Solid TumorsPhase 1NCT06636435
A Phase I, First in Human Study of CBA-1205, Anti-DLK1 Monoclonal Antibody in Patients With Advanced Solid Tumors, Hepatocellular Carcinoma (HCC), Melanoma, and Pediatric Cancer
A Phase 1 study testing CBA-1205 Part 1, CBA-1205 Part 2 and CBA-1205 Part 3 in people with Solid Tumors and Hepatocellular Carcinoma (HCC), run by Chiome Bioscience Inc. at 5 sites in Japan.
Trial summary
In this first-in-human, muticenter, non-randomized, open-label, standard 3+3 dose escalation Phase I study encompasses 5 parts (Part 1-5). The purpose of this FIH study is to evaluate the safety and tolerability profile of CBA-1205. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Solid Tumors, Hepatocellular Carcinoma (HCC), Malignant Melanoma
- What is being tested?
- CBA-1205 Part 1, CBA-1205 Part 2 and CBA-1205 Part 3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 5 sitesJapan
- Study dates
- 1 Jun 2020to 30 Jun 2027
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who provide voluntary written informed consent to participate in the study
- Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of≤1
- Patients with preserved renal function as evidenced by laboratory data obtained within 7 days before enrollment (creatinine: ≤ ULN ×1.5)
- Patients who meet the following laboratory criteria of bone marrow function as evidenced by laboratory data obtained within 7 days before enrollment: Neutrophil count;≥1500/μL, Platelet count; ≥75000/μL, Hemoglobin;≥9.0 g/dL.
- Patients having Solid Tumors with no standard therapy available or refractory or intolerable to standard therapy (Part2, 3)
- Patients with Child-Pugh A or B (Part2, 3)
Show all 12Show fewer
- Patients with Malignant Melanoma who are refractory or intolerant to standard therapy (Part 4)
- Patients who provide voluntary written informed consent to participate in the study from both the subject (if aged 16 years or older) and their legal representatives
- Japanese patients aged 2 years or older and under 20 years at the time of informed consent
- Patients with a Lansky Performance Status (LPS) of ≥70 (for patients aged 15 years or younger) or a Karnofsky Performance Status (KPS) of ≥70 (for patients aged 16 years or older)
- Patients with preserved renal function as evidenced by laboratory data obtained within 7 days before enrollment (eGFR ≥60 mL/min/1.73 m²)
- Pediatric patients with cancers with no standard therapy available or refractory or intolerable to the standard therapy
Who cannot join
- Patients who have undergone major surgery within 28 days before enrollment
- Patients who have received anticancer treatment with surgical therapy, radiation therapy, and/or drug therapy within 14 days before enrollment
- Patients who have received anticancer treatment with immune checkpoint inhibitor, etc. within 28 days before enrollment
- Patients with Grade 2 or higher concurrent disease or prior therapy-related toxicity
- Patients who have received any other investigational product within 28 days before enrollment
- Patients with current or previous inadequately controlled or clinically significant cardiac disease
- Patients who, in the opinion of the investigator or subinvestigator, is not appropriate
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
General Affairs and Human Resources Department Chiome Bioscience Inc. contact
5 sites in 1 country
Japan5 sites, 5 recruiting
- Recruiting
National Cancer Center Hospital
Chūō, Tokyo, 104-0045
- Recruiting
University of Yamanashi Hospital
Chūō, Yamanashi, 409-3898
- Recruiting
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577
- Recruiting
Niigata University Medical and Dental Hospital
Niigata, Niigata, 951-8520
- Recruiting
Kanagawa Cancer Center
Yokohama, Kanagawa, 241-8515
About this study
Official title: A Phase I, First in Human Study of CBA-1205, Anti-DLK1 Monoclonal Antibody in Patients With Advanced Solid Tumors.
In this first-in-human, muticenter, non-randomized, open-label, standard 3+3 dose escalation Phase I study encompasses 5 parts (Part 1-5). The purpose of this FIH study is to evaluate the safety and tolerability profile of CBA-1205.
Read the detailed description
To evaluate safety and efficacy of CBA-1205 in the following five parts in a stepwise manner:
Part 1
- In Part 1, safety and tolerability in patients with Solid Tumor where no standard treatment is available, or who are intolerable or non-responder to the standard treatment will be evaluated. Initial dose for Part 2 will be determined.
