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

NCT05830097 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: CBP-1019-101
• Study Type: interventional
• Target: 260
• Locations: 2 countries
• Sites: 5

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of Adverse Events (AEs)

  Safety and tolerability: incidence of dose limiting toxicities (DLTs)、treatment emergent adverse events、serious adverse events (SAEs)、electrocardiogram (ECG) and clinical laboratory tests per the National Cancer Institute's Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE 5.0).

  up to 12 months

Secondary Outcomes (1)

• MTD/RP2D of CBP-1019.

  Up to 28 days after the first dose of CBP-1019

Study Arms (1)

Ia stage - CBP-1019 Dose escalation/ Ib、II stage - CBP-1019 monotherapy

EXPERIMENTAL

Ia:Patients will receive CBP-1019 IV infusion every 2 weeks until disease progression, intolerability, informed consent withdraw, or other reasons leading to treatment discontinue. Ib:Patients will receive CBP-1019 RP2D IV infusion every two weeks until disease Patients will receive CBP-1019 RP2D IV infusion every two weeks until disease progression, intolerability, informed consent withdraw, or other reasons leading to treatment discontinue.

Drug: CBP-1019

Interventions

CBP-1019 DRUG

Light yellow to yellow loose lumps or powder；50mg/vial; Infusion for 90 minutes (± 10 minutes), once every 2 weeks.

Also known as: CBP-1019 for injection

Ia stage - CBP-1019 Dose escalation/ Ib、II stage - CBP-1019 monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of informed consent form (ICF) prior to any study-specific procedures.
• Men or women ≥ 18 years old when signed ICF.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS)0-1
• Life expectancy of ≥ 3 months, in the opinion of the Investigator.
• Pathologically documented advanced solid tumor, including but not limited to advanced lung cancer, pancreatic cancer, colorectal cancer, esophageal cancer, and breast cancer, etc.
• 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.
• 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.
• Progress of disease per response evaluation criteria in solid tumors (RECIST) 1.1 after the last anti-tumor treatment (solid tumors).
• 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.
• 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.

You may not qualify if:

• Known prior or suspected hypersensitivity to CBP-1019 or any component in their formulations.
• 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.
• 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.
• 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.
• Washout periods of prior anti-tumor treatments have not been completed.
• Fever \>38.5 °C of unknown cause.
• 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.
• Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA).
• History of clinically significant vascular diseases, including acute arteriovenous embolism, acute thrombotic arteritis, thrombophlebitis, acute pulmonary embolism, acute coronary syndrome .
• \. History of treated active gastrointestinal ulcers, perforations, and/or fistulas within 6 months prior to the first dose of CBP-1019.
• \. History of autoimmune disease, immunodeficiency disease and organ transplantation.

Sponsors & Collaborators

• Coherent Biopharma (Hefei) Co., Ltd.: lead

Study Sites (5)

TOI Clinical Research LLC

Cerritos, California, 90805, United States

RECRUITING

Florida Cancer Specialists & Research Institute

Orlando, Florida, 32827, United States

RECRUITING

Northwell Health Inc.

Manhasset, New York, 11030, United States

RECRUITING

Next Oncology

Fairfax, Virginia, 22031, United States

NOT YET RECRUITING

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Lung Neoplasms; Pancreatic Neoplasms; Esophageal Neoplasms; Colonic Neoplasms

Interventions

Injections

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Gastrointestinal Neoplasms; Head and Neck Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Lin Shen, MD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bin Pan

CONTACT

+86 13917872167; bin.pan@coherentbio.com

Jay X Ma

CONTACT

+1 5408083925; jay.ma@coherentbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: April 26, 2023
• Study Start: March 14, 2023
• Primary Completion: June 30, 2025
• Study Completion: September 30, 2025
• Last Updated: August 26, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (4); CN (1)