A Study of CBP-1008 in Patients With Advanced Solid Tumor

NCT04740398 | Recruiting Phase 1

• 1 other identifier: CBP-1008-01
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 3

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-1008, a bi-specific ligand conjugated drugs in patients with advanced solid tumors.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (2)

• Incidence and severity of Adverse Events (AEs)

  Assessed by number of patients with AE, Treatment-Emergent Adverse Event (TEAE), serious adverse event (SAE), and discontinuation of study drug due to AE.

  up to 12 months

• To determine the maximum tolerated dose (MTD)

  Dose limiting toxicity (DLT) will be assessed by NCI CTCAE v4.03. MTD is defined as the previous dose level at which 2 out of 3 participants or 2 out of 6 participants experienced DLT.

  Up to 28 days after the first dose of CBP-1008

Secondary Outcomes (12)

• Maximum serum concentration (Cmax) of CBP-1008

  up to 12 months

• Time to maximum serum concentration (Tmax) of CBP-1008

  up to 12 months

• Elimination half-life (T1/2) of CBP-1008

  up to 12 months

• AUC0-t of CBP-1008

  up to 12 months

• Clearance (CL) in the serum of CBP-1008 per unit of time

  up to 12 months

Study Arms (1)

Ia stage - CBP-1008 Dose escalation/ Ib stage - CBP-1008 monotherapy

EXPERIMENTAL

Ia:Patients will receive CBP-1008 IV infusion every 2 weeks until disease progression, intolerability, informed consent withdraw, or other reasons leading to treatment discontinue. Ib:Patients will receive CBP-1008 RP2D IV infusion every two weeks until disease progression, intolerability, informed consent withdraw, or other reasons leading to treatment discontinue.

Drug: CBP-1008

Interventions

CBP-1008 DRUG

CBP-1008 for injection; IV infusion; Infusion for 90 minutes

Ia stage - CBP-1008 Dose escalation/ Ib stage - CBP-1008 monotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ranged 18-70 years (including the boundaries) when signed informed consent form (ICF)
• Has a life expectancy of ≥ 3 months
• Phase Ia: patients with advanced malignant solid tumor who:
• have progressed on or are intolerant to standard therapy, or
• no standard therapy exists
• Phase Ib disease specific Cohorts:
• Cohort 1: Platinum-resistant advanced high-grade serous ovarian cancer, fallopian tube cancer or primary peritoneal cancer.Platinum resistance was defined as progression or recurrence within 6 months after the last dose of platinum. Patients with primary platinum refractory disease are excluded
• Cohort 2: Metastatic triple-negative breast cancer
• Based on most recently analyzed biopsy or other pathological specimens, TNBC was confirmed histologically or cytologically
• Patients have received at least 2 previous systemic chemotherapy regimens for local advanced/metastasis disease. If the patients in the early phase develop into unresectable locally advanced or metastatic disease within 12 months after adjuvant or neoadjuvant chemotherapy, the regimens will be regarded as one of the previous systemic chemotherapy regimens
• Cohort 3: Patients with other advanced solid tumor types who failed from standard therapy or no standard therapy exists or intolerant to the existing treatment, such as: Esophageal squamous cell carcinoma, Non-triple-negative breast cancer, head and neck squamous cell carcinoma, lung squamous cell carcinoma, gastric adenocarcinoma, colon cancer, cervical cancer, endometrial cancer, and so on
• Cohort 4: Other types of ovarian cancer that are resistant to platinum (clear cell carcinoma and/or low-grade serous carcinoma, etc.)
• Has an Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1
• At least 1 measurable tumor lesion according to RECIST v1.1
• Archived tumor tissue samples available or fresh tumor biopsy samples available

You may not qualify if:

• History of allergic reactions to any component of the CBP-1008
• Concurrent malignancy(ies) within 3 years prior to screening other than adequately treated cervical carcinoma-in-situ, skin cancer of basal cell or squamous cell carcinoma, local prostate cancer after radical operation, ductal carcinoma in situ after radical operation
• History of epilepsy
• Active or symptomatic central nervous system metastasis and / or cancerous meningitis with the exception of, asymptomatic or stable brain metastases
• History of congestive heart failure of the New York Heart Association Functional Classification III/IV, unstable angina pectoris, persistent atrial fibrillation, ventricular arrhythmia or conduction block; with risk factors for, or are receiving medications known to prolong QT interval, refractory hypertension (except hypertension patients whose blood pressure is controlled below 140 / 90mmHg by drugs)
• Significant surgical interventions within 21 days prior to the first dose of CBP-1008 or with ongoing post-operative complications
• Radiotherapy administrated within 21 days prior to the first dose of CBP-1008
• Interstitial lung disease, non-infectious pneumonia or a history of poorly controlled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung disease, etc
• Active infections requiring systemic treatment, active viral hepatitis or active tuberculosis
• Pericardial effusion with important clinical significance
• Clinically uncontrolled pleural effusion or ascites requiring drainage within 1 month before administration
• ≥level 2 Peripheral neuropathy, according to NCI CTCAE 4.03 criteria
• For subjects with lung squamous cell carcinoma, there was hemoptysis within 28 days prior to the first dose of CBP-1008 (hemoptysis volume ≥ 2.5ml each time)
• A history of gastrointestinal perforation and / or complete intestinal obstructio within 6 months prior to the first dose of CBP-1008
• There is higher risk of bleeding or fistula caused by the adjacent organs of esophageal lesions (large artery or trachea) invaded by the tumor. Subjects after endotracheal stent implantation

Sponsors & Collaborators

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

Study Sites (3)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100000, China

RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Central Study Contacts

Jiangang Yu

CONTACT

+86 512 85550899; jiangang.yu@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: January 29, 2021
• First Posted: February 5, 2021
• Study Start: March 6, 2019
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)