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NCT06747585

A Study to Investigate ALE.P02 as a Monotherapy or in Combination With Pembrolizumab in Adult Patients With Selected CLDN1+ Solid Tumors

StatusRecruiting
PhasePhase 1/2
Primary completion (estimated)
Track this trial

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Record History

All 19 versions: 19 with changes below. See every version on ClinicalTrials.gov ↗

  1. Enrollment increased: 170 → 235 participants Show 7 more changesShow less
    • Interventions modified
    • Trial arms changed: 3 → 5
    • Eligibility criteria expanded, about 33 words
    • Secondary endpoints: details revised at 6 of 17 entries
    • Study description expanded, about 11 words
    • Site details revised at 2 of 41 sites
    • Study title expanded, about 6 words
  2. Trial sites expanded: 38 → 41 locationsv18
  3. Study sites: 33 to 38v17
  4. Study sites: 30 to 33v16
  5. Study sites: 27 to 30v15
Show 13 earlier versionsHide 13 earlier versions
  1. Study sites: 25 to 27v14
  2. Study sites: 24 to 25v13
  3. Study sites: 22 to 24v12
  4. Study sites: 20 to 22v11
  5. Study sites: 19 to 20v10
  6. Study sites: 13 to 19v9
  7. Study sites: 9 to 13v8
  8. Study sites: 7 to 9v7
  9. Study sites: 6 to 7v6
  10. Study sites: 5 to 6v5
  11. Study sites: 4 to 5v4
  12. Study sites: 3 to 4v3
  13. Study sites: 2 to 3v2
  1. Study First Submitted
  • Minor: routine updates

Endpoints

Primary

Number of Patients with Dose Limiting Toxicities (DLTs)
Timeframe: Up to 28 days
Number of Patients with Adverse Events
Timeframe: Screening (day -28 to day -1) up to Safety follow-up (30 ± 5 days post last dose [Up to 3.5 years])
Overall Response Rate (ORR) (Phase I)
Timeframe: From ALE.P02 treatment initiation until at or prior to initiation of the use of new anti-cancer therapy (Up to 3.5 years)
Duration of Response (DoR) (Phase I)
Timeframe: From ALE.P02 treatment initiation until disease progression or study completion (Up to 3.5 years)
Overall Response Rate (ORR) (Phase II)
Timeframe: From ALE.P02 treatment initiation until at or prior to initiation of the use of new anti-cancer therapy (Up to 3.5 years)
Duration of Response (DoR) (Phase II)
Timeframe: From ALE.P02 treatment initiation until disease progression or study completion (Up to 3.5 years)

Secondary (17)

Disease control rate (DCR) (Phase I and II)
Median Progression-Free Survival (PFS) at 6 and 12 Months (Phase I and II)
Median Overall Survival (OS) at 6, 12, and 24 Months (Phase I and II)
Blood Concentration of ALE.P02 Antibody-drug Conjugate (ADC)
Blood Concentration of Total Antibody
Show 12 moreShow less
Blood Concentrations of Payload
Area under the concentration-time curve over the dosing interval (AUCtau)
Area under the concentration-time curve from pre-dose (time 0) to the time of the last quantifiable concentration (AUClast)
Area under the concentration-time curve from pre-dose (time 0) extrapolated to infinite time (AUCinf)
Maximum Concentration (Cmax)
Minimum concentration (Cmin)
Concentration at the end of a Dosing Interval (Ctrough)
The terminal elimination rate constant (KeL)
Terminal elimination half-life (t½)
Time of Maximum Concentration (tmax)
Average Concentration (Cavg)
Number of Patients with Presence of anti-ALE.P02 Antibodies

Arms and interventions

Phase I Dose Escalation - ALE.P02Experimental

Patients will receive ALE.P02 as monotherapy via intravenous infusion. The ALE.P02 will be given at an escalated dose until Maximum tolerated dose (MTD) and/or a safe recommended Dose for Expansion (RDE) is determined in Phase I dose escalation part of the study.

Phase I Dose Expansion - ALE.P02Experimental

Patients will receive ALE.P02 as monotherapy via intravenous infusion. The safe recommended dose of ALE.P02 will be given in Phase I dose expansion part of the study to identify Recommended Phase II Dose (RP2D).

Phase II - ALE.P02Experimental

Patients will receive ALE.P02 as monotherapy via intravenous infusion at the RP2D, or according to the dosing schedule after the dose expansion phase.

Phase I Dose Escalation - ALE.P02 in combination with pembrolizumabExperimental

Patients will receive ALE.P02 in combination with pembrolizumab via intravenous infusion. The ALE.P02 will be given at an escalated dose until Maximum tolerated dose (MTD) and/or a safe recommended Dose for Expansion (RDE) is determined.

Phase I Dose Expansion - ALE.P02 in combination with pembrolizumabExperimental

Patients will receive ALE.P02 in combination with pembrolizumab via intravenous infusion. The safe recommended dose of ALE.P02 will be given in Phase I dose expansion part of the study.

Drugs: ALE.P02, Pembrolizumab

Sites

41 sites in 8 countries

Spain 9, United States 8, Italy 7, France 6, South Korea 4, Taiwan 4, Singapore 2, Hong Kong 1