DCBY02 as a Monotherapy in Patients With Advanced or Metastatic Solid Tumors

NCT05496595 | Terminated Phase 1 FDA Drug

• 1 other identifier: DCBY02-101
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 3

Brief Summary

Study DCBY02-101 is a multicenter, open-label, Phase 1 study to assess the effects of anti-CD93 mAb (DCBY02) as a monotherapy in patients with advanced or metastatic solid tumors.

Conditions

Advanced or Metastatic Solid Tumors

Outcome Measures

Primary Outcomes (2)

• Incidence of DLTs occurring in the first 28 days following DCBY02 administration

  2 years

• Frequency and severity of treatment-emergent adverse events (TEAEs)

  From first dose to Cycle 2 Day 8 (28 days)

Secondary Outcomes (11)

• Objective response rate (ORR) as determined per Investigator assessment

  1 year

• Duration of response (DOR) as determined per Investigator assessment

  1 year

• Disease control rate (DCR) as determined per Investigator assessment

  1 year

• Progression free survival (PFS) as determined per Investigator assessment

  1 year

• Overall survival (OS)

  1 year

Study Arms (2)

Part 1: Dose Escalation

EXPERIMENTAL

Dose escalation to investigate safety, tolerability, and determine recommended phase 2 dose (RP2D) for DCBY02.

Drug: DCBY02

Part 2: Dose Expansion

EXPERIMENTAL

Dose expansion to further investigate safety, tolerability, and preliminary evidence of antitumor activity and characterize PK and PD of DCBY02.

Drug: DCBY02

Interventions

DCBY02 DRUG

A monoclonal antibody that binds to CD93, DCBY02 will be administered as a single intravenous (IV) infusion on Day 1 in each 21-day cycle.

Part 1: Dose Escalation; Part 2: Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients ≥ 18 years of age.
• Histologically or cytologically confirmed incurable or metastatic solid tumors - colorectal, gastric, non-small cell lung, renal cell, breast, hepatocellular, ovarian, cervical cancer, GBM or with a potential benefit from PD-1/PD-L1 blockade where hypoxia is associated with resistance to PD-1 blockade eg, as reported for or head and neck cancer and is not amenable to curative treatment.
• The malignancy must have progressed after at least 1 available standard therapy for incurable disease, and the patient has failed or is intolerant to all available therapies known to be active for the malignancy and have meaningful impact on the disease.
• Male or female patients ≥18 years of age 2. Histologically or cytologically confirmed incurable or metastatic solid tumors (including but not limited to colorectal, gastric, non-small cell lung, renal cell, breast, hepatocellular, ovarian, cervical, or head and neck cancer; or GBM). The malignancy must have progressed after at least 1 available standard therapy for incurable disease, and the patient has failed or is intolerant to all available therapies known to be active for the malignancy and have a meaningful impact on the disease. The Investigator needs to discuss any available standard options with the patient and document the benefits and risks of all options along with the rationale for recommending the study.
• Note: For patients who are intolerant to or refuse standard of care therapy for recurrent disease, reasons must be documented.
• \. 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. Every effort must be made to take the second biopsy from the same lesion of the biopsy at Screening.
• A lesion in a previously irradiated area could be biopsied as long as there is objective evidence of progression of the lesion before study enrollment.
• \. Patients with solid tumors must have at least 1 measurable lesion according to RECIST 1.1 (non-nodal lesions must be ≥ 1.0 cm in the long axis or ≥ double the slice thickness in the long axis; nodal lesions must be ≥ 1.5 cm in the short axis).
• a) A lesion in a previously irradiated area is eligible to be considered as a measurable disease as long as there is objective evidence of progression of the lesion before study enrollment.
• b) In Cohort 1 and Cohort 2, patients without measurable lesions are eligible. c) Patients with GBM must meet the RANO criteria of measurable disease (10 mm × 10 mm) for the post-gadolinium primary tumor weighted images (T1WI) 5. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2. 6. Adequate organ function and bone marrow reserve as indicated by the following laboratory assessments performed within 14 days prior to the first dose of study drug:
• Bone marrow function: absolute neutrophil count (ANC) ≥ 1500/μL; hemoglobin ≥ 9 g/dL; platelet count ≥ 75,000/μL.
• Hepatic function: Total serum bilirubin ≤ 1.5 times the upper limit of normal (ULN); serum aspartate aminotransferase (AST)/alanine aminotransferase (ALT), ≤ 3× ULN (≤ 5 × ULN in the presence of hepatic metastases).
• Note: Patients with inherited disorders of bilirubin metabolism should be discussed with the Sponsor.
• c) Renal function: Creatinine clearance ≥ 30 mL/minute based on Cockcroft-Gault estimation.
• d) Coagulation profile: Prothrombin time (PT) - international normalized ratio (INR)/activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN. Patients on a stable, maintenance regimen of anticoagulant therapy for at least 30 days prior to the first dose of study drug may have PT/INR measurements \> 1.5 × ULN if, in the opinion of the Investigator, the patient is suitable for the study. An adequate rationale must be provided to the Sponsor prior to enrollment.

