Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

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 I, First in Human Study of CBA-1205, Anti-DLK1 Monoclonal Antibody in Patients With Advanced Solid Tumors.

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 (NCT06636435) is a Phase 1 interventional studying Solid Tumors and Hepatocellular Carcinoma (HCC), sponsored by Chiome Bioscience INC.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Solid Tumors, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 66 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Solid Tumors subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify:(Part 1-4) - Patients who provide voluntary written willing to sign a consent form 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) - Patients with Malignant Melanoma who are refractory or intolerant to standard therapy (Part 4) Who May Qualify:(Part 5) - Patients who provide voluntary written willing to sign a consent form 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 willing to sign a consent form - 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 Should NOT Join This Trial: (Part1-5) - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria:(Part 1-4) * 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) * Patients with Malignant Melanoma who are refractory or intolerant to standard therapy (Part 4) Inclusion Criteria:(Part 5) * 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 Exclusion criteria: (Part1-5) * 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

Treatments Being Tested

DRUG

CBA-1205 Part 1

CBA-1205: 0.1, 0.3, 1, 3, 10, 20, 30 mg/kg (Intravenous solution)

DRUG

CBA-1205 Part 2

CBA-1205: 20 mg/kg and 30 mg/kg (Intravenous solution)

DRUG

CBA-1205 Part 3

CBA-1205: 30 mg/kg (Intravenous solution)

DRUG

CBA-1205 Part 4

CBA-1205: 20 mg/kg (Intravenous solution)

DRUG

CBA-1205 Part 5

CBA-1205: 10 mg/kg (The initial cohort, Intravenous solution)

Locations (5)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

National Cancer Center Hospital East

Kashiwa, Chiba, Japan

Kanagawa Cancer Center

Yokohama, Kanagawa, Japan

Niigata University Medical and Dental Hospital

Niigata, Niigata, Japan

National Cancer Center Hospital

Chūō, Tokyo, Japan

University of Yamanashi Hospital

Chūō, Yamanashi, Japan

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06636435), the sponsor (Chiome Bioscience INC.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06636435 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06636435?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06636435?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06636435. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06636435. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.