A Phase I, First in Human Study of CBA-1535, T Cell Engager(5T4/CD3/5T4) in Patients With Advanced Solid Tumors.

Phase 1RecruitingNCT07016997

Chiome Bioscience Inc.70 enrolled

Overview

This is a First in Human muticenter, non-randomized, open-label Phase I dose-escalation study of CBA-1535. The study will have 2 parts (Part 1 and Part 2). Part 1 is the dose-escalation cohorts of CBA-1535 single agent theapy. Part 2 is the dose-escalation cohorts of CBA-1535 in combination with Pembrlizumab. This study will evaluate the safety, tolerability, PK, biomarker profiles and preliminary efficacy of CBA-1535.

To evaluate safety and efficacy of CBA-1535 in the following two parts in a stepwise manner: Part 1 \- In Part 1, the primary objective is to evaluate the safety and tolerability of CBA-1535 in patients with solid tumors where no standard treatment is available, or who are intolerant to or non-responders to standard treatments. Additionally, the PK, biomarker profiles, and preliminary efficacy will be evaluated. The initial dose for Part 2 will also be determined. Part 2 \- In Part 2, The primary objective is to evaluate the safety and tolerability of CBA-1535 in combination with pembrolizumab in patients with solid tumor where no standard treatment is available, or who are intolerable or non-responder to the standard treatment. Additionally, the PK, biomarker profiles, preliminary efficacy will be evaluated. The recommended Phase 2 dose (R2PD) will also be determined.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Solid Tumors

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients who provide voluntary written informed consent to participate in the study * ECOG performance status: \<= 1 * Patients with 3 months or longer life expectancy * Patients with solid tumors for whom no standard therapy is available or who are refractory to or intolerant of standard therapy Exclusion Criteria: * Patients who received other investigational drug or antibody drugs, including immune checkpoint inhibitor within 28 days prior to enrollment * Patients who received anti-cancer drug within 14 days prior to enrollment * Patients with previous or suspected hypersensitivity to protein preparations such as therapeutic antibodies (Chinese hamster ovary cell-derived drugs) or any component of the study drug

Outcomes

Primary Outcomes

Dose limiting toxicity

DLTs are assessed according to CTCAE v.5.0 during the first cycle (21 days).

Time frame: Up to 21 days in Cycle 1

Adverse event

An adverse event is any untoward or unintended sign, symptom, or disease in a subject administered an investigational product, regardless of whether or not it is related to the investigational product.

Time frame: Up to approximately 24 months

Secondary Outcomes

Serum CBA-1535 concentration

Blood samples are collected to assess the serum concentration of CBA-1535.

Time frame: From Day 1 to Day 22

Efficacy in previously treated advanced solid Tumors.

Efficacy evaluation based on RECIST v.1.1 is performed by CT or MRI scan or others.

Time frame: Up to approximately 24 months.