Part 2
- In Part 2, safety and tolerability in patients with advanced and/or recurrent Hepatocellular Carcinoma which are unresectable, or who are intolerable or non-responder to the standard treatment will be evaluated. Recommended dose in this population will be determined.
Part 3
- In Part 3, safety and efficacy at the recommended dose in patients with advanced and/or recurrent Hepatocellular Carcinoma which are unresectable, or who are intolerable or non-responder to the standard treatment will be evaluated.
Part 4
- In Part 4, safety and efficacy in patients with Malignant Melanoma who are refractory or intolerant to standard therapy.
Part 5
- In Part 5, safety, tolerability and the recommended dose of the study drug in patients with Pediatric Cancer where no standard treatment is available, or who are intolerable or non-responder to the standard treatment will be evaluated.
PK analysis
- Being tested
- CBA-1205 Part 1, CBA-1205 Part 2, CBA-1205 Part 3, CBA-1205 Part 4, CBA-1205 Part 5
- Keywords
- DLK1, First in human, Phase I, Antibody, solid tumor, Hepatocellular Carcinoma, CBA-1205, Melanoma, Pediatric Cancer
- Medical subject headings
- Carcinoma, Hepatocellular, Melanoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBA-1205 Part 1Drug
CBA-1205: 0.1, 0.3, 1, 3, 10, 20, 30 mg/kg (Intravenous solution)
CBA-1205 Part 2Drug
CBA-1205: 20 mg/kg and 30 mg/kg (Intravenous solution)
CBA-1205 Part 3Drug
CBA-1205: 30 mg/kg (Intravenous solution)
CBA-1205 Part 4Drug
CBA-1205: 20 mg/kg (Intravenous solution)
CBA-1205 Part 5Drug
CBA-1205: 10 mg/kg (The initial cohort, Intravenous solution)
| Study group | Role | What they receive |
|---|---|---|
| CBA-1205: Part 1 | Experimental | CBA-1205 injection is administered at 2-week intervals in seven cohorts (0.1, 0.3, 1, 3, 10, 20, 30 mg/kg) in patients with solid tumor.
Note: In the study treatment period, CBA-1205 is intravenously administered at 2-week intervals in a 28-day cycle. Receives: Drug: CBA-1205 Part 1 |
| CBA-1205: Part 2 | Experimental | CBA-1205 (20, 30 mg/kg) injection is administered at 2-week intervals in 28-day cycles in patients with HCC .
Note: The study drug is administered at 2-week intervals until any of the criteria for discontinuation of study treatment are met. Receives: Drug: CBA-1205 Part 2 |
| CBA-1205: Part 3 | Experimental | CBA-1205 injection is administered at 2-week intervals in 28-day cycles in patients with HCC.
Note: The study drug is administered at 2-week intervals until any of the criteria for discontinuation of study treatment are met. Receives: Drug: CBA-1205 Part 3 |
| CBA-1205 : Part 4 | Experimental | CBA-1205 injection is administered at 2-week intervals in 28-day cycles in patients with Malignant Melanoma.
Note: The study drug is administered at 2-week intervals until any of the criteria for discontinuation of study treatment are met. Receives: Drug: CBA-1205 Part 4 |
| CBA-1205: Part 5 | Experimental | CBA-1205 injection is administered at 2-week intervals in 28-day cycles in patients with Pediatric Cancer.
Note: The study drug is administered at 2-week intervals until any of the criteria for discontinuation of study treatment are met. Receives: Drug: CBA-1205 Part 5 |
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 (28 days).
Measured: Part 1, 2 and 5 - Dose limiting toxicity : For 28 days after the first dose of study treatment
Adverse Event
An adverse event is any untoward or unintended sign, symptom, or disease in a subject administered an investigational product, whether or not it is related to the investigational product
Measured: Adverse event : Maximum 12 months
Secondary outcomes (3)
Serum CBA-1205 concentration
Blood samples are collected to assess the serum concentration of CBA-1205.
Measured: From Day 1 to Day 43 (or until Discontiuation of treatment)
Immunogenicity
Blood samples are collected to assess the serum anti-CBA-1205 antibody.
