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

ConditionsSolid Tumors Hepatocellular Carcinoma (HCC)Malignant Melanoma Pediatric Cancer

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age2+

SponsorChiome Bioscience Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

CBA-1205 Part 1
Drug
CBA-1205: 0.1, 0.3, 1, 3, 10, 20, 30 mg/kg (Intravenous solution)
CBA-1205 Part 2
Drug
CBA-1205: 20 mg/kg and 30 mg/kg (Intravenous solution)
CBA-1205 Part 3
Drug
CBA-1205: 30 mg/kg (Intravenous solution)
CBA-1205 Part 4
Drug
CBA-1205: 20 mg/kg (Intravenous solution)
CBA-1205 Part 5
Drug
CBA-1205: 10 mg/kg (The initial cohort, Intravenous solution)

Treatment groups

66 Participants

are divided into 5 treatment groups

Group A: CBA-1205: Part 1Experimental treatment 1 intervention

Group B: CBA-1205: Part 2Experimental treatment 1 intervention

Group C: CBA-1205: Part 3Experimental treatment 1 intervention

Group D: CBA-1205 : Part 4Experimental treatment 1 intervention

Group E: CBA-1205: Part 5Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

Dose limiting toxicity

DLTs are assessed according to CTCAE v.5.0 during the first cycle (28 days).

Time frame

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

Time frame

Adverse event : Maximum 12 months

Secondary outcomes

Serum CBA-1205 concentration

Blood samples are collected to assess the serum concentration of CBA-1205.

Time frame

From Day 1 to Day 43 (or until Discontiuation of treatment)

Immunogenicity

Blood samples are collected to assess the serum anti-CBA-1205 antibody.

Time frame

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

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

Other outcomes

Exploration of biomarkers:

Exploration of biomarkers: Delta-like 1 homolog (DLK1)-related marker

Time frame

Baseline through disease progression assessed (Maximum 12 months.)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chiome Bioscience Inc.

Lead sponsor

Source ClinicalTrials.gov

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