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

Condition(s) studied

Investigational drug(s) / intervention(s)

CBA-1535: Dosing is increased from 0.1 µg/body until DLT or disease progression occurs.

CBA-1535+Pembrolizumab: 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

Study 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.

Eligibility

Primary outcome measure(s)

• Dose limiting toxicity — Up to 21 days in Cycle 1
  DLTs are assessed according to CTCAE v.5.0 during the first cycle (21 days).
• Adverse event — Up to approximately 24 months
  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.

Trial sites (2)

More Chiome Bioscience Inc. trials in Japan

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