The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic, preliminary anti-tumor activity, and to determine the recommended Phase II dose (RP2D) of the ALE.P02 monotherapy in adult patients with selected squamous solid tumors.
Have disease and treatment history as: Have histologically or cytologically confirmed advanced locally recurrent and inoperable or metastatic SqNSCLC, HNSCC (nasopharyngeal cancer included), ESCC or CSCC.
Phase I Dose Escalation: Have received at least one systemic standard of care regimen and being refractory or intolerant to the treatment.
Phase I RDE and Phase II: Have received no more than 2 lines of systemic standard of care regimen and being refractory or intolerant to the treatment.
Have provided tissue for CLDN1 analysis in a central laboratory.
Diagnosed with cancers of predominantly non-squamous histology (eg, adenosquamous carcinoma) or adenocarcinoma.
Has received antineoplastic therapies prior to study intervention within specified time frame.
Has rapidly progressing disease (eg, tumor bleeding, uncontrolled tumor pain).
Patients with uncontrolled diabetes.
Sequential
ALE.P02
DrugALE.P02, will be administered by IV infusion according to the assigned arms.
Number of Patients with Dose Limiting Toxicities (DLTs)
DLTs as defines in the protocol will be assessed to evaluate safety and tolerability of ALE.P02 (Phase I Dose Escalation), and to establish RP2D for ALE.P02 (Phase I RDE).
Number of Patients with Adverse Events
Adverse events will be assessed to evaluate safety and tolerability of ALE.P02 (Phase I Dose Escalation), and to establish RP2D for ALE.P02 (Phase I RDE).
Overall Response Rate (ORR) (Phase I)
The ORR is the proportion of patients with a best overall response (BOR) of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1.) This is assessed to establish RP2D for ALE.P02 (Phase I RDE)
Duration of Response (DoR) (Phase I)
The DoR is defined for patients achieving a confirmed CR or PR as the time from the initial response of CR or PR per Investigator review according to RECIST 1.1 to disease progression or death of any cause, whichever occurs earlier. This is assessed to establish RP2D for ALE.P02 (Phase I RDE).
Disease control rate (DCR) (Phase I and II)
The DCR is defined as the proportion of patients with a confirmed BOR of CR or PR or stable disease (SD) per Investigator review according to RECIST 1.1 at or prior to initiation of the use of new anti-cancer therapy. This is assessed to evaluate preliminary evidence of anti-tumor activity of ALE.P02 (Phase I and II).
Median Progression-Free Survival (PFS) at 6 and 12 Months (Phase I and II)
The PFS is defined as time from first study treatment to a documented disease progression according to RECIST 1.1, as determined by the Investigator, or death due to any cause, whichever occurs earlier. This is assessed to evaluate preliminary evidence of anti-tumor activity of ALE.P02 (Phase I and II).
Median Overall Survival (OS) at 6, 12, and 24 Months (Phase I and II)
The OS is defined as time from first study treatment to death due to any cause. This is assessed to evaluate preliminary evidence of anti-tumor activity of ALE.P02 (Phase I and II).
Blood Concentration of ALE.P02 Antibody-drug Conjugate (ADC)
Concentrations of ALE.P02 ADC in blood will be measured at each scheduled time point per arms to assess the pharmacokinetic (PK) profile of ALE.P02.
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