Trial Title:
A Study of Bi-Ligand-Drug Conjugate CBP-1019 in Patients With Advanced Solid Tumors
NCT ID:
NCT05830097
Condition:
Cancer, Breast
Cancer, Lung
Cancer of Pancreas
Cancer of Esophagus
Cancer Colorectal
Conditions: Official terms:
Breast Neoplasms
Pancreatic Neoplasms
Lung Neoplasms
Esophageal Neoplasms
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
CBP-1019
Description:
Light yellow to yellow loose lumps or powder；50mg/vial; Infusion for 90 minutes (± 10
minutes), once every 2 weeks.
Arm group label:
Ia stage - CBP-1019 Dose escalation/ Ib、II stage - CBP-1019 monotherapy
Other name:
CBP-1019 for injection
Summary:
The primary objective of this phase I study is to evaluate the safety and potential
efficacy and to determine the recommended phase 2 dose (RP2D) of CBP-1019, a bi-specific
ligand conjugated drugs in patients with advanced solid tumors.
Detailed description:
This phase Ia and Ib/II, open-label, multicenter study has two stages. The Ia stage is a
dose-escalation study that will focus on safety, tolerability, pharmacokinetics, maximum
tolerated dose (MTD) and phase 2 dose (RP2D). Patients with advanced solid tumor who
failed from previous standard treatment or without standard therapy exists will be
enrolled in the phase Ia study. Dose-limiting toxicity (DLT) observation period is 28
days.
Patients in phase Ib/II part will be recruited into certain tumor cohorts and receive
RP2D CBP-1019 iv infusion every two weeks. Primary efficacy of objective response rate
(ORR), disease control rate (DCR), progression free survival (PFS), etc., will be
evaluated. The correlation between tumor response and the receptors will be explored.
Safety information will be collected in phase Ib/II stage.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Provision of informed consent form (ICF) prior to any study-specific procedures.
2. Men or women ≥ 18 years old when signed ICF.
3. Eastern Cooperative Oncology Group (ECOG) performance status (PS)0-1
4. Life expectancy of ≥ 3 months, in the opinion of the Investigator.
5. Pathologically documented advanced solid tumor, including but not limited to
advanced lung cancer, pancreatic cancer, colorectal cancer, esophageal cancer, and
breast cancer, etc.
6. The tumor tissue should be provided for folate receptor α (FRα) and transient
receptor potential cation channel subfamily V member 6 (TRPV6) immunohistochemistry
(IHC) testing, optional for low dose level (≤ 2.0 mg/kg) of phaseⅠa. Tumor FRα and
TRPV6 expression as determined by an IHC assay performed by a central laboratory on
previously obtained archival tumor tissue or tissue obtained from a biopsy at
screening.
7. Subjects must have received prior standard therapy appropriate for their tumor type
and stage of disease, or in the opinion of the investigator, would be unlikely to
tolerate or derive clinically meaningful benefit from appropriate standard of care
therapy, or absence of standard therapy.
8. Progress of disease per response evaluation criteria in solid tumors (RECIST) 1.1
after the last anti-tumor treatment (solid tumors).
9. At least one measurable soft tissue lesion per RECIST 1.1, lesions received prior
radiotherapy can be regarded as measurable only when occurring conclusive
progression after radiotherapy, optional for low dose level (≤ 2.0 mg/kg) of Phase
Ⅰa.
10. Adequate bone marrow and organ function, defined as:
- Absolute neutrophil count (ANC) ≥ 1.5 × 109/L.
- Platelet count ≥ 100 × 109/L.
- Hemoglobin (Hb) ≥ 90 g/L.
- Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN), or ≤ 2 × ULN for
subjects with liver metastases.
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 ×
ULN, or ≤ 2 × ULN for subjects with liver metastases.
- Creatinine clearance (CCr) ≥ 60 mL/min as calculated using Cockcroft-Gault
formula
11. Women of child-bearing potential (WOCBP) or male subjects whose spouse is WOCBP need
to adopt a medically approved contraceptive measure (such as intra-uterine device
(IUD), contraceptive pill, or condom) throughout the study and for at least 3 months
in males and 6 months in females after the last dose of CBP-1019.
Exclusion Criteria:
1. Known prior or suspected hypersensitivity to CBP-1019 or any component in their
formulations.
2. Concurrent malignancy within 5 years prior to the first dose of CBP-1019, other than
clinically considered cured early malignant tumors (carcinoma in situ or stage I
tumor) such as basal cell carcinoma, localized squamous cell cancer of the skin,
Superficial bladder cancer, etc.
3. Central nervous system (CNS) metastasis and/or carcinomatous meningitis. Treated CNS
metastasis may be enrolled only if it is stable for at least 1 month, no evidence of
new or expanded lesions exist, and steroid treatment has been discontinued at least
3 days before the first dose of CBP-1019.
4. Poorly controlled pleural effusion, pericardial effusion, or ascites, or those need
repeated drainage, such as drainage once a month or more frequently, or within 2
weeks before the dose of CBP-1019.
5. Washout periods of prior anti-tumor treatments have not been completed.
6. Any toxicities of prior anti-cancer therapy not resolved to Grade 1 per NCI CTCAE
5.0 or inclusion criteria, other than alopecia and fatigue.
7. Fever >38.5 °C of unknown cause.
8. Positive Hepatitis B Surface Antigen (HbsAg) and Hepatitis B virus (HBV) DNA ≥ 500
IU/mL or 2500 copies or lower limits of normal (LLN) of positive.
9. Class III or IV congestive heart failure, as defined by the New York Heart
Association (NYHA).
10 History of clinically significant vascular diseases, including acute arteriovenous
embolism, acute thrombotic arteritis, thrombophlebitis, acute pulmonary embolism, acute
coronary syndrome .
11. History of treated active gastrointestinal ulcers, perforations, and/or fistulas
within 6 months prior to the first dose of CBP-1019.
12. History of autoimmune disease, immunodeficiency disease and organ transplantation.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
TOI Clinical Research LLC
Address:
City:
Cerritos
Zip:
90805
Country:
United States
Status:
Recruiting
Facility:
Name:
Florida Cancer Specialists & Research Institute
Address:
City:
Orlando
Zip:
32827
Country:
United States
Status:
Recruiting
Facility:
Name:
Northwell Health Inc.
Address:
City:
Manhasset
Zip:
11030
Country:
United States
Status:
Recruiting
Facility:
Name:
Next Oncology
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Start date:
March 14, 2023
Completion date:
September 30, 2025
Lead sponsor:
Agency:
Coherent Biopharma (Hefei) Co., Ltd.
Agency class:
Industry
Source:
Coherent Biopharma (Hefei) Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05830097
