE) or any toxicity that was life-threatening.
Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks or 5 half-lives, whatever is shorter, prior to treatment. Growth factor treatments such as granulocyte colony-stimulating factor (G-CSF) must have been discontinued 4 weeks prior to entering the study.
Participants must have recovered from previous radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.
Participants cannot have had a blood transfusion within 2 weeks of starting therapy.
Has received a live vaccine within 30 days prior to the first dose of study drug.
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
Participants with new brain metastases on screening brain magnetic resonance imaging/computed tomography (MRI/CT).
Primary central nervous system malignancy or presence of leptomeningeal disease.
Participants with gastrointestinal conditions that may compromise oral absorption such as short bowel syndrome or active tumor-related bowel obstruction with ongoing symptoms compromising absorption over last 6 months.
Has an active autoimmune disease including inflammatory bowel disease that has required systemic treatment in past 2 years.
Current pneumonitis / interstitial lung disease.
Has an active infection requiring systemic therapy.
