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FiREBOLTNCT07213791

A Study of LY4337713 in Participants With FAP-Positive Solid Tumors

StatusRecruiting
PhasePhase 1
Primary completion (estimated)
Track this trial

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Record History

All 22 versions: 22 with changes below. See every version on ClinicalTrials.gov ↗

  1. Site details revised at 1 of 30 sites
  2. Enrollment increased: 241 → 340 participants
    • Eligibility criteria expanded, about 57 words
    • Secondary endpoints revised (8)
  3. Eligibility criteria expanded, about 31 words
    • Study sites revised (30)
  4. Site details revised at 1 of 30 sitesv19
  5. Site details revised at 3 of 30 sitesv18
Show 16 earlier versionsHide 16 earlier versions
  1. Site details revised at 2 of 30 sitesv17
  2. Study sites: 29 to 30v16
  3. Site details revised at 2 of 29 sitesv15
  4. Study sites: 28 to 29v14
  5. Study sites: 26 to 28v13
  6. Study sites: 27 to 26v12
  7. Study sites: 25 to 27v11
  8. Eligibility criteria shortened, about 22 wordsv10
  9. Study sites: 24 to 25v9
  10. Site details revised at 1 of 24 sitesv8
  11. Study sites: 23 to 24v7
  12. Study sites: 21 to 23v6
  13. Study sites: 20 to 21v5
  14. Study sites: 18 to 20v4
  15. Study sites: 16 to 18v3
  16. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 2025 to Oct 22, 2025
    • Site details revised at 16 of 16 sites
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Phase 1a: Percentage of Participants with Dose Limited Toxicity (DLT) Toxicities
Timeframe: Cycle 1 (28 days)
Phase 1b: Objective Response Rate (ORR): Percentage of Participants with Best Response of Complete Response (CR) or Partial Response (PR)
Timeframe: Baseline through imaging follow-up, up to 5 years

Secondary (8)

Phase 1a: Absorbed Dose Estimates (Gy) in Normal Organs
Phase 1a and 1b: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4337713
Phase 1a and 1b: PK: Area Under the Concentration Time Curve (AUC) of LY4337713
Phase 1a: Objective Response Rate (ORR): Percentage of Participants with Best Response of Complete Response (CR) or Partial Response (PR)
Phase 1a and 1b: Number of Participants with Best Overall Response (BOR)
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Phase 1a and 1b: Duration of Response (DOR)
Phase 1a and 1b: Time to Response (TTR)
Phase 1a and 1b: Percentage of Participants with Disease Control Rate (DCR)

Arms and interventions

LY4337713 (Cohort A1)Experimental

Escalating doses of LY4337713 administered intravenously (IV).

LY4337713 (Cohort A2)Experimental

Two or more dose regimens of LY4337713 (evaluated during dose escalation) administered IV.

LY4337713 (Cohort B)Experimental

Tumor specific cohort will receive LY4337713 administered IV.

LY4337713 (Cohort C)Experimental

Tumor specific cohort will receive LY4337713 administered IV.

LY4337713 (Cohort D)Experimental

Tumor specific cohort will receive LY4337713 administered IV.

LY4337713 (Cohort E)Experimental

Tumor specific cohort will receive LY4337713 administered IV.

Drugs: LY4337713

Sites

30 sites in 5 countries

United States 20, Netherlands 6, Japan 2, China 1, Germany 1