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

ConditionsSolid TumorsRefractory Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age20+
SponsorChiome Bioscience Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Design model

Sequential

Treatments tested in this trial

  • CBA-1535

    Drug

    Dosing is increased from 0.1 µg/body until DLT or disease progression occurs.

  • CBA-1535+Pembrolizumab

    Drug

    Drug：CBA-1535 First Dosing will be determined by Part 1. And dosing will be increased until DLT or disease progression occurs. Drug：Pembrolizumab 200 mg/body

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Part 1: CBA-1535 (single agent therapy)Experimental treatment 1 intervention
Group B: Part 2: CBA-1535+PembrolizumabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

1

Serum CBA-1535 concentration

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

Time frame
From Day 1 to Day 22
2

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.

Other outcomes

Locations

2

Map coordinates are unavailable for these locations. Locations are shown below instead.

Shizuoka Cancer CenterRecruiting Nagaizumicho, ShizuokaJapanJapan
National Cancer Center HospitalRecruiting Chuo-Ku, TokyoJapanJapan

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chiome Bioscience Inc.

Lead sponsor

Source ClinicalTrials.gov
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