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A Study of ZN-c3 in Participants With Solid Tumors

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ClinicalTrials.gov Identifier: NCT04158336
Recruitment Status : Recruiting
First Posted : November 8, 2019
Last Update Posted : November 25, 2019
Sponsor:
Collaborator:
IQVIA Biotech
Information provided by (Responsible Party):
K-Group Beta

Tracking Information
First Submitted Date  ICMJE November 4, 2019
First Posted Date  ICMJE November 8, 2019
Last Update Posted Date November 25, 2019
Estimated Study Start Date  ICMJE November 2019
Estimated Primary Completion Date May 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2019)
  • Safety and tolerability of single agent ZN c3, including identification of the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) [ Time Frame: AEs through Phase 1 completion, an average of 1 year and DLTs through Cycle 1 (each cycle is 21 days) In Phase 1, an average of 1 year ]
    Incidence and severity of adverse events (AEs); Incidence and severity of dose-limiting toxicities (DLTs) in DLT-evaluable participants during Cycle 1
  • Objective response rate (ORR) of ZN c3 as a single agent and in combination with a PARP inhibitor and with a PD-1 inhibitor, respectively [ Time Frame: Through Phase 2 completion, an average of 2 years ]
    ORR as defined by RECIST version 1.1
  • Safety of ZN-c3 in combination with a PARP inhibitor and with a PD-1 inhibitor, respectively, including the determination of a RP2D for the combinations [ Time Frame: Through Phase 2 completion, an average of 2 years ]
    Incidence and severity of DLTs; Incidence and severity of AEs
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04158336 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2019)
Preliminary estimates of antitumor efficacy of single agent ZN-c3 [ Time Frame: Through Phase 1, an average of 1 year ]
Efficacy as defined by RECIST version 1.1
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of ZN-c3 in Participants With Solid Tumors
Official Title  ICMJE A Phase 1/2 Study of ZN-c3 as a Single Agent and in Combination With Talazoparib or Pembrolizumab in Patients With Solid Tumors
Brief Summary This is a Phase 1/2 open-label, multicenter study, evaluating the safety, tolerability, efficacy, pharmacokinetics (PK) and pharmacodynamics of ZN-c3 alone and in combination with other drugs.
Detailed Description This is a Phase 1/2 open-label, multicenter study, evaluating the safety, tolerability, efficacy, pharmacokinetics (PK) and pharmacodynamics of ZN-c3 alone and in combination with other drugs. This study consists of Phase 1 and Phase 2 components in participants with solid tumors.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Solid Tumor
  • Epithelial Ovarian Cancer
  • Fallopian Tube Cancer
  • Peritoneal Cancer
  • Triple Negative Breast Cancer
  • Small Cell Lung Cancer
  • Metastatic Breast Cancer
  • Malignant Melanoma
  • Non Small Cell Lung Cancer
  • Urothelial Carcinoma
Intervention  ICMJE
  • Drug: ZN-c3
    ZN-c3 is a study drug
    Other Name: Study Drug
  • Drug: Talazoparib
    Talazoparib is an approved drug
    Other Name: Talzenna
  • Drug: Pembrolizumab
    Pembrolizumab is an approved drug
    Other Name: Keytruda
Study Arms  ICMJE
  • Experimental: Single Agent Dose Escalation
    Participants with solid tumors with advanced or metastatic disease who are refractory or ineligible to standard therapy(ies) or for whom no standard therapy is available.
    Intervention: Drug: ZN-c3
  • Experimental: Single Agent Phase 2
    Participants with specific types of solid tumors.
    Intervention: Drug: ZN-c3
  • Experimental: Combination with Talazoparib Phase 2
    Participants with a specific type of locally advanced or metastatic breast cancer.
    Interventions:
    • Drug: ZN-c3
    • Drug: Talazoparib
  • Experimental: Combination with Pembrolizumab Phase 2
    Participants with specific types of solid tumors.
    Interventions:
    • Drug: ZN-c3
    • Drug: Pembrolizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 6, 2019)
360
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2023
Estimated Primary Completion Date May 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

