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NCT07109726

A Phase 1/2 Trial of TER-2013 in Patients With Solid Tumors Harboring AKT/PI3K/PTEN Pathway Alterations

StatusRecruiting
PhasePhase 1/2
Primary completion (estimated)

At risk: Primary endpoint(s) modified.

See at-risk trials from Terremoto Biosciences Inc.

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Record History

All 14 versions: 14 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary endpoint(s) modified Show 5 more changesShow less
    • Enrollment increased: 205 → 248 participants
    • Trial sites expanded: 20 → 25 locations
    • Interventions modified
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: 6 to 7
  2. Study sites: 18 to 20
    • Eligibility criteria expanded, about 21 words
    • Secondary endpoints: details revised at 3 of 6 entries
  3. Trial sites expanded: 15 → 18 locationsv12
  4. Site details revised at 1 of 15 sitesv11
  5. Study sites: 14 to 15v10
Show 8 earlier versionsHide 8 earlier versions
  1. Study sites: 12 to 14v9
  2. Study sites: 10 to 12v8
  3. Study sites: 8 to 10v7
  4. Study sites: 6 to 8v6
  5. Study sites: 4 to 6v5
  6. Study sites: 3 to 4
    • Start date changed from estimate of Aug 2025 to Sep 23, 2025
    v4
  7. Study sites: 1 to 3v3
  8. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Number of Patients who Experience Dose-Limiting Toxicity
Timeframe: 28 Days
Number of patients who experience a treatment-related adverse event
Timeframe: Up to 2 years
Objective Response Rate as assessed by RECIST v1.1
Timeframe: Up to 2 years
Duration of Response as assessed by RECIST v1.1
Timeframe: Up to 2 years
Progression-Free survival as assessed by RECIST v1.1
Timeframe: Up to 2 years
Over-all survival as assessed by RECIST v1.1
Timeframe: Up to 2 years

Secondary (7)

Area under the plasma concentration-time curve for a dosing interval (AUCτ) of TER-2013
Maximum concentration (Cmax) of TER-2013
Time to maximum concentration (Tmax) of TER-2013
Terminal elimination half-life (T1/2) of TER-2013
Changes of pharmacodynamic markers of TER-2013 in tissue and/or blood as assessed by pAKT
Show 2 moreShow less
Changes of pharmacodynamic markers of TER-2013 in tissue and/or blood as assessed by pPRAS40
TER-2013 plasma PK parameters following single-dose administration under fed and fasted conditions

Arms and interventions

Monotherapy Dose EscalationExperimental
Combination Therapy Dose EscalationExperimental

Dose Escalation of TER-2013 with recommended dose of fulvestrant

Monotherapy Dose ExpansionExperimental
Combination Therapy Dose ExpansionExperimental

Dose Expansion of TER-2013 with recommended dose of fulvestrant

Drugs: TER-2013, Fulvestrant injection

Sites

25 sites in 5 countries

United States 17, Spain 4, Portugal 2, Ireland 1, Puerto Rico 1