Clinical trial NCT06636435: A Phase I, First in Human Study of CBA-1205, Anti-DLK1 Monoclonal Antibody in Patients with Advanced Solid Tumors and Hepatocellular Carcinoma (HCC)
Official title: A Phase I, First in Human Study of CBA-1205, Anti-DLK1 Monoclonal Antibody in Patients with Advanced Solid Tumors and Hepatocellular Carcinoma (HCC)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Hepatocellular Carcinoma (HCC)
Solid Tumors
Keywords: DLK1
First in human
Phase I
Antibody
solid tumor
Hepatocellular Carcinoma
CBA-1205
Lead sponsor: Chiome Bioscience Inc.
Sponsor class: INDUSTRY
First posted: 2024-10-10
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: In this first-in-human, multicenter,non-randomized, open-label, standard 3+3 dose escalation Phase I study encompasses 3parts(Part1-3). 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 three parts in a stepwise manner:

* 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.
* 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.
* 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.
* PK analysis

Eligibility criteria: Inclusion Criteria:

* 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
* Patients with unresectable advanced/recurrent hepatocellular carcinoma refractory or intolerable to standard therapy (Part2, 3: HCC)
* Patients with Child-Pugh A or B (Part2, 3; HCC)

Exclusion criteria:

* 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

Primary outcomes:
measure: Dose limiting toxicity
timeFrame: Part 1, 2, : Within 28 days after the first dose of study treatment
measure: Adverse Event
timeFrame: Maximum12 months
Secondary outcomes:
measure: Pharmacokinetics
timeFrame: Cycle1 Day1, Day2, Day3, Day4, Day8, Day15, Cycle2 Day1, and Cycle2 Day15. Each cycle is 28 days.
measure: Immunogenicity
timeFrame: At Cycle1 Day1, Day15, and Cycle 2 Day1, Day15 (Each cycle is 28 days)
measure: Efficacy
timeFrame: Time Frame: screening period (within 28 days before the start of the study drug), on day 1 of cycles 2, 4, and subsequent even cycles. Each cycle is 28 days
Other outcomes:
measure: Exploration of biomarkers:
timeFrame: Before the treatment (Baseline)
Locations:
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Yokohama
country: Japan
facility: Kanagawa Cancer Center
state: Kanagawa
city: Chuo
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Niigata
country: Japan
facility: Niigata University Medical and Dental Hospital
Study officials:
References: