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

Chiome Bioscience Inc.

Status and phase: Enrolling; Phase 1

Conditions: Refractory Cancer; Solid Tumors

Treatments: Drug: CBA-1535+Pembrolizumab; Drug: CBA-1535

Study type: Interventional

Funder types: Industry

Identifiers

NCT07016997

1535-001

jRCT2031210708 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Part 1: CBA-1535 (single agent therapy)

Experimental group

Description:

Patients will receive CBA-1535 as weekly IV infusion at escalated doses on Day 1, 8 and 15 of each 21-day cycle.

Treatment:

Drug: CBA-1535

Part 2: CBA-1535+Pembrolizumab

Experimental group

Description:

Patients will receive CBA-1535 as weekly IV infusion at escalated doses on Day 1, 8 and 15 , and Pembrolizumab as Q3W IV infusion at fix dose on Day 1 of each 21-day cycle.

Treatment:

Drug: CBA-1535+Pembrolizumab