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Bi-specific Ligand Conjugated Drug
CBP-1019 for Advanced Cancers
Phase 1 & 2
Recruiting
Led By Lin Shen, MD
Research Sponsored by Coherent Biopharma (Hefei) Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
Pathologically documented advanced solid tumor, including but not limited to advanced lung cancer, pancreatic cancer, colorectal cancer, esophageal cancer, and breast cancer, etc
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
Study Summary
This trial will test the safety and effectiveness of a new drug for advanced solid tumors. It will also determine the best dose to use.
Who is the study for?
Adults over 18 with advanced solid tumors, including lung, pancreatic, colorectal, esophageal, and breast cancer. They must have tried standard treatments or be unsuitable for them. Participants need a life expectancy of at least 3 months and good performance status (able to carry out daily activities). Tumor tissue is required for testing specific receptors. Women who can bear children and men with partners who can must use approved contraception.Check my eligibility
What is being tested?
The trial tests CBP-1019's safety and effectiveness in treating various advanced cancers. It aims to find the best dose for phase II trials. Patients will receive CBP-1019 to see how well it works against their cancer and what side effects it may cause.See study design
What are the potential side effects?
Potential side effects of CBP-1019 are not specified but could include typical reactions seen with cancer therapies such as fatigue, nausea, organ inflammation or immune system reactions given its bi-specific ligand drug nature.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
Select...
I have an advanced solid tumor, such as lung, pancreatic, or breast cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence and severity of Adverse Events (AEs)
Secondary outcome measures
MTD/RP2D of CBP-1019.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Ia stage - CBP-1019 Dose escalation/ Ib、II stage - CBP-1019 monotherapyExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
Coherent Biopharma (Hefei) Co., Ltd.Lead Sponsor
Lin Shen, MDPrincipal InvestigatorPeking University Cancer Hospital & Institute
25 Previous Clinical Trials
9,022 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a fever over 38.5°C without knowing why.I have an active Hepatitis B infection with specific virus levels.My cancer has grown after my last treatment.My organs and bone marrow are working well.I can provide a tumor sample for specific testing if I choose a low dose treatment.I haven't had any cancer other than early-stage skin or superficial bladder cancer in the last 5 years.All my side effects from cancer treatment are mild, except for hair loss and tiredness.I have tried or am considered unable to benefit from standard cancer treatments.I have at least one cancer lesion that can be measured.You have not finished waiting for a certain amount of time after stopping previous cancer treatments.I frequently need fluid drained from my chest, heart area, or abdomen.I am 18 years old or older.I am fully active or can carry out light work.My heart condition severely limits my physical activity.I have an advanced solid tumor, such as lung, pancreatic, or breast cancer.I had treatment for stomach or intestinal ulcers, perforations, or fistulas in the last 6 months.My cancer has spread to my brain or spinal cord.You have a history of autoimmune disease, weak immune system, or organ transplant.I am using or willing to use birth control during and after the study.I have a history of serious blood vessel problems.You have had an allergic reaction to CBP-1019 or any of its ingredients before.
Research Study Groups:
This trial has the following groups:- Group 1: Ia stage - CBP-1019 Dose escalation/ Ib、II stage - CBP-1019 monotherapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are additional participants being enlisted for this experiment?
"Unfortunately, clinicaltrials.gov reports that this study has concluded its recruitment of participants and is not currently accepting new patients. This trial was first created on March 14th 2023 and last modified on April 13rd 2023; however, there are still 5492 other trials actively recruiting people at the moment."
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