Evaluating a new drug for patients with advanced solid tumors
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
This study is testing a new drug called CBP-1019 to see if it can help people with advanced solid tumors who haven't had success with other treatments.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 260 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Coherent Biopharma (Hefei) Co., Ltd. Industry-sponsored |
| Locations | 5 sites (Cerritos, California and 4 other locations) |
| Trial ID | NCT05830097 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the safety and efficacy of CBP-1019, a bi-specific ligand drug conjugate, in patients with advanced solid tumors. The study consists of two phases: a dose-escalation phase to determine the maximum tolerated dose and a subsequent phase to evaluate the drug's effectiveness in specific tumor types. Patients who have not responded to standard treatments or have no available standard therapies will be enrolled. The trial will monitor various outcomes, including objective response rates and progression-free survival, while also examining the relationship between tumor response and receptor expression.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with pathologically documented advanced solid tumors who have previously received standard therapies.
Not a fit: Patients with early-stage tumors or those who have not yet undergone standard treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have limited treatment choices.
How similar studies have performed: While this approach is novel, similar studies targeting advanced solid tumors with bi-specific ligands have shown promise in early phases.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cerritos, California and 4 other locations
- TOI Clinical Research LLC — Cerritos, California, United States (Recruiting)
- Florida Cancer Specialists & Research Institute — Orlando, Florida, United States (Recruiting)
- Northwell Health Inc. — Manhasset, New York, United States (Recruiting)
- Next Oncology — Fairfax, Virginia, United States (Not_yet_recruiting)
- Beijing Cancer Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Principal investigator: Lin Shen, MD — Peking University Cancer Hospital & Institute
- Study coordinator: Bin Pan
- Email: bin.pan@coherentbio.com
- Phone: +86 13917872167
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.