In order to be eligible to participate in any phase of this study, an individual must meet all of the following criteria:

  1. Provision of written informed consent.
  2. Age ≥ 18 years or the minimum legal adult age (whichever is greater) at the time of informed consent.
  3. Adequate hematologic and organ function as defined by the following criteria:

    1. Absolute neutrophil count (ANC) ≥ 1.5 × 109/L; excluding measurements obtained within 7 days after daily administration of filgrastim/sargramostim or within 3 weeks after administration of pegfilgrastim.
    2. Platelet count ≥ 100 × 109/L; excluding measurements obtained within 3 days after transfusion of platelets.
    3. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × upper limit of normal (ULN). If liver function abnormalities are due to underlying liver metastases, AST and ALT ≤ 5 x ULN.
    4. Total serum bilirubin ≤ 1.5 × ULN or ≤ 3 × ULN in the case of Gilbert's disease.
    5. Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 60 mL/min.
  4. Female subjects of childbearing potential must have a negative serum beta human chorionic gonadotropin test.
  5. Male subjects and female subjects of childbearing potential must agree to use an effective method of contraception per institutional standard prior to the first dose and for 90 days after the last dose of ZN-c3.

Individuals must meet the additional criteria in order to be eligible to participate in Phase 1:

  1. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
  2. Measurable or evaluable disease per RECIST version 1.1

Individuals must meet these additional criteria in order to be eligible to participate in Phase 2 Single Agent part of the study:

  1. ECOG performance status ≤ 1.
  2. Measurable disease per RECIST version 1.1.

Individuals must meet these additional criteria in order to be eligible to participate in Phase 2 combination with a PARP inhibitor:

  1. ECOG performance status ≤ 1.
  2. Measurable disease per RECIST version 1.1.

Individuals must meet these additional criteria in order to be eligible to participate in Phase 2 combination with a PD-1 inhibitor:

  1. ECOG performance status ≤ 1.
  2. Measurable disease per RECIST version 1.1.

Key Exclusion Criteria:

  1. Any of the following treatment interventions within the specified time frame prior to Cycle 1 Day 1:

    1. Major surgery within 28 days.
    2. Radiation therapy within 21 days.
    3. Any prior systemic therapy regardless of the stop date, but the subject must have recovered to eligibility levels from prior toxicity.
    4. Autologous or allogeneic stem cell transplant within 3 months.
    5. Current use of an investigational agent that is not expected to be cleared by the first dosing of study drug or that has demonstrated to have prolonged side effects. Subjects should have recovered from the side effects to a Grade 0 or 1 (except alopecia).
  2. A serious illness or medical condition(s) including, but not limited to, the following:

    1. Brain metastases that require immediate treatment or are clinically or radiologically unstable.
    2. Leptomeningeal disease that requires or is anticipated to require immediate treatment.
    3. Myocardial impairment of any cause resulting in heart failure by New York Heart Association Criteria Class III or IV.
    4. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the Investigator would make the subject inappropriate for entry into this study.
    5. Significant gastrointestinal abnormalities
    6. Active or uncontrolled infection.
  3. Unresolved toxicity of Grade > 1 attributed to any prior therapies (excluding Grade 2 neuropathy, alopecia or skin pigmentation).
  4. Prior therapy with ZN-c3 or known hypersensitivity to any drugs similar to ZN-c3 in class.
  5. Subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Project Director 8582634333 info@zenopharma.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04158336
Other Study ID Numbers  ICMJE ZN-c3-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party K-Group Beta
Study Sponsor  ICMJE K-Group Beta
Collaborators  ICMJE IQVIA Biotech
Investigators  ICMJE
Study Director: Mieke Ptaszynski, MD K-Group Beta
PRS Account K-Group Beta
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP