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.P03 monotherapy in adult patients with selected squamous solid tumors.
Have histologically and cytologically metastatic confirmed advanced or metastatic colorectal cancer, intrahepatic cholangiocarcinoma, squamous non-small cell lung cancer, urothelial carcinoma, and cervical squamous cell carcinoma.
Have documented radiological disease progression at study entry.
Have provided tissue for CLDN1 (Claudin-1) analysis in a central laboratory.
Received 1-2 available systemic SOC regimens (based on local institutional guidelines) for advanced disease and being refractory or intolerant to treatment.
SqNSCLC and CSCC: diagnosed with a tumor of predominantly non-squamous histology result or adenocarcinoma.
Has received antineoplastic therapies prior to study intervention within specified time frame.
Has rapidly progressing disease.
Has known active central nervous system metastases and/or carcinomatous meningitis.
Sequential
ALE.P03
DrugALE.P03, will be administered by IV infusion according to the assigned arms.
ALE.P03
DrugALE.P03, will be administered by IV infusion according to the assigned arms.
ALE.P03
DrugALE.P03, will be administered by IV infusion according to the assigned arms.
Number of Patients with Dose Limiting Toxicities (DLTs) (Phase I)
DLTs as defined in the protocol will be assessed to evaluate safety and tolerability of ALE.P03 (Phase I Dose Escalation), and to establish RP2D for ALE.P03 (Phase I RDE).
Number of Patients with Adverse Events (Phase I)
Adverse events will be assessed to evaluate safety and tolerability of ALE.P03 (Phase I Dose Escalation), and to establish RP2D for ALE.P03 (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.P03 (Phase I RDE)
Duration of Response (DoR) (Phase I)
The DoR is defined for patients achieving a CR or PR as per Investigator review according to RECIST 1.1 to disease progression before new anti-cancer therapy or death of any cause, whichever occurs earlier. This is assessed to establish RP2D for ALE.P03 (Phase I RDE).
Number of Patients with Adverse Events (Phase I RDE and Phase II)
Adverse events will be assessed to evaluate safety and tolerability of ALE.P03 (Phase I RDE and Phase II)
Disease control rate (DCR) (Phase I and II)
The DCR is defined as the proportion of patients with a 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.P03 (Phase I and II).
Median Progression-Free Survival (PFS) rate 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.P03 (Phase I and II).
Median Overall Survival (OS) rate 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.P03 (Phase I and II).
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