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CGM097

Phase 1

Solid Tumor With p53 Wild Type Status | Small molecule | Oncology |Novartis AG|Last Updated: Jun 15, 2021

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment51

FDA Designations

No designations recorded

Clinical trial landscape

CGM097 · 1 trial · 1 indication

Phase 1 1
NCT01760525A Phase I Dose Escalation Study of CGM097 in Adult Patients With Selected Advanced Solid TumorsSolid Tumor With p53 Wild Type Status
COMPLETED51 Analytics
PHASE1COMPLETED
A Phase I Dose Escalation Study of CGM097 in Adult Patients With Selected Advanced Solid Tumors
Solid Tumor With p53 Wild Type Status
NCT0176052551
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Study Endpoints

Primary Endpoints

Incidence of Dose Limiting Toxicities
From day 1 to day 28 of treatment

To characterize the maximum tolerated dose (MTD) and/or identify the recommended dose for expansion(RDE) of CGM097. Dose Limiting Toxicities will be listed and their incidence summarized by primary system organ class, worst grade based on CTCAE version 4.03 and type of Adverse Event

Secondary Endpoints

Pharmacokinetic profile of CGM097
At Cycle 1 Day 1, 2, 5, 8, 15 and 22, then each first day of the Cycle (28 days per Cycle) until discontinuation.
Tumor response per RECIST
Baseline, then every third cycle (approximately every 12 weeks), until disease progression or discontinuation.
Pharmacodynamic effect of CGM097
At baseline, Cycle 2 Day 8 and at disease progression.
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CGM097 - Dose escalationEXPERIMENTAL -
CGM097 - Dose Expansion at MTD or RP2DEXPERIMENTAL -

Interventions

NameTypeDescription
CGM097DRUGPatients treated with CGM097
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

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 trea...

Countries:United StatesFranceGermanySingaporeSwitzerland
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Frequently asked questions about CGM097

What is CGM097 used for?

CGM097 is an investigational small molecule being studied for the treatment of solid tumors with p53 wild type status. It is being developed by Novartis AG for use in oncology. As of the available data, it is in Phase 1 clinical development and has not been approved by regulatory authorities.

What does CGM097 target?

CGM097 is a small molecule designed to treat solid tumors with p53 wild type status. The specific molecular target of CGM097 is not disclosed in the available information. It is being investigated for its potential role in oncology, specifically in patients whose tumors have the wild type p53 gene.

Who makes CGM097?

CGM097 is being developed by Novartis AG, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol NVS. The drug is an investigational small molecule in Phase 1 clinical development for the treatment of solid tumors with p53 wild type status.

What phase is CGM097 in?

CGM097 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory authority. The drug is being studied for the treatment of solid tumors with p53 wild type status, and its clinical development is ongoing.

What clinical trials is CGM097 in?

CGM097 has been studied in one clinical trial, identified by the National Clinical Trial number NCT01760525. This was a Phase 1 dose escalation study in adult patients with selected advanced solid tumors. The trial enrolled 51 participants and has been completed. The study was conducted in the United States, France, Germany, Singapore, and Switzerland.

Is CGM097 the same as any other drug?

CGM097 is not known to have any alternative names. It is a distinct investigational small molecule being developed by Novartis AG for the treatment of solid tumors with p53 wild type status. No other names for this drug have been identified in the available information.