Clinical trial · Interventional
This Clinical Study is to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and Preliminary Antitumor Activity of BD200 in Participants With Advanced or Metastatic Cancer.
A Phase 1a/b, First-in-Human Dose Escalation and Dose Expansion Clinical Study of the Dual Targeting Trop-2 and Nectin-4 Multibody Drug Conjugate BD200 in Participants With Select Unresectable Locally Advanced or Metastatic Cancers
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor (Phase I) | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BD200 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Part A Dose Escalation
- description
- Participants with advanced or metastatic solid tumors will receive BD200.
- interventionNames
- Drug: BD200
- type
- EXPERIMENTAL
- label
- Part B Dose Expansion
- description
- Participants with at least one tumor type will receive BD200.
- interventionNames
- Drug: BD200
Primary outcomes (4)
- measure
- Phase 1 Part A
- timeFrame
- Cycle 1 Day 1 through Cycle 1 Day 21 [approximately 21 days]
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 exclusion criteria may apply.
References
Publications (0)
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