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Monoclonal Antibodies
CPI-006 Combinations for Advanced Cancer
Phase 1
Waitlist Available
Research Sponsored by Corvus Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of treatment to end of treatment, up to 36 months
Awards & highlights
Study Summary
This trial is testing a new cancer drug, CPI-006, alone and in combination with other drugs, to see if it is safe and effective in treating advanced cancer.
Who is the study for?
This trial is for adults with certain advanced cancers who have had limited prior treatments, can perform daily activities without significant assistance (ECOG 0-1), and have at least one measurable tumor. It's not for those with untreated brain metastases, severe reactions to monoclonal antibodies, recent investigational drug use, or specific immunotherapy-related side effects.Check my eligibility
What is being tested?
The study tests CPI-006 alone and in combination with ciforadenant or pembrolizumab in patients with select advanced cancers. It's a Phase 1/1b trial aiming to find the right dose and see how safe and effective these combinations are against various cancer types.See study design
What are the potential side effects?
Potential side effects may include typical reactions related to immune therapies such as inflammation of organs, infusion-related symptoms, allergic reactions similar to past monoclonal antibody treatments, fatigue, skin issues, and possibly pneumonitis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from start of treatment to end of treatment, up to 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of treatment to end of treatment, up to 36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Identify the MDL(maximum dose level) of single agent CPI-006
Incidence of dose-limiting toxicities (DLTs) of CPI-006 as a single agent and in combination with ciforadenant and with pembrolizumab.
Incidence of treatment-emergent adverse events as assessed by NCI CTCAE v.4.03, of CPI-006 as single agent and in combination with ciforadenant and with pembrolizumab.
Secondary outcome measures
Area under the curve (AUC) of CPI-006
Serum
Objective response rate per RECIST v.1.1 criteria of CPI-006 as single agent and in combination with ciforadenant and with pembrolizumab.
Trial Design
6Treatment groups
Experimental Treatment
Group I: Cohort1bExperimental Treatment1 Intervention
CPI-006 + ciforadenant
Group II: Cohort 2cExperimental Treatment1 Intervention
CPI-006 + pembrolizumab
Group III: Cohort 2bExperimental Treatment1 Intervention
CPI-006 + ciforadenant
Group IV: Cohort 2aExperimental Treatment1 Intervention
CPI-006
Group V: Cohort 1cExperimental Treatment1 Intervention
CPI-006 + pembrolizumab
Group VI: Cohort 1aExperimental Treatment1 Intervention
CPI-006
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CPI-006 + pembrolizumab
2018
Completed Phase 1
~120
CPI-006
2018
Completed Phase 1
~150
CPI-006 + ciforadenant
2018
Completed Phase 1
~120
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Non-Hodgkin's Lymphoma (NHL) treatments often target specific molecules or pathways involved in cancer cell survival and proliferation. CD73 inhibitors like CPI-006 block the CD73 enzyme, reducing adenosine production and enhancing anti-tumor immune responses.
Other common treatments include monoclonal antibodies such as rituximab, which targets the CD20 protein on B-cells, leading to their destruction. Chemotherapy agents like cyclophosphamide and doxorubicin disrupt DNA replication in rapidly dividing cells.
Immune checkpoint inhibitors, such as pembrolizumab, block PD-1/PD-L1 interactions, reactivating T-cells to attack cancer cells. These mechanisms are crucial as they offer targeted approaches to eliminate cancer cells while sparing normal cells, improving treatment efficacy and reducing side effects for NHL patients.
Find a Location
Who is running the clinical trial?
Corvus Pharmaceuticals, Inc.Lead Sponsor
7 Previous Clinical Trials
824 Total Patients Enrolled
S Mahabhashyam, MDStudy ChairCorvus Pharmaceuticals
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are able to perform daily activities without assistance or with minimal help.If you're in the first group, you've tried 1 to 5 treatments before. If you're in the second group, you've had your disease get worse, didn't respond to, or couldn't tolerate 1 to 3 treatments before.You have at least one detectable tumor that can be measured using specific criteria.You have untreated or worsening brain tumors that are causing symptoms.You have had a serious allergic reaction to monoclonal antibodies in the past.You should be in good enough health to perform daily activities without any problems.You have had a lung inflammation that wasn't caused by an infection and needed treatment with steroids, or you currently have lung inflammation.You have taken certain medications for cancer treatment in the past, and any side effects from those medications need to be completely resolved before you can join the study.You have a type of cancer that cannot be cured.For the first part, you have tried at least one but not more than five treatments for your advanced or recurring disease. For the second part, you have either not responded well to or could not tolerate one to three previous treatments.You are willing to have a sample of your tumor taken for testing.You have a type of cancer that cannot be cured, such as lung, kidney, breast, colorectal, bladder, cervical, uterine, or prostate cancer.You have at least one noticeable and measurable tumor according to specific guidelines.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort1b
- Group 2: Cohort 1c
- Group 3: Cohort 2a
- Group 4: Cohort 2b
- Group 5: Cohort 2c
- Group 6: Cohort 1a
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.
Non-Hodgkin's Lymphoma Patient Testimony for trial: Trial Name: NCT03454451 — Phase 1
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