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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
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment51
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01760525A Phase I Dose Escalation Study of CGM097 in Adult Patients With Selected Advanced Solid TumorsPHASE1 COMPLETED 51 — — Mar 20, 2013Jul 24, 2020Jun 15, 20215 United States, France +3
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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 — 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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