Brief Title: ALE.P03 as Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Number of Patients with Dose Limiting Toxicities (DLTs) (Phase I)

Primary Outcome 1 - Timeframe: Up to 28 days

Primary Outcome 2 - Measure: Number of Patients with Adverse Events (Phase I)

Primary Outcome 2 - Timeframe: From Day 1 up to Safety follow-up (30 ± 5 days post last dose [Up to 4 years])

Primary Outcome 3 - Measure: Overall Response Rate (ORR) (Phase I)

Primary Outcome 3 - Timeframe: From ALE.P03 treatment initiation until at or prior to initiation of the use of new anti-cancer therapy (Up to 4 years)

Primary Outcome 4 - Measure: Duration of Response (DoR) (Phase I)

Primary Outcome 4 - Timeframe: From ALE.P03 treatment initiation until disease progression or study completion (Up to 4 years)

Primary Outcome 5 - Measure: Overall Response Rate (ORR) (Phase II)

Primary Outcome 5 - Timeframe: From ALE.P03 treatment initiation until at or prior to initiation of the use of new anti-cancer therapy (Up to 4 years)

Primary Outcome 6 - Measure: Duration of Response (DoR) (Phase II)

Primary Outcome 6 - Timeframe: From ALE.P03 treatment initiation until disease progression or study completion (Up to 4 years)

CONDITION

• Cervical Squamous Cell Carcinoma
• Squamous Non-small-cell Lung Cancer
• Colorectal Cancer
• Intrahepatic Cholangiocarcinoma
• Urothelial Carcinoma

ELIGIBILITY

Inclusion Criteria:
* 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.
Phase I Dose Escalation:
- Received and being refractory/intolerant to available systemic standard of care (SOC) regimens (based on local institutional guidelines) for advanced disease.
Phase I RDE and Phase II:
* Received 1-2 available systemic SOC regimens (based on local institutional guidelines) for advanced disease and being refractory or intolerant to treatment.

- * Patients with actionable oncogenic drivers: received feasible targeted therapy.
Applicable for Phase I Dose Escalation, Phase I RDE and Phase II:
* Measurable disease per RECIST 1.1, as determined by the site.

- * Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Groups Performance Status.

- * Demonstrate adequate bone marrow and organ function as per the protocol.
Exclusion Criteria:
* 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.

- * Has a history of (non-infectious) interstitial lung disease/pneumonitis that required steroids or current symptomatic or clinically significant pneumonitis requiring steroids and/or immunosuppressive therapies.

- * Has clinically significant gastrointestinal bleeding.

- * Has an active infection requiring systemic treatment.

- * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the clinical study.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: Alentis Clinical Trial Contact

Phone: +41782304288

Email: [email protected]

LOCATION