A Phase I Dose Escalation Study of CGM097 in Adult Patients With Selected Advanced Solid Tumors (CCGM097X2101)

Novartis

Status and phase

Completed

Phase 1

Conditions

Solid Tumor With p53 Wild Type Status

Treatments

Drug: CGM097

Study type

Interventional

Funder types

Industry

Identifiers

NCT01760525

CCGM097X2101

2012-000940-87 (EudraCT Number)

Details and patient eligibility

About

This is a first in human phase I study of single agent CGM097 in patients with advanced solid tumors who have progressed despite standard therapy or for whom no standard therapy exists. The tumor must be characterized by p53wt status. The study consists of a dose escalation part where patients will receive escalating doses of CGM097, and a dose expansion part in which patients are given CGM097 at the maximum tolerated dose (MTD) or Recommended Phase 2 Dose (RP2D). Each dose escalation step will be decided based on the recommendation from an adaptive Bayesian logistic regression model (BLRM).

Full description

This is a multi-center, open-label, dose finding, phase I study of single agent CGM097, administered in patients with advanced solid tumors who have progressed despite standard therapy or for whom no standard therapy exists. Patients' tumors must be characterized by p53wt status.

The study consists of a dose escalation part, where cohorts of three to six newly enrolled patients will receive escalating doses of CGM097, and a dose expansion part, in which patients are given CGM097 the maximum tolerated dose (MTD) or Recommended Phase 2 Dose (RP2D). Novartis and the site investigators will jointly decide on each dose escalation step based on the recommendation from an adaptive Bayesian logistic regression model (BLRM). If safety data should indicate a lower increment than suggested by the BLRM, the next dose level (DL) will be adjusted accordingly.

Enrollment

51 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient has advanced solid malignancy that has progressed despite standard therapy, or for which no effective standard therapy exists
Tumor of the patient is p53wt
Evaluable disease as determined by RECIST 1.1
WHO performance status 0-2

Exclusion criteria

Prior treatment with CGM097 or other p53/HDM2-interaction inhibitor
Patient with symptomatic or growing CNS metastatic lesions
Concurrent other malignancy
Clinically significant cardiac disease as defined in the protocol
Diagnosis of acute or chronic pancreatitis
Concomitant therapy that precludes enrollment, as defined in the protocol
Women of child-bearing potential, unless they are using highly effective methods of contraception during dosing and for 2 weeks after study drug discontinuation
Pregnant or nursing women

Other protocol-defined inclusion/exclusion criteria may apply.