A Phase 1, Multicenter, Open-Label, Dose Escalation, and Dose Expansion Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of DCBY02 (Part A) or DCSZ11 (Part B) as a Monotherapy in Patients With Advanced or Metastatic Solid Tumors

  • STATUS
    Recruiting
  • End date
    Oct 11, 2024
  • participants needed
    96
  • sponsor
    DynamiCure Biotechnology
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Updated on 11 October 2022
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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).

Details
Condition Advanced or Metastatic Solid Tumors
Treatment DCBY02
Clinical Study IdentifierNCT05496595
SponsorDynamiCure Biotechnology
Last Modified on11 October 2022

Eligibility

 Yes No Not Sure

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

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
-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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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