Z0011001 - A Phase 1/2, Open-Label, Multi-Center Study of ZN-c3 Administered in Combination With Encorafenib and Cetuximab in Adults With Metastatic Colorectal Cancer.

Studio Clinico

Patologia: Tumori del colon retto

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: 1, II

Linee di trattamento: Seconda linea, Terza/N linea

Criteri di inclusione: 

- Histologically or cytologically confirmed metastatic Stage IV colorectal adenocarcinoma.
- Documented evidence of a BRAF V600E mutation in tumor tissue or blood.
- Presence of measurable disease per RECIST version 1.1 guidelines.
- Disease progression after 1 or 2 previous systemic regimens for metastatic disease.
- Adequate bone marrow function.
- Adequate hepatic and renal function.

Criteri di esclusione: 

- Documented clinical disease progression or radiographic disease progression during the screening period.
- Leptomeningeal disease.
- Symptomatic brain metastasis.
- Presence of acute or chronic pancreatitis.
- Unable to swallow, retain, and absorb oral medications.
- Clinically significant cardiovascular diseases
- Evidence of active noninfectious pneumonitis.
- Evidence of active and uncontrolled bacterial or viral infection, within 2 weeks prior to start of any of the study interventions.
- Participants with known positivity for HIV.
- Active hepatitis B or hepatitis C infection.
- Concurrent or previous other malignancy within 2 years of study entry.
- Has had an allogeneic tissue/solid organ transplant.
- Pregnant or females of childbearing potential who have a positive β-hCG laboratory test result within 14 days prior to enrollment or is breastfeeding.

Numero di pazienti previsti: 

10

Schema di trattamento: 

Experimental: Dose Escalation
Participants will receive different doses of ZN-c3 in combination with different doses of Encorafenib and a fixed dose of Cetuximab
Experimental: Dose Expansion
Participants will receive recommended dose of ZN-c3 and encorafenib as determined in dose escalation phase in combination with cetuximab.

Trattamento sperimentale: 

ZN-c3 + Encorafenib + Cetuximab

Trattamento di controllo: 

NA

Obiettivi primari dello studio: 

Dose Escalation Phase - Incidence of Dose Limiting Toxicities (DLTs) [Time Frame: From Lead-in Day -1 to Cycle 1 Day 28]
DLTs defined as treatment-related AEs occurring within the first 29 days after the start of any study treatment that in the opinion of the investigator cannot be reasonably attributed to the participant's underlying disease, concomitant medications, or pre-existing conditions.
Dose Expansion Phase - Objective response rate (ORR) [Time Frame: From first dose of any study intervention every 8 weeks during treatment, up to 12 months]
ORR defined as the proportion of participants who achieves a best overall response of Complete Response (CR) or Partial Response (PR), assessed by Investigator per RECIST Version 1.1.

Data di inizio dell'arruolamento: 27.02.2023

Data di fine dell'arruolamento: 02.07.2026

Centri partecipanti

Nord Italia

Sud Italia e isole

Informazioni Generali

Protocollo

Numero di iscrizione a registro: NCT05743036

Data di inserimento: 09.10.2023

Promotore

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

CRO

SYNEOS HEALTH

Principal Investigator ITALIA

Riferimento: Dr. Info non applicabile (nuovo Regolamento Europeo)

Telefono: 00000

Email: na@na.it

Localita: na