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

Completed · Phase 1

Conditions studied: Solid Tumor With p53 Wild Type Status

In brief

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).

Key facts

Study ID

NCT01760525

Run by

Novartis Pharmaceuticals

People needed

51

Starts

2013-03-20

Expected to finish

2020-07-24

Last updated by the study team

2021-06-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Dana Farber Cancer Institute SC (2) — Boston, Massachusetts, United States
• Novartis Investigative Site — Lyon, France
• Novartis Investigative Site — Essen, Germany
• Novartis Investigative Site — Singapore, Singapore
• Novartis Investigative Site — Zurich, Switzerland

Full record on ClinicalTrials.gov

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