Measured: From Day1 to Day 43 (or until Discontiuation of treatment)
Efficacy
Antitumor response evaluated in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Tumor markers
Measured: Screening, Day 1 of Cycle 2 and 3, and Day 1 of even-numbered cycles from Cycle 4 onward until treatment discontinuation. Maximum 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start1 Jun 2020
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 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
- NCT06636435
- Sponsor's protocol ID
- 1205-001
- Other IDs
- jRCT2080225288
- Status last verified
- Jun 2026
- First submitted
- 30 Sep 2024
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nakamura K, Takahashi K, Sakaguchi I, Satoh T, Zhang L, Yanai H, Tsukumo Y. A Novel Glycoengineered Humanized Antibody Targeting DLK1 Exhibits Potent Anti-Tumor Activity in DLK1-Expressing Liver Cancer Cell Xenograft Models. Int J Mol Sci. 2024 Dec 19;25(24):13627. doi: 10.3390/ijms252413627.
PubMed 39769389Katsuya Y, Ikeda M, Koyama T, Sato J, Okada M, Matsubara N, Kondoh C, Mukohara T, Watanabe K, Kotani D, Ogawa Y, Taoka S, Yamamoto N. A Phase I, First-In-Human Study of CBA-1205, an Anti-DLK1 Monoclonal Antibody, in Patients With Advanced Solid Tumors. Cancer Sci. 2025 Apr;116(4):1012-1022. doi: 10.1111/cas.16454. Epub 2025 Jan 20.
PubMed 39832211
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, First in Human Study of CBA-1205, Anti-DLK1 Monoclonal Antibody in Patients With Advanced Solid Tumors.
- ClinicalTrials.gov ID
- NCT06636435
- Acronym / sponsor ID
- 1205-001
- Keywords
- DLK1, First in human, Phase I, Antibody, solid tumor, Hepatocellular Carcinoma, CBA-1205, Melanoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Chiome Bioscience Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 10 Oct 2024 (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.
In this first-in-human, muticenter, non-randomized, open-label, standard 3+3 dose escalation Phase I study encompasses 5 parts (Part 1-5). The purpose of this FIH study is to evaluate the safety and tolerability profile of CBA-1205.
Detailed description
To evaluate safety and efficacy of CBA-1205 in the following five parts in a stepwise manner:
Part 1
- In Part 1, safety and tolerability in patients with Solid Tumor where no standard treatment is available, or who are intolerable or non-responder to the standard treatment will be evaluated. Initial dose for Part 2 will be determined.
Part 2
- In Part 2, safety and tolerability in patients with advanced and/or recurrent Hepatocellular Carcinoma which are unresectable, or who are intolerable or non-responder to the standard treatment will be evaluated. Recommended dose in this population will be determined.
Part 3
- In Part 3, safety and efficacy at the recommended dose in patients with advanced and/or recurrent Hepatocellular Carcinoma which are unresectable, or who are intolerable or non-responder to the standard treatment will be evaluated.
Part 4
- In Part 4, safety and efficacy in patients with Malignant Melanoma who are refractory or intolerant to standard therapy.
Part 5
- In Part 5, safety, tolerability and the recommended dose of the study drug in patients with Pediatric Cancer where no standard treatment is available, or who are intolerable or non-responder to the standard treatment will be evaluated.
PK analysis
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| CBA-1205: Part 1 | Experimental | Drug: CBA-1205 Part 1CBA-1205 injection is administered at 2-week intervals in seven cohorts (0.1, 0.3, 1, 3, 10, 20, 30 mg/kg) in patients with solid tumor. Note: In the study treatment period, CBA-1205 is intravenously administered at 2-week intervals in a 28-day cycle. |
| CBA-1205: Part 2 | Experimental | Drug: CBA-1205 Part 2CBA-1205 (20, 30 mg/kg) injection is administered at 2-week intervals in 28-day cycles in patients with HCC . Note: The study drug is administered at 2-week intervals until any of the criteria for discontinuation of study treatment are met. |
| CBA-1205: Part 3 | Experimental | Drug: CBA-1205 Part 3CBA-1205 injection is administered at 2-week intervals in 28-day cycles in patients with HCC. Note: The study drug is administered at 2-week intervals until any of the criteria for discontinuation of study treatment are met. |
| CBA-1205 : Part 4 | Experimental | Drug: CBA-1205 Part 4CBA-1205 injection is administered at 2-week intervals in 28-day cycles in patients with Malignant Melanoma. Note: The study drug is administered at 2-week intervals until any of the criteria for discontinuation of study treatment are met. |
| CBA-1205: Part 5 | Experimental | Drug: CBA-1205 Part 5CBA-1205 injection is administered at 2-week intervals in 28-day cycles in patients with Pediatric Cancer. Note: The study drug is administered at 2-week intervals until any of the criteria for discontinuation of study treatment are met. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Patients who provide voluntary written informed consent to participate in the study
- Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of≤1
- Patients with preserved renal function as evidenced by laboratory data obtained within 7 days before enrollment (creatinine: ≤ ULN ×1.5)
- Patients who meet the following laboratory criteria of bone marrow function as evidenced by laboratory data obtained within 7 days before enrollment: Neutrophil count;≥1500/μL, Platelet count; ≥75000/μL, Hemoglobin;≥9.0 g/dL.
