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Phase I Study of ZN-c3 and Bevacizumab ± Pembrolizumab in Metastatic CCNE1 Amplified and TP53 Mutant Solid Tumors | Clinical Trials | Clareo Health

WITHDRAWNPHASE1

Phase I Study of ZN-c3 and Bevacizumab ± Pembrolizumab in Metastatic CCNE1 Amplified and TP53 Mutant Solid Tumors

NCT05431582•M.D. Anderson Cancer Center

View on ClinicalTrials.gov

Summary

Primary Objectives are to determine the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of ZN-c3 and ZN-c3 and bevacizumab or ZN-c3 and bevacizumab plus pembrolizumab in metastatic CCNE1 amplified and TP53 mutant solid tumors as well to evaluate antitumor activity of ZN-c3 and bevacizumab or ZN-c3 and bevacizumab plus pembrolizumab in metastatic CCNE1 amplified and TP53 mutant solid tumors.

Detailed Description

Primary Objectives: * To determine the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of ZN-c3 and ZN-c3 and bevacizumab or ZN-c3 and bevacizumab plus pembrolizumab in metastatic CCNE1 amplified and TP53 mutant solid tumors. * To evaluate antitumor activity of ZN-c3 and bevacizumab or ZN-c3 and bevacizumab plus pembrolizumab in metastatic CCNE1 amplified and TP53 mutant solid tumors. Secondary Objectives: * To assess progression-free survival (PFS), overall survival (OS), and duration of response (DOR) * To explore potential biomarkers. * To explore patient reported outcomes (PRO).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients must have histologically confirmed metastatic solid tumors harboring CCNE1 amplification and TP53 mutation pre-identified in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory, either refractory to standard therapy or for which no effective standard therapy that increases survival for at least 3 months is available, or they declined standard of care therapy.
•2. Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
•3. Male or female aged ≥18 years.
•4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
•Adequate organ functions as defined below:
•Absolute neutrophil count (ANC) ≥ 1,500 /μL. Hemoglobin (Hb) ≥ 8 g/dL. Platelets ≥ 100,000 /μL. Total bilirubin ≤ 1.5 x upper limit of normal (ULN); or total bilirubin \< 3.0 x ULN with direct bilirubin ≤ ULN in patients with well documented Gilbert's Syndrome.
•ALT ≤ 3 ULN or ≤ 5 ULN if liver metastases persist. Serum albumin ≥ 3 g/dL. Urinalysis ≤ 1 proteinuria, or urine protein/creatinine ratio (UPCR) ≤ 1 mg/mg (≤ 113.2 mg/mmol), or 24-h urine protein ≤ 1 g.
•PT/INR or partial thromboplastin time (PTT) test \< 1.3 the laboratory ULN if not on therapeutic anticoagulation.
•Calculated creatinine clearance (CrCl) ≥ 60 mL/min by the Cockcroft-Gault method\* or 24-hour urine collection.
•\* CrCl = (140-age) x (weight/kg) x Fa / (72 x serum creatinine mg/dL). a where F= 0.85 for females and F=1 for male
+16 more criteria

Exclusion Criteria

•1. Any treatment specifically for systemic tumor control given within 3 weeks before the initiation of therapy; within 2 weeks if cytotoxic agents were given weekly, within 6 weeks for nitrosoureas or mitomycin C; within 5 half-lives for targeted agents with half-lives and pharmacodynamic effects lasting \< 5 days; or failure to recover from toxic effects of any previous therapy. A drug that has not received regulatory approval for any indication within 14 or 21 days of treatment for a non-myelosuppressive or myelosuppressive agent, respectively: patients must recover for previous cancer therapy, and are ready to proceed with further cancer therapy.
•2. Uncontrolled intercurrent illness including but not limited to:
•* ongoing or active infection requiring intravenous antibiotics
•* symptomatic congestive heart failure (New York Heart Association Class III or IV)
•* history of myocardial infarction, unstable angina, stroke or transient ischemic attack within 6 months before study enrollment
•* lesions invading or encasing any major blood vessels and cavitating pulmonary lesion(s) or known endotracheal or endobronchial disease manifestation
•* Uncontrolled hypertension defined as sustained blood pressure (BP) \> 140 mm Hg systolic or \> 90 mm Hg diastolic despite optimal antihypertensive treatment
•* history or current evidence of uncontrolled ventricular arrhythmia
•* congenital long QT syndrome, or any known history of torsade de pointes, or family history of unexplained sudden death
•* clinically significant bleeding or active gastric or duodenal ulcer
+14 more criteria

Key Dates

Start Date

December 14, 2022

Primary Completion Date

December 14, 2022

Completion Date

December 14, 2022

Last Updated

June 15, 2023

Conditions

TumorsOvarian CancerBreast CancerLung CancerPancreatic Cancer

Interventions

ZN-c3

DRUG

Bevacizumab

DRUG

Pembrolizumab

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 15, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Phase I Study of ZN-c3 and Bevacizumab ± Pembrolizumab in Metastatic CCNE1 Amplified and TP53 Mutant Solid Tumors

Inclusion Criteria

Exclusion Criteria

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