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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-20

Study Completion Date

2020-07-24

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Solid Tumor With p53 Wild Type Status

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CGM097 - Dose escalation

Group Type EXPERIMENTAL

CGM097

Intervention Type DRUG

Patients treated with CGM097

CGM097 - Dose Expansion at MTD or RP2D

Group Type EXPERIMENTAL

CGM097

Intervention Type DRUG

Patients treated with CGM097

Interventions

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CGM097

Patients treated with CGM097

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No