Solid Tumor (Phase I)
Conditions
Brief summary
The Phase 1 clinical study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of BD200 in adult participants with advanced solid cancers. This is an open-label study consisting of two-parts: Part A Dose Escalation and Part B Dose Expansion. At least one tumor-specific cohort will be selected in Part B Dose Expansion.
Interventions
DRUGBD200
Infusion
Sponsors
Biolojic Design Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18+ years * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Participant willing to provide tumor biopsies * Measurable disease per RECIST v1.1 * Histologically-confirmed advanced, metastatic, or recurrent solid tumors that is not amenable to surgical resection or other approved therapeutic options * Satisfy requirements for prior treatments per tumor type as outlined in the protocol * Adequate organ function * Agree to contraception requirements as outlined in the protocol
Exclusion criteria
* Any major surgery or traumatic injury prior to enrollment * Unhealed wounds from surgery or injury * Received other therapies within 4 weeks prior to enrollment * Any clinically significant chronic gastrointestinal (GI) disorder * Any clinically significant ascites or liver disease * Any clinically significant pulmonary compromise * Active infection at the time enrollment * Active autoimmune disease * History or active skin disease requiring frequent treatment * Any clinically significant corneal disorder * Active known second malignancy * Any clinically significant cardiac disease * Participants with tumor abutting or eroding a major vessel * Pregnant or lactating or planning to become pregnant * Known hypersensitivity to BD200 or any of its ingredients * Unresolved toxicities from previous anticancer therapy * Participation in a concurrent clinical study in the treatment period * Part A Only: Participant with hepatitis B virus (HBV), hepatitis virus (HCV) or human immunodeficiency virus (HIV) infection Note: Other inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1 Part A | Cycle 1 Day 1 through Cycle 1 Day 21 [approximately 21 days] | Number of Participants with Dose Limiting Toxicities (DLTs) |
| Phase 1 Part A & Part B | Cycle 1 Day 1 through End of Treatment (EOT) (until no longer receives clinical benefit, has unacceptable toxicity and meets protocol-defined discontinuation criteria as assessed by Investigator/Sponsor [approximately 12 months] | Number of Participants with Treatment-emergent Adverse Events (TEAEs) and AEs Leading to Dose Reduction, Dose Interruption, and Dose Discontinuation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1 Part A & Part B | Cycle 1 Day 1 through EOT (until participant is no longer receiving clinical benefit, has unacceptable toxicity, and meets protocol-defined discontinuation criteria as assessed by Investigator/Sponsor [up to approximately 12 months]) | Area Under the Concentration Time Curve (AUC) of BD200 |
| Phase 1 Part A | Cycle 1 Day 1 through End of Treatment (EOT) (until no longer receives clinical benefit, has unacceptable toxicity and meets protocol-defined discontinuation criteria as assessed by Investigator/Sponsor [up to approximately 12 months] | ORR per RECIST Version 1.1 as Assessed by Investigator |
| Phase 1 Part B | Cycle 1 Day 1 through EOT [up to approximately 12 months] | IHC biopsy data of Trop-2 and Nectin 4 Expression |
Contacts
CONTACTBiolojic Design, Ltd.
Outcome results
None listed