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

Phase 1

Recruiting

• Conditions: Cancer, Breast; Cancer, Lung; Cancer of Pancreas; Cancer of Esophagus; Cancer Colorectal

• Registration Number: NCT05830097
• Lead Sponsor: Coherent Biopharma (Hefei) Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-3-29
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Provision of informed consent form (ICF) prior to any study-specific procedures.<br><br> 2. Men or women = 18 years old when signed ICF.<br><br> 3. Eastern Cooperative Oncology Group (ECOG) performance status (PS)0-1<br><br> 4. Life expectancy of = 3 months, in the opinion of the Investigator.<br><br> 5. Pathologically documented advanced solid tumor, including but not limited to<br> advanced lung cancer, pancreatic cancer, colorectal cancer, esophageal cancer, and<br> breast cancer, etc.<br><br> 6. The tumor tissue should be provided for folate receptor a (FRa) and transient<br> receptor potential cation channel subfamily V member 6 (TRPV6) immunohistochemistry<br> (IHC) testing, optional for low dose level (= 2.0 mg/kg) of phase?a. Tumor FRa and<br> TRPV6 expression as determined by an IHC assay performed by a central laboratory on<br> previously obtained archival tumor tissue or tissue obtained from a biopsy at<br> screening.<br><br> 7. Subjects must have received prior standard therapy appropriate for their tumor type<br> and stage of disease, or in the opinion of the investigator, would be unlikely to<br> tolerate or derive clinically meaningful benefit from appropriate standard of care<br> therapy, or absence of standard therapy.<br><br> 8. Progress of disease per response evaluation criteria in solid tumors (RECIST) 1.1<br> after the last anti-tumor treatment (solid tumors).<br><br> 9. At least one measurable soft tissue lesion per RECIST 1.1, lesions received prior<br> radiotherapy can be regarded as measurable only when occurring conclusive<br> progression after radiotherapy, optional for low dose level (= 2.0 mg/kg) of Phase<br> ?a.<br><br> 10. Adequate bone marrow and organ function, defined as:<br><br> - Absolute neutrophil count (ANC) = 1.5 × 109/L.<br><br> - Platelet count = 100 × 109/L.<br><br> - Hemoglobin (Hb) = 90 g/L.<br><br> - Total bilirubin (TBIL) = 1.5 × upper limit of normal (ULN), or = 2 × ULN for<br> subjects with liver metastases.<br><br> - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 1.5 ×<br> ULN, or = 2 × ULN for subjects with liver metastases.<br><br> - Creatinine clearance (CCr) = 60 mL/min as calculated using Cockcroft-Gault<br> formula<br><br> 11. Women of child-bearing potential (WOCBP) or male subjects whose spouse is WOCBP need<br> to adopt a medically approved contraceptive measure (such as intra-uterine device<br> (IUD), contraceptive pill, or condom) throughout the study and for at least 3 months<br> in males and 6 months in females after the last dose of CBP-1019.<br><br>Exclusion Criteria:<br><br> 1. Known prior or suspected hypersensitivity to CBP-1019 or any component in their<br> formulations.<br><br> 2. Concurrent malignancy within 5 years prior to the first dose of CBP-1019, other than<br> clinically considered cured early malignant tumors (carcinoma in situ or stage I<br> tumor) such as basal cell carcinoma, localized squamous cell cancer of the skin,<br> Superficial bladder cancer, etc.<br><br> 3. Central nervous system (CNS) metastasis and/or carcinomatous meningitis. Treated CNS<br> metastasis may be enrolled only if it is stable for at least 1 month, no evidence of<br> new or expanded lesions exist, and steroid treatment has been discontinued at least<br> 3 days before the first dose of CBP-1019.<br><br> 4. Poorly controlled pleural effusion, pericardial effusion, or ascites, or those need<br> repeated drainage, such as drainage once a month or more frequently, or within 2<br> weeks before the dose of CBP-1019.<br><br> 5. Washout periods of prior anti-tumor treatments have not been completed.<br><br> 6. Any toxicities of prior anti-cancer therapy not resolved to Grade 1 per NCI CTCAE<br> 5.0 or inclusion criteria, other than alopecia and fatigue.<br><br> 7. Fever >38.5 °C of unknown cause.<br><br> 8. Positive Hepatitis B Surface Antigen (HbsAg) and Hepatitis B virus (HBV) DNA = 500<br> IU/mL or 2500 copies or lower limits of normal (LLN) of positive.<br><br> 9. Class III or IV congestive heart failure, as defined by the New York Heart<br> Association (NYHA).<br><br>10 History of clinically significant vascular diseases, including acute arteriovenous<br>embolism, acute thrombotic arteritis, thrombophlebitis, acute pulmonary embolism, acute<br>coronary syndrome .<br><br> 11. History of treated active gastrointestinal ulcers, perforations, and/or fistulas<br> within 6 months prior to the first dose of CBP-1019.<br><br> 12. History of autoimmune disease, immunodeficiency disease and organ transplantation.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence and severity of Adverse Events (AEs)

Secondary Outcome Measures

Name	Time	Method
MTD/RP2D of CBP-1019.