You may not qualify if:

• Note: Low-dose steroids (oral prednisone or equivalent ≤10 mg per day), hormonal therapy for prostate cancer or breast cancer (as adjuvant treatment), and treatment with bisphosphonates and receptor activator of nuclear factor kappa-Β ligand (RANKL) inhibitors are allowed.
• Patients with second malignancy within the previous 3 years, except treated basal cell or localized squamous skin carcinomas, localized prostate cancer, cervical carcinoma in situ, resected colorectal adenomatous polyps, breast cancer in situ, or other malignancy for which the patient is not on active anticancer therapy. These patients must be discussed with the medical monitor prior to enrollment.
• \. Patients with known active central nervous system (CNS) metastases. Patients with previously treated brain metastases may participate provided that:
• They are stable (i.e., without evidence of progression by magnetic resonance imaging \[MRI\]) for ≥ 4 weeks prior to the first dose of study drug),
• All neurologic symptoms have returned to Baseline, and
• They have no evidence of new or enlarging brain metastases.
• If signs or symptoms suggest CNS metastases, a brain MRI or CT scan must be performed to confirm the absence of detectable CNS disease within 2 weeks prior to the first dose of study drug.
• Note: The above criteria are not applicable to GBM patients. For GBM, patients may participate if they are on corticosteroids or on stable or decreasing corticosteroid levels exceeding 2 mg/day dexamethasone (or equivalent doses of other steroids) during the last 3 days prior to enrollment, expectation that the patient will need corticosteroid doses \> 2 mg/dexamethasone/day or equivalent during the next 3 months.
• \. New York Heart Association Class III or IV heart disease, active ischemia, or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia requiring therapy, uncontrolled hypertension, or congestive heart failure within the last 3 months.
• \. Patients with systemic arterial thrombotic or embolic events, such as cerebrovascular accident (including ischemic attacks) or hemoptysis within 3 months prior to the first dose of study drug.
• \. Patients with systemic venous thrombotic events (e.g., deep vein thrombosis) or pulmonary arterial events (e.g., pulmonary embolism) within 1 month prior to the start of study drug.
• \. Left ventricular ejection fraction (LVEF) \< 50% or below the lower limit for normal institutional level.
• \. Major surgery within 4 weeks and minor surgery within 2 weeks of the first dose of study drug; following surgeries, all surgical wounds must be healed and free of infection or dehiscence.
• \. Patients with marked proteinuria ≥ 2 g/24 hours and/or nephrotic syndrome. Patients with proteinuria 2+ or greater urine dipstick reading should undergo further assessment, e.g., a 24-hour urine collection.
• \. Any other clinically significant comorbidities, such as uncontrolled pulmonary disease, active infection, or any other condition, which in the judgment of the Investigator, could compromise compliance with the protocol, interfere with the interpretation of study results, or predispose the patient to safety risks.

Sponsors & Collaborators

• DynamiCure Biotechnology: lead

Study Sites (3)

Honor Health

Scottsdale, Arizona, 85258, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: August 11, 2022
• Study Start: October 26, 2022
• Primary Completion: February 5, 2024
• Study Completion: February 5, 2024
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)