This is a Phase 1/1b Study to Evaluate the Safety and Preliminary Antitumor Activity of LTZ-232 in Participants With Advanced/Metastatic Colorectal Cancer and Other Solid Tumors

LTZ Therapeutics, Inc.

Status and phase: Enrolling; Phase 1

Conditions: Colon Cancer; Advanced/Metastatic Solid Tumor; Solid Tumor (Phase I); EPCAM; Colorectal Cancer

Treatments: Drug: LTZ-232

Study type: Interventional

Funder types: Industry

Identifiers

NCT07878988

LTZ-232-001

Details and patient eligibility

About

This is a first-in-human, Phase 1, multi-center, open-label study to characterize the safety, pharmacokinetics, pharmacodynamics, and preliminary anti tumor activity of LTZ-232 as monotherapy in adult participants with unresectable or metastatic colorectal cancer and other solid tumors failing standard therapies.

Full description

LTZ-232 is an engineered anti-EPCAM bispecific antibody designed to activate tumor-associated macrophages to phagocytose and kill tumor cells.

Enrollment: 152 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Advanced /metastatic colorectal tumors that have failed standard treatments
• Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
• Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 1
• Adequate organ function based on laboratory testing

Exclusion criteria

• Active infection with hepatitis B or C
• Uncontrolled CNS metastases
• Active autoimmune disease
• Clinically significant cardiovascular disease not adequately controlled with medication or impaired function
• Previous treatment with EpCAM targeting agent
• Pregnant or breast feeding
• Non-colorectal active malignancy within 3 years that could interfere with study interpretation

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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152 participants in 3 patient groups

Dose Escalation in metastatic colorectal cancer

Experimental group

Description:

Participants in this arm will participate in one (1) of up to eight (8) escalating defined dose level cohorts. Participants may receive LTZ-232 intravenously up to 24 months unless treatment discontinuation criteria are met.

Treatment:

Drug: LTZ-232

Safety/PK/Pharmacodynamic Cohorts

Experimental group

Description:

Participants may be dosed with LTZ-232 intravenously at levels previously declared safe to further explore safety and clinical activity at particular dose levels.

Treatment:

Drug: LTZ-232

Dose Expansion in metastatic colorectal cancer and other solid tumor types

Experimental group

Description:

Participants with unresectable or metastatic colorectal cancer and other specific solid tumor types at a LTZ-232 dosing regimen(s) identified from dose escalation.

Treatment:

Drug: LTZ-232