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Part 2B Dose Expansion for Advanced or Metastatic Solid Tumors

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Advanced or Metastatic Solid TumorsDCBY02 (Part A) - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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).

Eligible Conditions
  • Advanced or Metastatic Solid Tumors

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
GSK3745417
1
RBS2418
1
S095029

Study Objectives

4 Primary · 22 Secondary · Reporting Duration: 2 years

1 year
Part 1A: Disease control rate (DCR) as determined per Investigator assessment
Part 1A: Duration of response (DOR) as determined per Investigator assessment
Part 1A: Objective response rate (ORR) as determined per Investigator assessment
Part 1A: Overall survival (OS)
Part 1A: Progression free survival (PFS) as determined per Investigator assessment
Parts 1A/1B: Disease control rate (DCR) as determined per Investigator assessment
Parts 1A/1B: Duration of response (DOR) as determined per Investigator assessment
Parts 1A/1B: Objective response rate (ORR) as determined per Investigator assessment
Parts 1A/1B: Overall survival (OS)
Parts 1A/1B: Progression free survival (PFS) as determined per Investigator assessment
2 years
Part 1A/1B and 2A/2B: Incidence and severity of adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Part 1A/2A: Incidence and severity of adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Part 1A/2A: Incidence of anti-drug antibody (ADA) and neutralizing antibodies (NAbs) against DCBY02
Part 1A/2A: Pharmacokinetic parameters of DCBY02: area under the concentration-time curve (AUC)
Part 1A/2A: Pharmacokinetic parameters of DCBY02: clearance (CL)
Part 1A/2A: Pharmacokinetic parameters of DCBY02: half-life (t1/2)
Part 1A/2A: Pharmacokinetic parameters of DCBY02: maximum observed concentration (Cmax)
Part 1A/2A: Pharmacokinetic parameters of DCBY02: volume of distribution (Vz)
Parts 1A/1B and 2A/2B: Incidence of anti-drug antibody (ADA) and neutralizing antibodies (NAbs) against DCBY02/DCSZ11
Parts 1A/1B and 2A/2B: Pharmacokinetic parameters of DCBY02/DCSZ11: area under the concentration-time curve (AUC)
Parts 1A/1B and 2A/2B: Pharmacokinetic parameters of DCBY02/DCSZ11: clearance (CL)
Parts 1A/1B and 2A/2B: Pharmacokinetic parameters of DCBY02/DCSZ11: half-life (t1/2)
Parts 1A/1B and 2A/2B: Pharmacokinetic parameters of DCBY02/DCSZ11: maximum observed concentration (Cmax)
Parts 1A/1B and 2A/2B: Pharmacokinetic parameters of DCBY02/DCSZ11: volume of distribution (Vz)
Day 28
Part 1A/1B: The proportion of patients experiencing dose limiting toxicity (DLT) events
Part 1A: The proportion of patients experiencing dose limiting toxicity (DLT) events

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
GSK3745417
1
RBS2418
1
S095029

Trial Design

4 Treatment Groups

Part 2B Dose Expansion
1 of 4
Part 1A Dose Escalation
1 of 4
Part 1B Dose Escalation
1 of 4
Part 2A Dose Expansion
1 of 4

Experimental Treatment

192 Total Participants · 4 Treatment Groups

Primary Treatment: Part 2B Dose Expansion · No Placebo Group · Phase 1

Part 2B Dose Expansion
Drug
Experimental Group · 1 Intervention: DCSZ11 (Part B) · Intervention Types: Drug
Part 1A Dose EscalationExperimental Group · 2 Interventions: DCBY02 (Part A), DCBY02 · Intervention Types: Drug, Drug
Part 1B Dose Escalation
Drug
Experimental Group · 1 Intervention: DCSZ11 (Part B) · Intervention Types: Drug
Part 2A Dose ExpansionExperimental Group · 2 Interventions: DCBY02 (Part A), DCBY02 · Intervention Types: Drug, Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

Who is running the clinical trial?

DynamiCure BiotechnologyLead Sponsor
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
Igor Puzanov, MDPrincipal InvestigatorRoswell Park Comprehensive Cancer Center
1 Previous Clinical Trials
2,000 Total Patients Enrolled
Stephen Hodi, MDPrincipal InvestigatorDana-Farber Cancer Institute
1 Previous Clinical Trials
60 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are at least 18 years of age regardless of gender.
You have a histologically or cytologically confirmed incurable or metastatic solid tumor, such as colorectal, gastric, non-small cell lung, renal cell, breast, hepatocellular ovarian and cervical cancer; GBM with potential benefit from PD-1/PD-L1 blockade where hypoxia is associated with resistance to PD-1 blockade (e.g., reported for head and neck cancer) and the tumor is not amenable to curative treatment.
The malignancy must have advanced despite receiving at least one standard therapeutic treatment for an incurable condition, and the patient has not been able to tolerate or benefit from all known active treatments with a meaningful effect on the disease.
Patients with inoperable or diffused solid tumors, other than GBM sufferers, must possess a lesion that can be biopsied safely and agree to have a new biopsy during the screening process and early on in Cycle 2.
Your measurable lesions meet the criteria of Response Evaluation Criteria in Solid Tumors Version 1.1 or higher.
You have an Eastern Cooperative Oncology Group performance status between 0 and 2.
You possess satisfactory organ function and marrow reserve, as demonstrated by laboratory tests taken within two weeks before the initial dose of medication.
Female patients of childbearing potential must demonstrate a negative β-hCG pregnancy test and commit to using an effective contraceptive method.
Men who are not surgically sterile must agree to either abstain from sexual intercourse or use contraception and forgo donating sperm.
The patient is cognizant and compliant with the protocol, having signed the requisite Informed Consent Form (ICF)
References

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