CBA-1535 (5T4/CD3) T‑cell engager given alone and with pembrolizumab for 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.
Run by Chiome Bioscience Inc. · NCT07016997 · Data updated 2026-11-12
This trial tests whether CBA-1535, a T‑cell engager that targets 5T4, is safe and shows early signs of benefit when given alone or with pembrolizumab to people with advanced solid tumors who have no standard treatment options.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 20 Years and up |
| Sex | All |
| Enrollment | 70 (estimated) |
| Sponsor | Chiome Bioscience Inc. Industry-sponsored |
| Drugs / interventions | Pembrlizumab, pembrolizumab |
| Locations | 2 sites (Nagaizumicho, Shizuoka and 1 other locations) |
| Status | Recruiting |
| Started | June 27, 2022 |
| Main results expected | December 31, 2025 |
| Study ends | December 2026 |
| Registry record updated | June 12, 2025 |
| Trial ID | NCT07016997 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with advanced solid tumors who have no available standard therapy or are refractory/intolerant to standard treatment, with ECOG performance status 0–1 and an expected life expectancy of at least three months, are the intended candidates.
✕Probably not a fit
Patients with poor performance status (ECOG >1), recent exposure to other investigational or anti‑cancer agents within the required washout windows, known hypersensitivity to similar protein drugs, or tumors that lack the target antigen may not receive benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a first‑in‑human, multicenter, open‑label Phase I dose‑escalation program with two parts: Part 1 tests escalating doses of CBA‑1535 as a single agent and Part 2 tests escalating doses of CBA‑1535 combined with pembrolizumab. The study will enroll patients with advanced solid tumors who have exhausted or are intolerant of standard therapies. Primary endpoints focus on safety and tolerability, with secondary and exploratory endpoints including pharmacokinetics, biomarker profiles, and preliminary anti‑tumor activity. Dose escalation will define the recommended dose for subsequent studies.
Why it matters
Potential benefit: If successful, the drug could offer a new immunotherapy option that engages patients' T cells against 5T4‑expressing tumors, potentially shrinking cancers that no longer respond to standard treatments.
How similar studies have gone: Bispecific T‑cell engagers have produced strong results in blood cancers but only limited, early‑stage signals in solid tumors, and combining bispecifics with checkpoint inhibitors is an emerging approach with promising but not yet proven outcomes.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Shizuoka Cancer Center
Nagaizumicho, Shizuoka, Japan Recruiting -
National Cancer Center Hospital
Chuo-Ku, Tokyo, Japan Recruiting
Study contacts
- Study coordinator: Chiome Bioscience Inc.
- Email: ir@chiome.co.jp
- Phone: +81-3-6383-3561
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
BA1203 in advanced solid tumors: safety and early signs of activity
This early-phase trial tests BA1203 in adults with advanced solid tumors to see if it is safe, tolerable, how the drug behaves in the body, and whether it shows any early signs of effectiveness.
-
BL-M08D treatment in melanoma and other solid tumors
A phase Ib/II study tests BL-M08D1 injections in adults with locally advanced or metastatic melanoma and other solid tumors to see if it is safe and helpful.
-
REC-7735 for PIK3CA-H1047R-mutant solid tumors
This study tests REC-7735 in people with unresectable, locally advanced, or metastatic solid tumors that carry the PIK3CA-H1047R mutation.
-
Preferences of physicians and patients for cell therapies in advanced solid tumors
This study tests how doctors and patients weigh the benefits, risks, and burdens of CAR-T, TIL, TCR-T, and NK cell therapies in advanced solid cancers.
-
HP007 monotherapy for relapsed or advanced solid tumors
This study tests HP007 as a standalone treatment in adults with hard-to-treat solid tumors to see if it is safe and tolerable and to look for early signs of activity.
-
ONO-7429 in advanced or recurrent solid tumors
This small early-phase study tests whether ONO-7429 is tolerable and safe in adults with unresectable advanced or recurrent solid tumors who have tried other treatments.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.