RECRUITING

A Study of Bi-Ligand-Drug Conjugate CBP-1019 in Patients With Advanced Solid Tumors

Conditions

Cancer, Breast Cancer, Lung Cancer of Pancreas Cancer of Esophagus Cancer Colorectal

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

An Open-Label, Non-randomized, Multinational, Multi-center Phase I/Ⅱ Study Evaluating the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Bi-Ligand-Drug Conjugate CBP-1019 in Patients With Advanced Solid Tumors

Quick Facts

Study Start:2023-03-14

Study Completion:2025-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05830097

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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). 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.

Inclusion Criteria

Exclusion 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.

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).
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.

Contacts and Locations

Study Contact

Bin Pan

CONTACT

+86 13917872167

bin.pan@coherentbio.com

Jay X Ma

CONTACT

+1 5408083925

jay.ma@coherentbio.com

Principal Investigator

Lin Shen, MD

PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Study Locations (Sites)

TOI Clinical Research LLC

Cerritos, California, 90805

United States

Florida Cancer Specialists & Research Institute

Orlando, Florida, 32827

United States

Northwell Health Inc.

Manhasset, New York, 11030

United States

Next Oncology

Fairfax, Virginia, 22031

United States

Collaborators and Investigators

Sponsor: Coherent Biopharma (Hefei) Co., Ltd.

Lin Shen, MD, PRINCIPAL_INVESTIGATOR, Peking University Cancer Hospital & Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-14

Study Completion Date2025-09-30

Study Record Updates

Study Start Date2023-03-14

Study Completion Date2025-09-30

Terms related to this study

Additional Relevant MeSH Terms

Cancer, Breast
Cancer, Lung
Cancer of Pancreas
Cancer of Esophagus
Cancer Colorectal