- Patients having Solid Tumors with no standard therapy available or refractory or intolerable to standard therapy (Part2, 3)
Key exclusion criteria (7 listed)
- Patients who have undergone major surgery within 28 days before enrollment
- Patients who have received anticancer treatment with surgical therapy, radiation therapy, and/or drug therapy within 14 days before enrollment
- Patients who have received anticancer treatment with immune checkpoint inhibitor, etc. within 28 days before enrollment
- Patients with Grade 2 or higher concurrent disease or prior therapy-related toxicity
- Patients who have received any other investigational product within 28 days before enrollment
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-1205 Part 1CBA-1205: 0.1, 0.3, 1, 3, 10, 20, 30 mg/kg (Intravenous solution) | Drug | CBA-1205: Part 1 |
| CBA-1205 Part 2CBA-1205: 20 mg/kg and 30 mg/kg (Intravenous solution) | Drug | CBA-1205: Part 2 |
| CBA-1205 Part 3CBA-1205: 30 mg/kg (Intravenous solution) | Drug | CBA-1205: Part 3 |
| CBA-1205 Part 4CBA-1205: 20 mg/kg (Intravenous solution) | Drug | CBA-1205 : Part 4 |
| CBA-1205 Part 5CBA-1205: 10 mg/kg (The initial cohort, Intravenous solution) | Drug | CBA-1205: Part 5 |
Primary outcome
Dose limiting toxicity
Time frame: Part 1, 2 and 5 - Dose limiting toxicity : For 28 days after the first dose of study treatment
DLTs are assessed according to CTCAE v.5.0 during the first cycle (28 days).
Adverse Event
Time frame: Adverse event : Maximum 12 months
An adverse event is any untoward or unintended sign, symptom, or disease in a subject administered an investigational product, whether or not it is related to the investigational product
3 secondary outcomes
Serum CBA-1205 concentration
Time frame: From Day 1 to Day 43 (or until Discontiuation of treatment)
Immunogenicity
Time frame: From Day1 to Day 43 (or until Discontiuation of treatment)
Efficacy
Time frame: Screening, Day 1 of Cycle 2 and 3, and Day 1 of even-numbered cycles from Cycle 4 onward until treatment discontinuation. Maximum 12 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 17 Jun 2026.
- Background: PubMed 39769389Nakamura K, Takahashi K, Sakaguchi I, Satoh T, Zhang L, Yanai H, Tsukumo Y. A Novel Glycoengineered Humanized Antibody Targeting DLK1 Exhibits Potent Anti-Tumor Activity in DLK1-Expressing Liver Cancer Cell Xenograft Models. Int J Mol Sci. 2024 Dec 19;25(24):13627. doi: 10.3390/ijms252413627.
- Results publication: PubMed 39832211Katsuya Y, Ikeda M, Koyama T, Sato J, Okada M, Matsubara N, Kondoh C, Mukohara T, Watanabe K, Kotani D, Ogawa Y, Taoka S, Yamamoto N. A Phase I, First-In-Human Study of CBA-1205, an Anti-DLK1 Monoclonal Antibody, in Patients With Advanced Solid Tumors. Cancer Sci. 2025 Apr;116(4):1012-1022. doi: 10.1111/cas.16454. Epub 2025 Jan 20.
- Sponsor PageLink provided by the sponsor.
- 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.
General Affairs and Human Resources Department Chiome Bioscience Inc. contact
5 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-1205 Part 1, CBA-1205 Part 2 and CBA-1205 Part 3 in people with Solid Tumors and Hepatocellular Carcinoma (HCC), run by Chiome Bioscience Inc. at 5 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 12 inclusion and 7 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 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 Tanaka Miseri 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: Part 1, 2 and 5 - Dose limiting toxicity : For 28 days after the first dose of study treatment). 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?
On the ClinicalTrials.gov record for NCT06636435, which also lists 2 linked publications.
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 17 Jun 2026.