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NCT06561685

A Study of LY4050784 in Participants With Advanced or Metastatic Solid Tumors

StatusActive, Not Recruiting
PhasePhase 1
Primary completion (estimated)
Track this trial

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Record History

All 27 versions: 27 with changes below. See every version on ClinicalTrials.gov ↗

  1. Enrollment closed, study ongoing
    • Site details revised at 32 of 32 sites
  2. Eligibility criteria expanded, about 21 words
    • Primary endpoints: details revised at 3 of 5 entries
    • Study sites: 33 to 32
  3. Site details revised at 1 of 33 sitesv25
  4. Site details revised at 3 of 33 sitesv24
  5. Study sites: 31 to 33v23
Show 21 earlier versionsHide 21 earlier versions
  1. Study sites: 33 to 31v22
  2. Site details revised at 1 of 33 sitesv21
  3. Study sites: 23 to 33v20
  4. Primary and study completion dates: Dec 2028 to Oct 2027v19
  5. Primary and study completion dates: Oct 2027 to Dec 2028
    • Study sites: 22 to 23
    v18
  6. Study sites: 23 to 22v17
  7. Study sites revised (23)v16
  8. Study sites revised (23)v15
  9. Site details revised at 6 of 23 sitesv14
  10. Study completion date: May 2028 to Oct 2027
    • Start date: Dec 13, 2024 to Sep 19, 2024
    v13
  11. Study sites: 22 to 23v12
  12. Site contacts updated at 22 of 22 sitesv11
  13. Enrollment target: 160 to 340v10 Show 8 more changesShow less
    • Start date: Sep 19, 2024 to Dec 13, 2024
    • Eligibility criteria expanded, about 79 words
    • Primary endpoints: 4 to 5
    • Study completion date: Oct 2027 to May 2028
    • Interventions: LY4050784 (Drug) to Carboplatin (Drug), Cisplatin (Drug), LY4050784 (Drug), Nab paclitaxel (Drug), Paclitaxel (Drug), Pembrolizumab (Drug), Pemetrexed (Drug)
    • Secondary endpoints: 8 to 11
    • Site details revised at 8 of 22 sites
    • Study arms: 3 to 6
  14. Study sites: 21 to 22v9
  15. Study sites: 20 to 21v8
  16. Study sites: 3 to 20v7
  17. Study sites: 2 to 3v6
  18. Study sites: 1 to 2v5
  19. Collaborators shortened, about 3 wordsv4
  20. Study Status, Referencesv3
  21. Trial status: Not Yet Recruiting to Recruiting
    • Eligibility criteria expanded, about 7 words
    • Start date changed from estimate of Aug 2024 to Sep 19, 2024
    • Site details revised
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Phase Ia: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs), Serious Adverse Event(s) (SAEs), and Adverse Event(s) (AEs)
Timeframe: Up to Approximately 48 Months or 4 Years
Phase 1a: To determine the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of LY4050784
Timeframe: Up to Approximately 48 Months or 4 Years
Phase 1b: To assess the antitumor activity of LY4050784 Monotherapy: Overall response rate (ORR)
Timeframe: Up to Approximately 48 Months or 4 Years
Phase 1b (Dose optimization only): To confirm the RP2D/optimal dose based on safety and efficacy of LY4050784
Timeframe: Up to Approximately 48 Months or 4 Years
Phase 1b (Combination cohorts/Part C): To assess the safety and tolerability of LY4050784 when administered in combination with other anticancer agents
Timeframe: Up to Approximately 48 Months or 4 Years

Secondary (11)

To characterize the pharmacokinetics (PK) properties of LY4050784: Maximum Concentration (Cmax)
To characterize the PK properties of LY4050784: Time to Maximum Concentration (Tmax)
To characterize the PK properties of LY4050784: Area under the concentration versus time curve (AUC)
Phase Ia: To evaluate the preliminary antitumor activity of LY4050784: Overall response rate (ORR)
To evaluate the preliminary antitumor activity of LY4050784: Duration of response (DOR)
Show 6 moreShow less
To evaluate the preliminary antitumor activity of LY4050784: Time to response (TTR)
To evaluate the preliminary antitumor activity of LY4050784: Disease control rate (DCR)
To evaluate the preliminary antitumor activity of LY4050784: Progression free survival (PFS)
To evaluate the PK properties of LY4050784 in combination cohorts: Maximum Concentration (Cmax) PK: Cmax of LY4050784
To evaluate the PK properties of LY4050784 in combination cohorts: Time to Maximum Concentration (Tmax) PK: Tmax of LY4050784
To evaluate the PK properties of LY4050784 in combination cohorts: Area under the concentration versus time curve (AUC)

Arms and interventions

LY4050784 (Phase 1a - Dose Escalation)Experimental

Escalating doses of LY4050784 administered orally.

LY4050784 (Phase 1b - Dose Optimization/Part A)Experimental

Comparing 2 or more doses (evaluated during dose escalation) of LY4050784 administered orally.

LY4050784 (Phase 1b - Dose Expansion/Part B)Experimental

LY4050784 administered orally.

LY4050784 (Phase 1b - Dose Expansion/Part C) Cohort C1Experimental

LY4050784 administered orally in combination in combination with pembrolizumab administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.

LY4050784 (Phase 1b - Dose Expansion/Part C) Cohort C2aExperimental

LY4050784 administered orally in combination in combination with pembrolizumab, pemetrexed, and platinum (cisplatin or carboplatin) administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.

LY4050784 (Phase 1b - Dose Expansion/Part C) Cohort C2bExperimental

LY4050784 administered orally in combination in combination with pembrolizumab, paclitaxel/nab-paclitaxel and carboplatin administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.

Drugs: LY4050784, Pembrolizumab, Cisplatin, Carboplatin, Pemetrexed, Paclitaxel, Nab paclitaxel

Sites

32 sites in 6 countries

United States 17, Japan 4, France 3, Germany 3, South Korea 3, Spain 2