A Phase 1b Study of ZN-c3 in Chinese Subjects

NCT04972422 | Unknown Phase 1

• 1 other identifier: c3ZTCN100
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 3

Brief Summary

This is a Phase 1b open-label, multicenter study, evaluating the safety, tolerability, efficacy, pharmacokinetics (PK) and pharmacodynamics of ZN c3.

Conditions

Solid Tumors

Keywords

Solid Tumors

Outcome Measures

Primary Outcomes (2)

• Incidence and severity of adverse events (AEs)

  Graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0

  Until 30 days after the last dose of study drug

• Incidence and severity of dose-limiting toxicities (DLTs) in DLT evaluable subjects during Cycle 1

  At the end of Cycle 1 (each cycle is 21 days)

Study Arms (1)

Single Agent Dose Escalation

EXPERIMENTAL

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

Interventions

ZN-c3 DRUG

ZN-c3 is a study drug

Also known as: Study Drug

Single Agent Dose Escalation

Eligibility Criteria

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

You may qualify if:

• Provision of written informed consent prior to initiation of any study-related procedures that are not considered standard of care.
• Age ≥ 18 years or the minimum legal adult age (whichever is greater) at the time of informed consent.
• Adequate hematologic and organ function as defined by the following criteria:
• 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.
• Platelet count ≥ 100 × 109/L; excluding measurements obtained within 3 days after transfusion of platelets.
• 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.
• Total serum bilirubin ≤ 1.5 × ULN or ≤ 3 × ULN in the case of Gilbert's disease.
• Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 60 mL/min.
• Female subjects of childbearing potential must have a negative serum beta human chorionic gonadotropin test.
• 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.
• Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
• Willingness to practice adequate sun protection (use of sunscreen or sun-protective clothing or limitation of sun exposure).
• Eastern Cooperative Oncology Group (ECOG) performance status ≤1
• Subjects must have a solid tumor with advanced or metastatic disease, refractory to standard therapy or for whom no standard therapy is available, or the subject is ineligible for standard therapy(ies).
• Measurable or evaluable disease per RECIST version 1.1.

You may not qualify if:

• Any of the following treatment interventions within the specified time frame prior to Cycle 1 Day 1:
• Major surgery within 28 days (the surgical incision should be fully healed prior to study drug administration).
• Radiation therapy within 21 days; however, if the radiation portal covered ≤ 5% of the bone marrow reserve, the subject is eligible irrespective of the end date of radiotherapy.
• Any prior systemic therapy regardless of the stop date, but the subject must have recovered to eligibility levels from prior toxicity.
• Autologous or allogeneic stem cell transplant within 3 months.
• 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).
• A serious illness or medical condition(s) including, but not limited to, the following:
• Brain metastases that require immediate treatment or are clinically or radiologically unstable (i.e., have been stable for \< 1 month). If receiving steroids, subjects must be receiving a stable to decreasing corticosteroid dose during at least 1 week before enrollment.
• Leptomeningeal disease that requires or is anticipated to require immediate treatment.
• Myocardial impairment of any cause (e.g. cardiomyopathy, ischemic heart disease, significant valvular dysfunction, hypertensive heart disease, and congestive heart failure) resulting in heart failure by New York Heart Association Criteria (Class III or IV).
• 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.
• Significant gastrointestinal abnormalities, including an inability to take oral medication, requirement for IV alimentation, active peptic ulcer, chronic diarrhea or vomiting considered to be clinically significant in the judgment of the Investigator, or prior surgical procedures affecting absorption.
• Active or uncontrolled infection. Subjects with an infection receiving treatment (antibiotic, antifungal or antiviral treatment) may be entered into the study but must be afebrile and hemodynamically stable for ≥ 72 hours.
• Unresolved toxicity of Grade \> 1 attributed to any prior therapies (excluding Grade 2 neuropathy, alopecia or skin pigmentation).
• Prior therapy with ZN-c3 or known hypersensitivity to any drugs similar to ZN c3 in class.

Sponsors & Collaborators

• Zentera Therapeutics HK Limited: lead

Study Sites (3)

Fudan University Zhongshan Hospital

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Sichuan University Huaxi Hospital

Chengdu, Sichuan, China

RECRUITING

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Interventions

Drug Evaluation

Intervention Hierarchy (Ancestors)

Drug Development; Investigative Techniques; Evaluation Studies as Topic

Central Study Contacts

Xu Li, M.Sc

CONTACT

+86 15902153353; xli@zenteratx.com

Study Design

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

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: July 22, 2021
• Study Start: July 15, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2023
• Last Updated: September 5, 2021

Record last verified: 2021-07

Locations

CN (3)