Advanced Solid TumorPhase 1NCT04740398
A Study of CBP-1008 in Patients With Advanced Solid Tumor
A Phase 1 study testing CBP-1008 in people with Advanced Solid Tumor, run by Coherent Biopharma (Suzhou) Co., Ltd. at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- CBP-1008
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 3 sitesChina
- Study dates
- 6 Mar 2019to Sep 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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
- FOLR1 and/or TRPV6 receptor expression tested positive by the central laboratory
- The time window from the last administration of previous anti-tumor therapy to the first administration of CBP-1008 in this study was at least 28 days. No other trial drugs or experimental instruments was used or other clinical trials were conducted within 28 days before the start of trial drugs
- According to the NCI-CTCAE 4.03 version, the acute toxicity of any previous treatment, surgery or radiotherapy must have been alleviated to grade 0 or 1
- Adequate hematologic status (without receiving blood transfusion and growth factor support within 2 weeks before enrollment), defined as:
- Absolute neutrophil count (ANC) ≥ 1.5× 109/L
- Platelet count ≥ 90 × 109/L
- Hemoglobin (Hb) ≥ 95 g/L
- Adequate hepatic function, defined as:
- Serum total bilirubin (TBIL) ≤ 1.5× ULN, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5× ULN if no demonstrable liver metastases (ALT and AST ≤ 3.0× ULN in the presence of liver metastases)
- Adequate renal function, defined as:
- Serum creatinine < upper limit of laboratory normal reference range, or creatinine clearance ≥50 mL/min/1.73㎡ (The calculation formula is shown in Appendix 11)
- Coagulation: International Normalized Ratio (INR) ≤ 1.5× ULN and activated partial thromboplastin time (APTT) ≤ 1.5× ULN (except patients who are receiving therapeutic anticoagulation, whose INR should be within the therapeutic range)
- Appropriate serum calcium concentration: Refer to serum albumin-corrected calcium concentration ≥ 1 × lower limit of normal (ULN) and ≤ 2.9 mmol/L (11.5 mg/dL) if the subjects had hypocalcemia and hypoproteinemia
- Adequate cardiac function, defined as:
- Left ventricular eject fraction (LVEF) ≥ 50% or lower limit of normal reference range in hospital
- QTc-F≤ 450 ms
Who cannot join
- 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
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- 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
- Foods or drugs known as potent or moderate CYP3A inhibitors or potent CYP3A inducers which has been used 10 days before the first dose or is expected to use
- Female subject who are pregnant or breastfeeding or considering pregnancy
- Any medical situation assessed by the researcher may increase the patient's safety risk, limit study compliance or interfere with study evaluation
- Alcoholism within 3 months prior to the first dose of CBP-1008
- Known drug abuse within 6 months before signing ICF
- Human immunodeficiency virus infection (HIV-1/2 antibody positive), active hepatitis B virus (HBV) infection，hepatitis C virus (HCV) infection (HCV antibody positive) or syphilis infection. Active hepatitis B was defined as HBV DNA ≥ upper limit of laboratory normal reference range
- Other situations considered unsuitable for inclusion by the researcher
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100000
Lin Shen, shenlin@bjmu.edu.cn
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100000
Lingying Wu, wulingying@csco.org.cn
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200000
Xichun Hu, huxichun2017@163.com
About this study
Official title: A Phase Ia/Ib, Open-Label, Multi-center, First in Human and Expansion Study to Assess the Safety, Tolerance, and Pharmacokinetics of the Novel Antitumor Agent CBP-1008 in Patients With Advanced Solid Tumors
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.
Read the detailed description
This phase Ia/Ib, open-label, multicenter study has two stages. The Ia stage is a dose-escalation study that will focus on safety, tolerability, pharmacokinetics, MTD and RP2D. Patients with advanced solid tumor who failed from previous standard treatment or without standard therapy exists will be enrolled in the phase Ia study. DLT observation period is 28 days.
Patients in phase Ib part will be recruited into certain tumor cohorts and receive RP2D CBP-1008 iv infusion every two weeks. Primary efficacy of ORR, DCR, PFS, etc., will be evaluated. The correlation between tumor response and the receptors will be explored. Safety information will be collected in phase Ib stage.
- Conditions
- Advanced Solid Tumor
- Being tested
- CBP-1008
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBP-1008Drug
CBP-1008 for injection; IV infusion; Infusion for 90 minutes
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: CBP-1008 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 28 days after the first dose of CBP-1008
Secondary outcomes (12)
Maximum serum concentration (Cmax) of CBP-1008
Maximum serum concentration (Cmax) of CBP-1008 will be investigated.
Measured: up to 12 months
Time to maximum serum concentration (Tmax) of CBP-1008
Tmax of CBP-1008 will be investigated.
Measured: up to 12 months
Elimination half-life (T1/2) of CBP-1008
T1/2 of CBP-1008 will be investigated.
