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

• Status: Not yet recruiting
• Trial end date: 2024-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Study DC-6001-101 is a multicenter, open-label, Phase 1 study to assess the effects of anti-CD93 mAbs as a monotherapy in patients with advanced or metastatic solid tumors. The study comprises Part A (compound DCBY02) and Part B (compound DCSZ11, not yet active).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: DynamiCure Biotechnology

Criteria

Selected Inclusion Criteria:

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.

Patients with unresectable or metastatic solid tumors, with the exemption of 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 in the first week of Cycle 2.

At least 1 measurable lesion according to RECIST Version 1.1.

Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.

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.

For female patients of childbearing potential must have a negative serum beta-human chorionic gonadotropin (β-hCG) pregnancy test and agree to use highly effective contraception.

For men who are not surgically sterile must agree to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating sperm.

The patient is capable of understanding and complying with the protocol and has signed the required ICF. The appropriate ICF must be signed before relevant study procedures are performed. If applicable, the female partner of a male patient understands and signs the pregnant partner's ICF.

Selected Exclusion Criteria:

Treatment with anticancer therapy, including investigational therapy, within 4 weeks prior to the first dose of study drug.

Patients with > Grade 1 AEs (except Grade 2 alopecia or hearing impairment) related to previous treatment with anticancer or investigational therapy that do not resolve.

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.

Systemic venous thrombotic events (eg, deep vein thrombosis) or pulmonary arterial events (eg, pulmonary embolism) within 1 month prior to the first dose of study drug. Patients with venous thrombotic events prior to the first dose of study drug on stable anticoagulation therapy are eligible.

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.

The patient has marked proteinuria ≥ 2 g/24 hours and/or nephrotic syndrome. Patients with proteinuria 2+ or greater urine dipstick reading should undergo further assessment, eg, 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.

Known allergy or hypersensitivity to any component of the study drug.