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Protocol # 20-671

Status

Recruiting

Description

This is a phase Ib/II open label study. The escalation part will characterize the safety and tolerability of JDQ443 single agent and JDQ443 in combination with the other study treatments (TNO155 and tislelizumab) in advanced solid tumor patients. After the determination of the maximum tolerated dose / recommended dose for a particular treatment arm, dose expansion will assess the anti-tumor activity and further assess the safety, tolerability, and PK/PD of each regimen at the maximum tolerated dose / recommended dose or lower dose.

Condition

  • KRAS G12C Mutant Solid Tumors
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Colorectal
  • Cancer of Lung
  • Cancer of the Lung
  • Lung Cancer
  • Neoplasms, Lung
  • Neoplasms, Pulmonary
  • Pulmonary Cancer
  • Pulmonary Neoplasms

Interventions

  • JDQ443
  • TNO155
  • tislelizumab

Phase

Phase 1/Phase 2

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Dose Escalation: Incidence and severity of dose limiting toxicities (DLTs) during the first cycle of monotherapy or combination treatment
  • Dose Escalation: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
  • Dose Escalation: Frequency of dose interruptions and reductions, by treatment
  • Dose Escalation: Dose intensity by treatment
  • Dose Expansion: Overall response rate (ORR) per RECIST v1.1, by treatment
  • Dose expansion: Overall intracranial response rate (OIRR) per mRANO-BM
  • Dose expansion: Incidence and severity of AEs and SAEs
  • Dose expansion: frequency of dose interruptions and reductions, by treatment
  • Dose expansion: Dose intensity by treatment
  • Dose expansion: ORR per RECIST 1.1 of JDQ443 single agent in patients with non-small cell lung cancer (JDQ443 dose randomization group only)

Secondary Outcome:

  • Dose Escalation and Expansion: ORR per RECIST v1.1
  • Dose Escalation and Expansion: Best Overall Response (BOR) per RECIST v1.1
  • Dose Escalation and Expansion: Progression-free survival (PFS) per RECIST v1.1, Overall Survival (OS)
  • Dose Escalation and Expansion: Duration of Response (DOR) per RECIST v1.1
  • Dose Escalation and Expansion: Disease Control Rate (DCR) per RECIST v1.1
  • Dose Escalation and Expansion: Plasma or serum concentration vs time profiles (AUC) by treatment
  • Dose Escalation and Expansion: Plasma concentration (Cmax) by treatment
  • Dose Escalation and Expansion: Time to achieve Cmax (Tmax) by treatment
  • Dose Escalation and Expansion: Antidrug antibody (ADA) incidence by treatment
  • Dose Expansion: Dose intensity by treatment
  • Dose Expansion: Frequency of dose interruptions and reductions, by treatment
  • Dose Expansion: Incidence and severity of dose limiting toxicities (DLTs) during the first cycle of monotherapy or combination treatment
  • Dose Expansion: Incidence and severity of AEs and SAEs by treatment
  • Dose expansion: Intracranial disease control rate (IDCR) per mRANO-BM
  • Dose expansion: Best overall intracranial response (BOIR) per mRANO-BM
  • Dose expansion: Intracranial progression free survival (IPFS) per mRANO-BM
  • Dose expansion: Duration of intracranial response (DOIR) per mRANO-BM

Enrollment

475

Study Start Date

February 24, 2021

Eligibility

  • Gender:     All
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

Novartis Pharmaceuticals

Source

Novartis

Official title

A Phase Ib/II Open-label, Multi-center Dose Escalation Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation

Clinicaltrials.gov Identifier

NCT04699188

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.