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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up about up to 12 months
Awards & highlights

Study Summary

This trial is testing an experimental drug to see if it is safe and effective in treating patients with advanced cancer.

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.Check my eligibility
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.See study design
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.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I have Hodgkin or B-cell non-Hodgkin lymphoma that has worsened after 2 treatments.
Select...
I have MCL, DLBCL, or TNBC and have had at least two treatments, including one for MCL.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~about up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and about up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incident and severity of adverse events
Maximum Tolerated Dose (MTD) of CS5001 if any (for dose escalation part)
Recommended Phase 2 Dose(RP2D) of CS5001 (for dose escalation part)
Secondary outcome measures
Concentration of CS5001 total antibody, prodrug and the free cytotoxin
Concentration of anti-CS5001 antibodies
Other outcome measures
Anti-tumor activity of CS5001 at RP2D in patient with selected advanced cancers (For dose expansion part)

Trial Design

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

Find a Location

Who is running the clinical trial?

CStone PharmaceuticalsLead Sponsor
26 Previous Clinical Trials
3,825 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor actively recruiting participants?

"Affirmative. Clinicaltrials.gov data shows that this study is actively seeking out 156 participants across 3 trial sites, with the original posting being on March 28th 2022 and last edited June 20th 2022."

Answered by AI

How many participants has this research attracted so far?

"Affirmative. Clinicaltrials.gov highlights that this medical study, which was posted on March 28th 2022, is actively recruiting for 156 volunteers from 3 sites. This data was last updated on June 20th 2022."

Answered by AI

Has CS5001 acquired the necessary certification from the Food and Drug Administration?

"Because of the limited data backing CS5001's safety and efficacy, our team has rated it a 1 on a scale from 1 to 3."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of CS5001 in Patients With Advanced Solid Tumors and Lymphomas
2022. "A Study of CS5001 in Patients With Advanced Solid Tumors and Lymphomas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05279300.
~48 spots leftby Mar 2025
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