Study BT5528-100 in Patients With Advanced Solid Tumors Associated With EphA2 Expression

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This clinical trial is evaluating a drug called BT5528 alone and in combination with nivolumab in participants with advanced solid tumors that are identified as positive for EphA2 expression. The main goals of this study are to:

• Find the recommended dose of BT5528 that can be given safely to participants alone and in combination with nivolumab

• Learn more about the side effects of BT5528

• Learn more about BT5528 therapy alone and in combination with nivolumab.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bicycle Tx Limited
• Treatments: Nivolumab

Criteria

General Inclusion:

• Written informed consent, according to local guidelines, signed and dated by the patient or by a legal guardian prior to the performance of any study-specific procedures, sampling or analyses

• Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1

• Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

• Acceptable renal, hepatic, hematologic and coagulation functions

• Negative pregnancy test for women of childbearing potential

• Male participants with female partners of childbearing potential and female participants of childbearing potential are required to follow highly effective contraception

• Availability of archived tumor samples or willingness to provide fresh tumor biopsy during screening for EphA2 assessment

Additional inclusion criteria for Phase I (dose escalation phase, with BT5528 alone or in combination with nivolumab):

• Metastatic recurrent histologically confirmed malignant solid tumors confirmed to have EphA2 tumor expression. Confirmation of EphA2 expression prior to enrollment is not required for participants with ovarian cancer and specific other individual tumor types.

• Exhausted all appropriate treatment options per local guidelines

Additional inclusion criteria for Phase II (dose expansion phase, with BT5528 alone or in combination with nivolumab):

• Participants with metastatic recurrent disease histologically confirmed to be adenocarcinoma subtype of NSCLC (adeno-NSCLC) or other tumor subtypes are eligible and must have exhausted all appropriate treatment options per local guidelines including progression on or after platinum-based chemotherapy and appropriate therapies for driver mutations (if applicable).

• Confirmed EphA2 tumor expression prior to enrollment, unless waived for specific tumor types

Exclusion criteria (all participants):

• Chemotherapy treatments within 14 days prior to first dose of study treatment, other anticancer treatments, treatment within 28 days or 5 half-lives, whichever is the shorter

• Experimental treatments within 4 weeks of first dose of BT5528

• Current treatment with strong inhibitors or inducers of CYP3A4 or strong inhibitors of P-gp

• Uncontrolled, symptomatic brain metastases

• Any condition, therapy or laboratory abnormality that might confound the results of the study, interfere with the patient's participation, or is not in the best interest of the patient to participate in the opinion of the investigator including but not limited to specific cardiovascular criteria

• Thromboembolic events and/or bleeding disorders 3 months (e.g., deep vein thrombosis [DVT] or pulmonary embolism [PE]) prior to first dose

Additional Exclusion Criteria (BT5528 in combination with nivolumab):

• Prior organ transplant (including allogeneic)

• Diagnosis of clinically relevant immunodeficiency

• Active systemic infection requiring therapy

• More than 10 mg daily prednisone equivalent or other strong immunosuppressant

• History of autoimmune disease except alopecia or vitiligo

• History of interstitial lung disease