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A Study of ZN-c3 in Combination With Gemcitabine in Subjects With Osteosarcoma

Primary Purpose

Osteosarcoma

Status

Recruiting

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

ZN-c3

Gemcitabine

About this trial

This is an interventional treatment trial for Osteosarcoma

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥ 12 years at the time of informed consent
Bodyweight ≥ 40 kg
Histologically documented relapsed or metastatic osteosarcoma.
Must have measurable disease according to RECIST Guideline version 1.1 criteria.
Adequate hematologic and organ function.
Female subjects of childbearing potential and male subjects must agree to use an effective method of contraception per institutional standard prior to the first dose and for 6 months after study treatment discontinuation.
Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

Unresolved toxicity of Grade >1 attributed to prior therapies (excluding: Grade ≤2 neuropathy, alopecia, or skin pigmentation)
Prior therapy with a WEE1 inhibitor
A serious illness or medical condition(s).
Pregnant or lactating females. Females of childbearing potential with a positive serum pregnancy test <14 days to Day 1.
Subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy.
12-lead ECG demonstrating a corrected QT interval using Fridericia's formula (QTcF) of >470 ms, except for subjects with atrioventricular pacemakers or other conditions (e.g., right bundle branch block) that render the QT measurement invalid.
History or current evidence of congenital or family history of long QT syndrome or Torsades de Pointes (TdP).
Taking medications with a known risk of TdP.
Administration of strong and moderate CYP3A4 inhibitors/inducers and strong and moderate P-gp inhibitors.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Combination ZN-c3 with Gemcitabine

Arm Description

Outcomes

Primary Outcome Measures

Incidence of dose-limiting toxicities (DLT) in DLT evaluable subjects and the incidence and severity of adverse events.

Event-free survival (EFS) at 18 weeks per RECIST (Response Evaluation Criteria in Solid Tumors) Guideline version 1.1.

EFS at 18 weeks is defined as time from study enrollment until date of disease progression, or detection of disease at a previously uninvolved site, or date of death of the subjects at 18 weeks.

Secondary Outcome Measures

Event-free survival (EFS) per RECIST Guideline version 1.1.

EFS is defined as time from study enrollment until date of last contact, date of disease progression, or detection of disease at a previously uninvolved site, or date of death.

Median overall survival (OS) and OS at 12 months per RECIST Guideline version 1.1.

OS is defined as the time from date of first dosing until the date of death.

The frequency and severity of adverse events (AEs) and laboratory abnormalities per the National Cancer Institute Common Terminology (NCI CTCAE) version 5.0.lities.

Plasma pharmacokinetics (PK) maximum concentration (Cmax).

Plasma PK time to maximum concentration (Tmax).

Area under the plasma concentration versus timepoint curve (AUC last).

Terminal half-life of the plasma PK concentration.

Full Information

NCT ID

NCT04833582

First Posted

March 25, 2021

Last Updated

January 30, 2023

Sponsor

K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc

1. Study Identification

Unique Protocol Identification Number

NCT04833582

Brief Title

A Study of ZN-c3 in Combination With Gemcitabine in Subjects With Osteosarcoma

Official Title

A Phase 1/2 Dose Escalation and Dose Expansion Study of ZN-c3 in Combination With Gemcitabine in Adult and Pediatric Subjects With Relapsed or Refractory Osteosarcoma

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 1, 2021 (Actual)

Primary Completion Date

August 30, 2023 (Anticipated)

Study Completion Date

December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a phase 1/2 study of ZN-c3 in combination with gemcitabine in adult and pediatric subjects with relapsed or refractory osteosarcoma.

Detailed Description

This is a phase 1/2 dose escalation and dose expansion study, evaluating the clinical activity and safety, pharmacodynamics, and pharmacokinetics of ZN-c3 in combination with gemcitabine in relapsed or refractory osteosarcoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteosarcoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Combination ZN-c3 with Gemcitabine

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

ZN-c3

Intervention Description

ZN-c3 is an investigational drug.

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Other Intervention Name(s)

Gemzar

Intervention Description

Gemcitabine is an approved drug

Primary Outcome Measure Information:

Title

Incidence of dose-limiting toxicities (DLT) in DLT evaluable subjects and the incidence and severity of adverse events.

Time Frame

Through Cycle 1 (21 days) Phase 1

Title

Event-free survival (EFS) at 18 weeks per RECIST (Response Evaluation Criteria in Solid Tumors) Guideline version 1.1.

Description

EFS at 18 weeks is defined as time from study enrollment until date of disease progression, or detection of disease at a previously uninvolved site, or date of death of the subjects at 18 weeks.

Time Frame

During phase 2, at 18 weeks

Secondary Outcome Measure Information:

Title

Event-free survival (EFS) per RECIST Guideline version 1.1.

Description

EFS is defined as time from study enrollment until date of last contact, date of disease progression, or detection of disease at a previously uninvolved site, or date of death.

Time Frame

At 12 months

Title

Median overall survival (OS) and OS at 12 months per RECIST Guideline version 1.1.

Description

OS is defined as the time from date of first dosing until the date of death.

Time Frame

At 12 months

Title

The frequency and severity of adverse events (AEs) and laboratory abnormalities per the National Cancer Institute Common Terminology (NCI CTCAE) version 5.0.lities.

Time Frame