Advanced solid tumor malignancies
Conditions
Interventions
In Part A, (BT8009 monotherapy) participants will receive either 5 mg/m2 (Arm 1) once weekly (i.e., on Days 1, 8, and 15,) or 6 mg/m2 (Arm 2) on Days 1 and 8 of a 21-day cycle.
In Part B (BT8009 + Pe
Sponsors
Josephs Kate
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Eastern Cooperative Oncology Group (ECOG) of 0 or 1 2. Measurable disease as defined by RECIST v1.1 3. Life expectancy >-12 weeks after the start of BT8009 treatment. 4. Must have exhausted all standard treatment options, including appropriate targeted therapies; patients for which no standard therapy is considered appropriate or to provide clinical benefit, as assessed by the Investigator. Patient must have recurred after or been refractory to most recent prior therapy. 5. Patients with advanced, histologically confirmed the following solid tumor: a. urothelial (transitional cell) carcinoma; or b. pancreatic, breast, NSCLC, gastric, esophageal, head and neck, or ovarian tumors
Exclusion criteria
Exclusion criteria: 1. Current treatment with strong inhibitors or strong inducers of CYP3A or inhibitors of P- gp including herbal- or food-based. 2. Known hypersensitivity to any of the ingredients of the investigational product(s), including MMAE. 3. Active keratitis or corneal ulcerations. 4. Grade >-2 peripheral neuropathy. 5. Uncontrolled diabetes, defined as hemoglobin A1C (HbA1c) >-8% 6. Patients who are pregnant (including those who have been determined to be possibly pregnant based on e.g. a physician's interview) and/or lactating (not allowed to be enrolled even after discontinuation of breastfeeding) 7. Patients with uncontrolled hypertension (systolic blood pressure [BP] Systolic BP >-140 mm Hg or diastolic BP >-90 mm Hg) prior to first dose of BT8009 8. Prior Stevens-Johnson syndrome (SJS)/ toxic epidermal necrolysis (TEN) on any MMAE-conjugated drug 9. Active interstitial lung disease or pneumonitis, or a history of interstitial lung disease or pneumonitis requiring treatment with steroids or other immunosuppressive medications Exclusion Criteria Specific to Part B: Combination with pembrolizumab 10. Prior intolerance or known hypersensitivity to immune checkpoint inhibitor 11. Prior treatment with stimulatory or co-inhibitory T-cell receptor agents, such as CD137 agonists, OX-40 agonist or CTLA-4 inhibitors a. Prior treatment with a PD-1, PD-L1 or PD-L2 inhibitor is permitted
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Adverse Events as characterized by type, frequency, severity (as graded by CTCAE version 5.0), seriousness, and relationship to BT8009 and/or pembrolizumab. - Laboratory abnormalities as characterized by type, frequency, severity (as graded by CTCAE version 5.0). - Number of drug-related Adverse Events during safety evaluation period. - PK parameters of BT8009 and MMAE as monotherapy and in combination with pembrolizumab, such as maximum concentration (Cmax), area under the curve (AUC), and half-life (t1/2). | — |
Contacts
Public ContactYo Hara
CMIC Co.,Ltd.
Outcome results
None listed