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Unknown

CS5001 for Advanced Cancers

Phase 1
Recruiting
Research Sponsored by CStone Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
For solid tumor patients of dose escalation, they must have pathologically confirmed, unresectable advanced solid tumor with disease progression on or after at least 1 line of prior systemic therapy.
Female subjects of childbearing potential must have a negative serum pregnancy test.
Must not have
Women who are pregnant or breastfeeding.
Significant cardiovascular disease within 6 months prior to the first dose of the study drug.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up about 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug called CS5001 to see if it is safe and effective for patients with advanced blood-related and solid cancers. The drug aims to attack and stop the growth of cancer cells.

Who is the study for?
This trial is for adults with advanced solid tumors or lymphomas that have worsened after treatment. They must have at least one measurable tumor, a life expectancy over 3 months, good performance status and organ function, agree to provide tissue samples and use contraception. Not eligible if they've had certain other cancers, active infections or HIV/AIDS, recent heart issues or treatments, are pregnant/breastfeeding, or have untreated brain metastases.
What is being tested?
The study tests CS5001 in patients with advanced tumors/lymphomas who've seen their disease progress after prior therapies. It's the first time this drug is being tried in humans (FIH), aiming to assess its safety and early effectiveness.
What are the potential side effects?
As CS5001 is experimental and this trial marks its first use in humans, specific side effects are unknown but may include typical reactions related to cancer drugs such as fatigue, nausea, risk of infection and potential impact on blood counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My solid tumor is advanced, cannot be surgically removed, and has worsened after treatment.
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I am of childbearing age and have a negative pregnancy test.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I have Hodgkin or B-cell non-Hodgkin lymphoma that has worsened after 2 treatments.
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I have MCL, DLBCL, or TNBC and have had at least two treatments, including one for MCL.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant or breastfeeding.
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I have not had serious heart problems in the last 6 months.
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I have an immune system disorder or need steroids for another health issue.
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I have brain tumors or lymphoma that need treatment.
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I haven't had cancer treatment or major surgery in the last 3 weeks.
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I have swelling, fluid around my heart or in my abdomen needing treatment, or a history of blood vessel issues.
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I haven't had any infections needing treatment in the last 2 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~about 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and about 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximum Tolerated Dose (MTD) of CS5001 if any (for dose escalation part)
Recommended Phase 2 Dose(RP2D) of CS5001 (for dose escalation part)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Dose expansionExperimental Treatment1 Intervention
Group II: Dose escalationExperimental Treatment1 Intervention

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
The most common treatments for lymphoma include targeted therapies, immunotherapies, and chemotherapy. Targeted therapies, such as Bruton tyrosine kinase (BTK) inhibitors and BCL2 inhibitors, work by specifically targeting and inhibiting pathways crucial for cancer cell survival and proliferation. Immunotherapies, including monoclonal antibodies like rituximab, enhance the immune system's ability to recognize and destroy cancer cells. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cells, including cancer cells. Understanding these mechanisms is crucial for lymphoma patients as it helps in selecting the most effective treatment based on the specific characteristics of their disease, potentially improving outcomes and minimizing side effects.
[Staging and Treatment Response Evaluation in Malignant Lymphomas - Czech Lymphoma Study Group Recommendations According to Criteria Revised in 2014 (Lugano Classification)].[Multiple myeloma].

Find a Location

Who is running the clinical trial?

CStone PharmaceuticalsLead Sponsor
26 Previous Clinical Trials
3,685 Total Patients Enrolled
4 Trials studying Lymphoma
419 Patients Enrolled for Lymphoma

Media Library

CS5001 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05279300 — Phase 1
Lymphoma Research Study Groups: Dose expansion, Dose escalation
Lymphoma Clinical Trial 2023: CS5001 Highlights & Side Effects. Trial Name: NCT05279300 — Phase 1
CS5001 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05279300 — Phase 1
~22 spots leftby Mar 2025