Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of ZN-c3 in Participants With Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04158336
Recruitment Status : Not yet recruiting
First Posted : November 8, 2019
Last Update Posted : November 8, 2019
Sponsor:
Collaborator:
IQVIA Biotech
Information provided by (Responsible Party):
K-Group Beta

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.

Condition or disease Intervention/treatment Phase
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 Drug: ZN-c3 Drug: Talazoparib Drug: Pembrolizumab Phase 1 Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Study of ZN-c3 as a Single Agent and in Combination With Talazoparib or Pembrolizumab in Patients With Solid Tumors
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : August 2023


Arm Intervention/treatment
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.
Drug: ZN-c3
ZN-c3 is a study drug
Other Name: Study Drug

Experimental: Single Agent Phase 2
Participants with specific types of solid tumors.
Drug: ZN-c3
ZN-c3 is a study drug
Other Name: Study Drug

Experimental: Combination with Talazoparib Phase 2
Participants with a specific type of locally advanced or metastatic breast cancer.
Drug: ZN-c3
ZN-c3 is a study drug
Other Name: Study Drug

Drug: Talazoparib
Talazoparib is an approved drug
Other Name: Talzenna

Experimental: Combination with Pembrolizumab Phase 2
Participants with specific types of solid tumors.
Drug: ZN-c3
ZN-c3 is a study drug
Other Name: Study Drug

Drug: Pembrolizumab
Pembrolizumab is an approved drug
Other Name: Keytruda




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04158336


Contacts
Layout table for location contacts
Contact: Project Director 8582634333 info@zenopharma.com

Locations
Layout table for location information
United States, Arizona
Site 0102 Not yet recruiting
Tucson, Arizona, United States, 85719
United States, Michigan
Site 0101 Not yet recruiting
Detroit, Michigan, United States, 48201
United States, Texas
Site 0103 Not yet recruiting
Houston, Texas, United States, 77030
Site 0100 Not yet recruiting
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
K-Group Beta
IQVIA Biotech
Investigators
Layout table for investigator information
Study Director: Mieke Ptaszynski, MD K-Group Beta

Layout table for additonal information
Responsible Party: K-Group Beta
ClinicalTrials.gov Identifier: NCT04158336     History of Changes
Other Study ID Numbers: ZN-c3-001
First Posted: November 8, 2019    Key Record Dates
Last Update Posted: November 8, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by K-Group Beta:
Solid tumor
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Lung Neoplasms
Small Cell Lung Carcinoma
Fallopian Tube Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Bronchial Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Ovarian Neoplasms
Endocrine Gland Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms, Glandular and Epithelial
Melanoma
Carcinoma, Ovarian Epithelial
Breast Diseases
Skin Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Nevi and Melanomas
Ovarian Diseases
Adnexal Diseases