A Phase I/II, Open-Label, Multi-Center Study of ALE.C04 (anti Claudin1 Antibody) as a Single Agent and in Combination with Pembrolizumab (anti-PD-1 antibody) in Adult Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Cancer Categories

Karmanos Trial ID

NCT ID

Age Group

Scope

Phase

Principal Investigator

Primary Objectives:

To evaluate safety and tolerability of ALE.C04 as monotherapy and in combination with pembrolizumab (Phase I Dose Escalation)
To establish RP2D for ALE.C04 in combination with pembrolizumab (Phase I RDEs)
To assess anti-tumor activity of ALE.C04 monotherapy (Phase II)
To establish RP2D of ALE.C04 monotherapy (Phase II)
To compare anti-tumor efficacy of ALE.C04 in combination with pembrolizumab versus pembrolizumab monotherapy (Phase II)

Secondary Objectives:

To assess the preliminary antitumor activity of ALE.C04 as monotherapy and in combination with pembrolizumab by evaluating tumor response (Phase I and Phase II)
To characterize the PK of ALE.C04 following a single dose administration and at steady state after multiple dosing as monotherapy and in combination with pembrolizumab (Phase I and Phase II)
To evaluate the immunogenicity of ALE.C04 as monotherapy and in combination with pembrolizumab (Phase I and Phase II)
Patient Reported Outcomes (Phase II, randomized)

Eligibility

Inclusion Criteria:

Be willing and able to provide written informed consents
Be 18 years of age on day of signing informed consent.
Have histologically or cytologically confirmed Recurrent or Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC) that is considered incurable by local therapies.
Have provided tissue for claudin-1 (CLDN1), programmed death ligand-1 (PD-L1) and biomarker analysis in a central Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory.
Have measurable disease based on RECIST 1.1 as determined by the site.
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
Have results from testing of human papillomavirus (HPV) status for oropharyngeal cancer

Exclusion Criteria:

Has progressive disease (PD) within 6 months of completion of curatively intended systemic treatment for locoregionally advanced HNSCC (Phase II randomized combination part only).
Has had radiation therapy (or other non-systemic therapy) within 2 weeks prior to randomization or patient has not fully recovered (i.e., ≤Grade 1 or at baseline) from adverse events due to a previously administered treatment. Palliative radiotherapy to a limited field is allowed.
Severe immune-related adverse events leading to discontinuation of prior immune-oncology agent only for Phase I dose escalation monotherapy and combination and Phase II monotherapy.
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Dermatological conditions requiring active pharmacological treatment including psoriasis, atopic dermatitis, excessively dry skin or recurrent conjunctivitis, scleroderma, vitiligo, or any other active autoimmune dermatological disorder.
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the clinical study, interfere with the patient's participation for the full duration of the clinical study, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.
Has received prior therapy with an anti-programmed death (PD)-1, anti-PD-L1 or anti-PD-L2 (Phase II randomized combination part only).

Locations

4100 John R
Detroit, MI 48201
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Phone: 800-527-6266

31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone: 800-527-6266

Applicable Disease Site

Therapies, Drugs, Devices