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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.

ConditionSolid Tumor (Phase I)
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBiolojic Design Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • BD200

    Drug

    Infusion

  • BD200

    Drug

    Infusion

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: Part A Dose EscalationExperimental treatment 1 intervention
Group B: Part B Dose ExpansionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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]
2

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]
3

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])
4

Phase 1 Part A & Part B

Duration of Response (DOR) per 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]

Secondary outcomes

1

Phase 1 Part A & Part B

Area Under the Concentration Time Curve (AUC) of BD200

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])
2

Phase 1 Part A & Part B

Maximum Observed Plasma Concentration (Cmax) of BD200

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])
3

Phase 1 Part A & Part B

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

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 [up to approximately 12 months]
4

Phase 1 Part A

ORR per RECIST Version 1.1 as Assessed by Investigator

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 [up to approximately 12 months]

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Biolojic Design Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: