Solid TumorsPhase 1NCT07016997
A Phase I, First in Human Study of CBA-1535, T Cell Engager(5T4/CD3/5T4) in Patients With Advanced Solid Tumors.
A Phase 1 study testing CBA-1535 and CBA-1535+Pembrolizumab in people with Solid Tumors and Refractory Cancer, run by Chiome Bioscience Inc. at 2 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Solid Tumors, Refractory Cancer
- What is being tested?
- CBA-1535 and CBA-1535+Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesJapan
- Study dates
- 27 Jun 2022to Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Japan2 sites, 2 recruiting
- Recruiting
National Cancer Center Hospital
Chuo-Ku, Tokyo
- Recruiting
Shizuoka Cancer Center
Nagaizumicho, Shizuoka
About this study
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.
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.
Read the 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.
- Conditions
- Solid Tumors, Refractory Cancer
- Being tested
- CBA-1535, CBA-1535+Pembrolizumab
- Keywords
- CBA-1535, 5T4, CD3, T cell Engager, Trophoblast Glycoprotein, Tribody, solid tumors
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBA-1535Drug
Dosing is increased from 0.1 µg/body until DLT or disease progression occurs.
CBA-1535+PembrolizumabDrug
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 group | Role | What they receive |
|---|---|---|
| Part 1: CBA-1535 (single agent therapy) | Experimental | Patients will receive CBA-1535 as weekly IV infusion at escalated doses on Day 1, 8 and 15 of each 21-day cycle. Receives: Drug: CBA-1535 |
| Part 2: CBA-1535+Pembrolizumab | Experimental | Patients will receive CBA-1535 as weekly IV infusion at escalated doses on Day 1, 8 and 15 , and Pembrolizumab as Q3W IV infusion at fix dose on Day 1 of each 21-day cycle. Receives: Drug: CBA-1535+Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity
DLTs are assessed according to CTCAE v.5.0 during the first cycle (21 days).
Measured: Up to 21 days in Cycle 1
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.
Measured: Up to approximately 24 months
Secondary outcomes (2)
Serum CBA-1535 concentration
Blood samples are collected to assess the serum concentration of CBA-1535.
Measured: From Day 1 to Day 22
Efficacy in previously treated advanced solid Tumors.
Efficacy evaluation based on RECIST v.1.1 is performed by CT or MRI scan or others.
Measured: Up to approximately 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start27 Jun 2022
- Primary completion31 Dec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiome Bioscience Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07016997
- Sponsor's protocol ID
- 1535-001
- Other IDs
- jRCT2031210708
- Status last verified
- Jun 2025
- First submitted
- 7 Apr 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07016997
- Acronym / sponsor ID
- 1535-001
- Conditions
- Solid Tumors, Refractory Cancer
- Keywords
- CBA-1535, 5T4, CD3, T cell Engager, Trophoblast Glycoprotein, Tribody, solid tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Chiome Bioscience Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Jun 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 12 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1: CBA-1535 (single agent therapy) | Experimental | Drug: CBA-1535Patients will receive CBA-1535 as weekly IV infusion at escalated doses on Day 1, 8 and 15 of each 21-day cycle. |
| Part 2: CBA-1535+Pembrolizumab | Experimental | Drug: CBA-1535+PembrolizumabPatients will receive CBA-1535 as weekly IV infusion at escalated doses on Day 1, 8 and 15 , and Pembrolizumab as Q3W IV infusion at fix dose on Day 1 of each 21-day cycle. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBA-1535Dosing is increased from 0.1 µg/body until DLT or disease progression occurs. | Drug | Part 1: CBA-1535 (single agent therapy) |
| CBA-1535+PembrolizumabDrug：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 | Drug | Part 2: CBA-1535+Pembrolizumab |
Primary outcome
Dose limiting toxicity
Time frame: Up to 21 days in Cycle 1
DLTs are assessed according to CTCAE v.5.0 during the first cycle (21 days).
Adverse event
Time frame: 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.
2 secondary outcomes
Serum CBA-1535 concentration
Time frame: From Day 1 to Day 22
Efficacy in previously treated advanced solid Tumors.
Time frame: Up to approximately 24 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CBA-1535 and CBA-1535+Pembrolizumab in people with Solid Tumors and Refractory Cancer, run by Chiome Bioscience Inc. at 2 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chiome Bioscience Inc. (+81-3-6383-3561, ir@chiome.co.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity (time frame: Up to 21 days in Cycle 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.