Clinical trial NCT07016997: A Phase I, First in Human Study of CBA-1535, T Cell Engager(5T4/CD3/5T4) in Patients With Advanced Solid Tumors.
Official title: A Phase I Study to Assess the Safety, Tolerability and Biomarker Profiles of CBA-1535, Recombinant Protein Tribody in Patients With Previously Treated Advanced Solid Tumors.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Solid Tumors
Refractory Cancer
Keywords: CBA-1535
5T4
CD3
T cell Engager
Trophoblast Glycoprotein
Tribody
solid tumors
Lead sponsor: Chiome Bioscience Inc.
Sponsor class: INDUSTRY
First posted: 2025-06-12
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Dose limiting toxicity
timeFrame: Up to 21 days in Cycle 1
measure: Adverse event
timeFrame: Up to approximately 24 months
Secondary outcomes:
measure: Serum CBA-1535 concentration
timeFrame: From Day 1 to Day 22
measure: Efficacy in previously treated advanced solid Tumors.
timeFrame: Up to approximately 24 months.
Other outcomes:
Locations:
city: Nagaizumicho
country: Japan
facility: Shizuoka Cancer Center
state: Shizuoka
city: Chuo-Ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
Study officials:
References: