A Phase I/II, Open-Label, Multi-Center Study of ALE.C04 (anti-Claudin-1 Antibody) as a Single Agent and in Combination with Pembrolizumab (anti-PD-1 antibody) in Adult Patients with Recurrent or Metastatic (R/M) Head and Neck Squamous Cell Carcinoma

Conditions

Recurrent or Metastatic (R/M) Head and Neck Squamous Cell Carcinoma

Brief summary

Incidence of DLTs, Incidence and severity of AEs, SAEs, Changes in laboratory values, vital signs, and ECGs, Tolerability: dose interruptions and dose intensity, To compare PFS per RECIST 1.1 by BICR, CLDN1 and PD-L1 subgroup analysis will be performed

Detailed description

Evaluated by investigators for both monotherapy and combination therapy: ORR, (ORR = CR rate + PR rate); iORR (iORR = iCR rate + iPR rate); DCR (DCR = CR rate + PR rate + SD rate); iDCR (iDCR=iCR rate + iPR rate + iSD rate); DOR and iDOR; PFS and iPFS (including rate at 6 and 12 months) per RECIST 1.1/iRECIST. Efficacy endpoints by BIRC in Phase II (randomized) CLDN1 and PD-L1 subgroup analysis will be performed., Overall Survival (OS) for both single agent and combination. Efficacy endpoints by BIRC in Phase II (randomized) CLDN1 and PD-L1 subgroup analysis will be performed, Serum concentrations of ALE.C04, PK parameters and exposure measures including, but not limited to, Cmax, Cmin, AUC, and other parameters as appropriate for ALE.C04, Pembrolizumab PK reported as concentration by time point, Measurement of anti-ALE.C04 antibodies and anti-pembrolizumab antibodies, eEORTC QLQ-C30 and EORTC QLQ-HN43

Related papers

No related papers found yet.

Interventions

DRUGALE.C04

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Incidence of DLTs, Incidence and severity of AEs, SAEs, Changes in laboratory values, vital signs, and ECGs, Tolerability: dose interruptions and dose intensity, To compare PFS per RECIST 1.1 by BICR, CLDN1 and PD-L1 subgroup analysis will be performed	—

Secondary

Measure	Time frame
Evaluated by investigators for both monotherapy and combination therapy: ORR, (ORR = CR rate + PR rate); iORR (iORR = iCR rate + iPR rate); DCR (DCR = CR rate + PR rate + SD rate); iDCR (iDCR=iCR rate + iPR rate + iSD rate); DOR and iDOR; PFS and iPFS (including rate at 6 and 12 months) per RECIST 1.1/iRECIST. Efficacy endpoints by BIRC in Phase II (randomized) CLDN1 and PD-L1 subgroup analysis will be performed., Overall Survival (OS) for both single agent and combination. Efficacy endpoints by BIRC in Phase II (randomized) CLDN1 and PD-L1 subgroup analysis will be performed, Serum concentrations of ALE.C04, PK parameters and exposure measures including, but not limited to, Cmax, Cmin, AUC, and other parameters as appropriate for ALE.C04, Pembrolizumab PK reported as concentration by time point, Measurement of anti-ALE.C04 antibodies and anti-pembrolizumab antibodies, eEORTC QLQ-C30 and EORTC QLQ-HN43	—

Measure

Time frame

Evaluated by investigators for both monotherapy and combination therapy: ORR, (ORR = CR rate + PR rate); iORR (iORR = iCR rate + iPR rate); DCR (DCR = CR rate + PR rate + SD rate); iDCR (iDCR=iCR rate + iPR rate + iSD rate); DOR and iDOR; PFS and iPFS (including rate at 6 and 12 months) per RECIST 1.1/iRECIST. Efficacy endpoints by BIRC in Phase II (randomized) CLDN1 and PD-L1 subgroup analysis will be performed., Overall Survival (OS) for both single agent and combination. Efficacy endpoints by BIRC in Phase II (randomized) CLDN1 and PD-L1 subgroup analysis will be performed, Serum concentrations of ALE.C04, PK parameters and exposure measures including, but not limited to, Cmax, Cmin, AUC, and other parameters as appropriate for ALE.C04, Pembrolizumab PK reported as concentration by time point, Measurement of anti-ALE.C04 antibodies and anti-pembrolizumab antibodies, eEORTC QLQ-C30 and EORTC QLQ-HN43

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Countries

France, Italy, Spain

Outcome results

None listed