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.

Phase 1Not Yet RecruitingNCT07797907

Biolojic Design Ltd.110 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

110

Conditions

Solid Tumor (Phase I)

Interventions

BD200DRUG

Infusion

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Phase 1 Part A

Number of Participants with Dose Limiting Toxicities (DLTs)

Time frame: Cycle 1 Day 1 through Cycle 1 Day 21 [approximately 21 days]

Phase 1 Part A & Part B

Number of Participants with Treatment-emergent Adverse Events (TEAEs) and AEs Leading to Dose Reduction, Dose Interruption, and Dose Discontinuation

Time frame: 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]

Phase 1 Part A & Part B

Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Investigator

Time frame: 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])

Phase 1 Part A & Part B

Duration of Response (DOR) per RECIST Version 1.1 as Assessed by Investigator

Secondary Outcomes

Phase 1 Part A & Part B

Area Under the Concentration Time Curve (AUC) of BD200

Phase 1 Part A & Part B

Maximum Observed Plasma Concentration (Cmax) of BD200

Phase 1 Part A & Part B

Number of Participants with Anti-drug Antibodies (ADAs) in Blood

Phase 1 Part A

ORR per RECIST Version 1.1 as Assessed by Investigator

Phase 1 Part A

DOR per RECIST Version 1.1 as Assessed by Investigator

Phase 1 Part B

IHC biopsy data of Trop-2 and Nectin 4 Expression

Time frame: Cycle 1 Day 1 through EOT [up to approximately 12 months]

Phase 1 Part B

Progression Free Survival (PFS) per RECIST Version 1.1 as Assessed by Investigator

Phase 1 Part B

Overall Survival (OS)

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.

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts