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Monoclonal Antibodies

DCBY02 for Solid Tumors

Phase 1
Waitlist Available
Led By Michael Gordon, MD
Research Sponsored by DynamiCure Biotechnology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female patients of childbearing potential must have a negative serum beta-human chorionic gonadotropin (β-hCG) pregnancy test at Screening and agree to use highly effective contraception.
Patients with unresectable or metastatic solid tumors, except for patients with GBM, must have a lesion that can be biopsied with acceptable clinical risk and agree to have a fresh biopsy at Screening and an on-treatment biopsy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is testing two different types of monotherapy (single treatment) for advanced or metastatic solid tumors. Part A is testing compound DCBY02 while Part B is testing compound DCSZ11 (which is not yet active).

Who is the study for?
Adults with advanced or metastatic solid tumors who have tried all other treatments without success are eligible. They must be able to undergo a biopsy, have at least one measurable tumor lesion, and be in fair health as judged by ECOG standards. Women of childbearing age and men must agree to use contraception.Check my eligibility
What is being tested?
The trial is testing DCBY02, an anti-CD93 monoclonal antibody, on its own to see how it affects patients with various types of incurable solid tumors that have spread. It's an early-phase study where everyone gets the same treatment.See study design
What are the potential side effects?
Specific side effects for DCBY02 aren't listed but may include typical reactions related to monoclonal antibodies such as infusion-related reactions, fatigue, allergic responses or organ-specific inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not pregnant and agree to use effective birth control.
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I agree to have two biopsies for my cancer, which is not brain cancer (GBM), and it's safe to do so.
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I can take care of myself and am up and about more than half of my waking hours.
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I am a man who will not have children and will use birth control or abstain from sex.
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My cancer is incurable or has spread and may benefit from specific immune therapy.
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My cancer has worsened despite treatment, and I can't tolerate or have failed all known effective therapies.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Frequency and severity of treatment-emergent adverse events (TEAEs)
Incidence of DLTs occurring in the first 28 days following DCBY02 administration
Secondary outcome measures
Disease control rate (DCR) as determined per Investigator assessment
Duration of response (DOR) as determined per Investigator assessment
Objective response rate (ORR) as determined per Investigator assessment
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Part 2: Dose ExpansionExperimental Treatment1 Intervention
Dose expansion to further investigate safety, tolerability, and preliminary evidence of antitumor activity and characterize PK and PD of DCBY02.
Group II: Part 1: Dose EscalationExperimental Treatment1 Intervention
Dose escalation to investigate safety, tolerability, and determine recommended phase 2 dose (RP2D) for DCBY02.

Find a Location

Who is running the clinical trial?

DynamiCure BiotechnologyLead Sponsor
1 Previous Clinical Trials
257 Total Patients Enrolled
Michael Gordon, MDPrincipal InvestigatorHonorHealth Research Institute
4 Previous Clinical Trials
167 Total Patients Enrolled
Christopher Lieu, MDPrincipal InvestigatorUniversity of Colorado, Denver
3 Previous Clinical Trials
157 Total Patients Enrolled

Media Library

DCBY02 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05496595 — Phase 1
Solid Tumors Research Study Groups: Part 1: Dose Escalation, Part 2: Dose Expansion
Solid Tumors Clinical Trial 2023: DCBY02 Highlights & Side Effects. Trial Name: NCT05496595 — Phase 1
DCBY02 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05496595 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research team currently recruiting participants?

"According to the records available on clinicaltrials.gov, this medical study is actively recruiting participants. It was initially published on October 26th 2022 and its details were most recently refreshed November 7th of that same year."

Answered by AI

How many participants will be part of this research endeavor?

"Affirmative. According to info found on clinicaltrials.gov, this study is actively recruiting participants since October 26th 2022 and the last update was made in November 7th 2022. This trial requires 96 individuals from one centre for participation."

Answered by AI

Could you elaborate on the potential risks associated with Part 1A Dose Escalation?

"There is limited safety and efficacy data in regards to Part 1A Dose Escalation, so it has been allotted a value of 1 on the risk spectrum."

Answered by AI
~2 spots leftby Mar 2025