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NCT06589830

TL938 and Trastuzumab for Patients With HER2-positive Metastatic Colorectal Cancer

StatusRecruiting
PhasePhase 2
Primary completion (estimated)

At risk: Primary completion moved at least 2 years 1 month later.

See at-risk trials from Teligene US

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Record History

All 6 versions: 6 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Oct 2026 to Dec 2028 Show 7 more changesShow less
    • Sponsor changed: Suzhou Teligene Ltd. to Teligene US
    • Eligibility criteria shortened, about 160 words
    • Enrollment increased: 80 → 110 participants
    • Study completion pushed from Oct 2027 to Dec 2029
    • Trial arms changed: 2 → 3
    • Secondary endpoints: details revised at 3 of 21 entries
    • Collaborators expanded, about 3 words
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jul 2025 to May 13, 2025
    v5
  3. Start date: Dec 2024 to Jul 2025v4
  4. Start date: Oct 2024 to Dec 2024v3
  5. Secondary endpoints: details revised at 1 of 21 entries
    • Primary endpoints revised (2)
    • Study arms: 3 to 2
    v2
  6. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Dose limiting toxicity, maximum tolerated dose, and recommended phase 2 dose
Timeframe: Pre-dose up to approximately 24 months post-dose
Objective Response Rate (ORR) by IRC
Timeframe: Pre-dose up to approximately 24 months post-dose

Secondary (21)

Objective Response Rate (ORR) by Investigator
Duration of Response (DoR)
Disease Control Rate (DCR)
Progression Free Survival (PFS)
Time to Tumor Progression (TTP)
Show 16 moreShow less
Time to Treatment Failure (TTF)
Time to Response (TTR)
Overall Survival (OS)
1-year Progression Free Survival
1-year Survival
Number of Participants Experiencing Adverse Events (AE)
Number of Participants Experiencing Adverse Drug Reactions (ADR)
Number of Participants Experiencing Serious Adverse Events (SAE)
Number of Participants Experiencing Serious Adverse Reactions (SAR)
Area Under The Curve (AUC) of TL938
Maximum Plasma Concentration (Cmax) of TL938
Minimum Plasma Concentration (Cmin) of TL938
Time to Peak Drug Concentration (Tmax) of TL938
TL938 half-life (T1/2)
Volume of Distribution (Vz/F) of TL938
Apparent Clearance (CL/f) of TL938

Arms and interventions

Cohort 2: TL938 + TrastuzumabExperimental

TL938 orally once daily at the recommended Phase 2 dose, plus trastuzumab intravenously on Day 1 of each 21-day cycle.

Cohort 3: TL938 MonotherapyExperimental

TL938 orally once daily at the recommended Phase 2 dose, in 21-day cycles.

Cohort 1: TL938 + Trastuzumab Dose Escalation/OptimizationExperimental

TL938 orally once daily at assigned dose levels, plus trastuzumab intravenously on Day 1 of each 21-day cycle, to determine the recommended Phase 2 dose.

Drugs: TL938 Capsules, Trastuzumab

Sites

1 site in 1 country

  • Cancer Hospital, Chinese Academy of Medical SciencesBeijing, Beijing Municipality, China