NCT07016997 A Phase I, First in Human Study of CBA-1535, T Cell Engager(5T4/CD3/5T4) in Patients With Advanced Solid Tumors.
| NCT ID | NCT07016997 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Chiome Bioscience Inc. |
| Condition | Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2022-06-27 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 70 participants in total. It began in 2022-06-27 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07016997 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, studying Solid Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07016997 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07016997 currently recruiting?
Yes, NCT07016997 is actively recruiting participants. Contact the research team at ir@chiome.co.jp for enrollment information.
Where is the NCT07016997 trial being conducted?
This trial is being conducted at Nagaizumicho, Japan, Chuo-Ku, Japan.
Who is sponsoring the NCT07016997 clinical trial?
NCT07016997 is sponsored by Chiome Bioscience Inc.. The trial plans to enroll 70 participants.