Bristol Myers Squibb has initiated two Phase I clinical trials evaluating novel investigational therapies for patients with advanced cancers. The studies, designated NCT05407675 and NCT06090539, represent the company's continued expansion into oncology research targeting both solid tumors and hematologic malignancies.
BMS-986408 Trial for Advanced Solid Tumors
The first study (NCT05407675) is evaluating the safety and tolerability of BMS-986408 in patients with advanced, unresectable or metastatic solid malignancies. The trial targets participants who have received, been refractory to, ineligible for, or intolerant of existing therapies known to provide clinical benefit for their condition.
Eligible participants must have histologically or cytologically confirmed solid malignancy of any histology that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. For patients with melanoma, documentation of mutation status for B-type Raf proto-oncogene (BRAF) and neuroblastoma ras viral oncogene homolog (NRAS) is required. All participants must have experienced radiographically documented progressive disease on or after their most recent therapy.
The study excludes patients with active, known or suspected autoimmune disease, as well as those requiring systemic treatment with corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose. Patients with current or recent gastrointestinal disease or surgery that could impact drug absorption are also excluded, along with those having untreated central nervous system metastases or leptomeningeal metastasis.
BMS-986458 Study for Relapsed/Refractory Lymphomas
The second trial (NCT06090539) is assessing BMS-986458 alone and in combination with anti-cancer agents in patients with relapsed/refractory non-Hodgkin lymphoma (R/R NHL). The study specifically targets diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) patients.
For relapsed/refractory DLBCL (de novo) and FL 3b, participants must have received at least two prior lines of therapy, including a first-line combination chemotherapy regimen containing rituximab, anthracycline, an alkylating agent, and steroids, plus at least one additional treatment. Patients with relapsed/refractory DLBCL (transformed lymphoma) must have received at least two prior lines of therapy administered after transformation.
Participants must have measurable disease defined by at least one FDG-avid lesion for FDG-avid disease and one bi-dimensionally measurable disease on cross-sectional imaging with at least one lesion greater than 1.5 cm in the transverse diameter.
Exclusion Criteria and Safety Considerations
Both studies maintain strict exclusion criteria to ensure patient safety. The lymphoma trial excludes participants with an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or higher, and those with prior CAR-T therapy, Cereblon-modulating drug treatment, or recent radiotherapy within 4 weeks. Patients who have undergone allogeneic stem cell transplant within 6 months or autologous stem cell transplant within 3 months are also excluded.
The trials exclude participants with any condition that places them at unacceptable risk, including significant acute or chronic medical illness, active or uncontrolled infection, or laboratory abnormalities. Known or suspected central nervous system involvement is also an exclusion criterion for the lymphoma study.
Patient Enrollment and Study Design
Both Phase I trials are designed to evaluate safety and tolerability as primary objectives. The studies require participants to be at least 18 years of age and follow specific pregnancy prevention plans. The trials represent Bristol Myers Squibb's commitment to developing new treatment options for patients with limited therapeutic alternatives in both solid tumor and hematologic malignancy settings.