Measured: up to 12 months
AUC0-t of CBP-1008
AUC0-t is defined as area under the serum concentration-time curve from time 0 to the time of the last measurable concentration.
Measured: up to 12 months
Clearance (CL) in the serum of CBP-1008 per unit of time
CL in the serum of CBP-1008 per unit of time will be investigated.
Measured: up to 12 months
6. The percentage of participants with anti-drug antibody (ADA) positive after dosing CBP-1008
Incidence and titer of ADA against CBP-1008 will be evaluated.
Measured: up to 12 months
Recommended Phase II Dose (RP2D)
The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) based on safety, tolerability, efficacy, PK data collected during the dose escalation study of CBP-1008.
Measured: up to 12 months
Objective Response Rate (ORR)
ORR was defined as the percentage of participants, who had a CR or PR. The percentage of participants who experienced a confirmed CR or PR is evaluated by investigator according to RECIST 1.1.
Measured: up to 12 months
Duration of Response (DOR)
The DOR for a responder is defined as the time from the participant's initial objective response to the first date of either disease progression or death, whichever occurs first. The DOR is evaluated by investigator according to RECIST 1.1.
Measured: up to 12 months
Clinical benefit rate (CBR)
CBR was defined as the percentage of participants, who had a CR, PR or SD. The percentage of participants who experienced a confirmed CR, PR or SD is evaluated by investigator according to RECIST 1.1.
Measured: up to 12 months
Progression-free survival rate (PFS)
The PFS is defined as the time from the participant's first dose of CBP-1008 to the first date of either disease progression or death, which will be evaluated by investigator according to RECIST 1.1.
Measured: up to 12 months
Overall survival rate (OS)
12 months OS will be evaluated by investigator according to RECIST 1.1.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start6 Mar 2019
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 143 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Coherent Biopharma (Suzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04740398
- Sponsor's protocol ID
- CBP-1008-01
- Status last verified
- Aug 2024
- First submitted
- 29 Jan 2021
- Last updated
- 28 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ia/Ib, Open-Label, Multi-center, First in Human and Expansion Study to Assess the Safety, Tolerance, and Pharmacokinetics of the Novel Antitumor Agent CBP-1008 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04740398
- Acronym / sponsor ID
- CBP-1008-01
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 143 participants (estimated)
- Lead sponsor
- Coherent Biopharma (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Mar 2019 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 5 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This phase Ia/Ib, open-label, multicenter study has two stages. The Ia stage is a dose-escalation study that will focus on safety, tolerability, pharmacokinetics, MTD and RP2D. Patients with advanced solid tumor who failed from previous standard treatment or without standard therapy exists will be enrolled in the phase Ia study. DLT observation period is 28 days.
Patients in phase Ib part will be recruited into certain tumor cohorts and receive RP2D CBP-1008 iv infusion every two weeks. Primary efficacy of ORR, DCR, PFS, etc., will be evaluated. The correlation between tumor response and the receptors will be explored. Safety information will be collected in phase Ib stage.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ia stage - CBP-1008 Dose escalation/ Ib stage - CBP-1008 monotherapy | Experimental | Drug: CBP-1008Ia: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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (31 listed)
- 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
Key exclusion criteria (22 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBP-1008CBP-1008 for injection; IV infusion; Infusion for 90 minutes | Drug | Ia stage - CBP-1008 Dose escalation/ Ib stage - CBP-1008 monotherapy |
Primary outcome
Incidence and severity of Adverse Events (AEs)
Time frame: up to 12 months
Assessed by number of patients with AE, Treatment-Emergent Adverse Event (TEAE), serious adverse event (SAE), and discontinuation of study drug due to AE.
To determine the maximum tolerated dose (MTD)
Time frame: Up to 28 days after the first dose of CBP-1008
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.
12 secondary outcomes
Maximum serum concentration (Cmax) of CBP-1008
Time frame: up to 12 months
Time to maximum serum concentration (Tmax) of CBP-1008
Time frame: up to 12 months
Elimination half-life (T1/2) of CBP-1008
Time frame: up to 12 months
AUC0-t of CBP-1008
Time frame: up to 12 months
Clearance (CL) in the serum of CBP-1008 per unit of time
Time frame: up to 12 months
6. The percentage of participants with anti-drug antibody (ADA) positive after dosing CBP-1008
Time frame: up to 12 months
Recommended Phase II Dose (RP2D)
Time frame: up to 12 months
Objective Response Rate (ORR)
Time frame: up to 12 months
Duration of Response (DOR)
Time frame: up to 12 months
Clinical benefit rate (CBR)
Time frame: up to 12 months
Progression-free survival rate (PFS)
Time frame: up to 12 months
Overall survival rate (OS)
Time frame: up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CBP-1008 in people with Advanced Solid Tumor, run by Coherent Biopharma (Suzhou) Co., Ltd. at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 31 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiangang Yu (+86 512 85550899 ext. 8010, jiangang.yu@coherentbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of Adverse Events (AEs) (time frame: up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.