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Telaglenestat

Phase 1/2

Solid Tumors | Small Molecules | Oncology |Calithera Biosciences, Inc|Trials Updated: Sep 19, 2022

Telaglenestat target and mechanism

Target class-Stat (Enzyme)
ModalitySmall Molecules

Also known as Telaglenestat (CB-839)

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment53

FDA Designations

No designations recorded

Telaglenestat clinical trials

Telaglenestat · 1 trial · 4 indications

Phase 1/2 1
NCT03965845A Study of Telaglenastat (CB-839) in Combination With Palbociclib in Patients With Solid TumorsSolid Tumors
COMPLETED53 Analytics
PHASE1/PHASE2COMPLETED
A Study of Telaglenastat (CB-839) in Combination With Palbociclib in Patients With Solid Tumors
Solid Tumors
NCT0396584553
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Study Endpoints

Primary Endpoints

Safety and Tolerability of telaglenestat (CB-839) in combination with palbociclib: (CR) number of participants with treatment related adverse events
Start of treatment to 28 days post treatment

Number of participants with treatment related adverse events as assessed by CTCAE v5.0

Maximum tolerated dose and/or Recommended Phase 2 Dose:
Measured from Part 1 patients only within their first 28 day cycle

Incidence and nature of dose-limiting toxicities

Secondary Endpoints

Maximum plasma concentration of telaglenastat and palbociclib:
PKs are drawn on two different days (Day 8 and Day 15) during Cycle 1
Anti-tumor activity of telaglenestat and palbociclib:
Approximately every 8 weeks until disease progression, for approximately 18 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1: Telaglenastat 600 mg and Palbociclib 75 mgEXPERIMENTAL -
Cohort 2: Telaglenastat 800 mg and Palbociclib 75 mgEXPERIMENTAL -
Cohort 3: Telaglenastat 800 mg and Palbociclib 100 mgEXPERIMENTAL -
Cohort 3: Telaglenastat 800 mg and Palbociclib 125 mgEXPERIMENTAL -
Part 2: ExpansionEXPERIMENTALThe recommended phase 2 dose (RP2D) determined from Part 1 will be the treatment for all cohorts in expansion Part 2.

Interventions

NameTypeDescription
Telaglenestat (CB-839)DRUGTeleglenastat is an oral tablet administered twice daily with food at the assigned dose level. Dose is taken with palbociclib each day in 28-day cycles.
Palbociclib Oral Capsule or Tablet [Ibrance]DRUGPalbociclib (Ibrance) is an oral capsule or tablet administered once daily with food on Days 1-21 of every 28-day cycle in combination with telaglenestat. Days 22-28 of every cycle, palbociclib is not taken.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites10

Inclusion Criteria: * Part 1: Have documented incurable/locally advanced or metastatic solid tumors that have either relapsed or are refractory or intolerant to the standard therapies of proven clinical benefit. * Part 2: Availability of archival tumor tissue block or slides (Fresh tumor biopsy wil...

Countries:United States
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Competitive Landscape -Other Solid Tumors 10 trials (matched to "Solid Tumors")

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK3PHASE2Pembrolizumab, Gardasil 9
Incyte CorporationINCY1PHASE2Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115
Iovance Biotherapeutics IncIOVA2PHASE2Aldesleukin
AstraZeneca PLCAZN1 - Trastuzumab deruxtecan
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