CS2009 for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new potential drug, CS2009, to determine its safety and effectiveness for individuals with advanced solid tumors, such as certain lung, kidney, liver, stomach, ovarian, or cervical cancers. Researchers aim to identify the optimal dose and evaluate its efficacy alone or in combination with other treatments like chemotherapy. Participants should have a solid tumor that cannot be surgically removed and must have previously tried standard treatments without success. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Is there any evidence suggesting that CS2009 is likely to be safe for humans?
Research has shown that CS2009 has been generally safe in past studies. For example, no serious side effects were found that would prevent dose escalation across six different dose levels. However, some patients did experience significant side effects. About 24.6% of patients had more severe side effects, classified as Grade 3 or higher. Additionally, 12.7% of patients experienced immune-related side effects. These findings suggest that while CS2009 is usually well-tolerated, it can cause serious side effects in some patients.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about CS2009 for cancer treatment because it offers a new approach by potentially targeting cancer cells more precisely. Unlike traditional chemotherapy, which attacks both cancerous and healthy cells, CS2009 is designed to hone in on cancer cells, possibly reducing side effects. Additionally, the trial includes a dose escalation phase to determine the optimal dosage, which could enhance its effectiveness when combined with chemotherapy in the dose expansion phase. This targeted strategy may lead to more efficient treatments with fewer adverse effects, making it a promising option for cancer therapy advancements.
What evidence suggests that CS2009 might be an effective treatment for cancer?
Research has shown that CS2009 holds promise for treating advanced solid tumors. One study demonstrated that using CS2009 alone led to significant improvement in 81.3% of patients, with all patients experiencing some level of disease control. Specifically, for a certain type of lung cancer, 90% of patients showed improvement, and everyone experienced disease control. These results suggest that CS2009, which targets several pathways that aid tumor growth, could be a strong option for cancer treatment. The treatment has also proven safe, with no deaths related to it. Overall, early data supports its potential effectiveness in managing advanced solid tumors. Participants in this trial will receive CS2009 in either a dose escalation or dose expansion format, with the latter potentially including chemotherapy based on dose-escalation data.12678
Are You a Good Fit for This Trial?
This trial is for adults with advanced solid tumors (like lung, kidney, liver, stomach, ovarian, or cervical cancer) that can't be removed by surgery and have not responded to standard treatments. Participants must be in good physical condition and have working major organs.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants will be administered escalating doses of CS2009 to determine the maximum tolerated dose
Dose Expansion
Participants will receive the recommended dose(s) of CS2009 with or without chemotherapy based on dose-escalation data
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- CS2009
Trial Overview
The study tests a new drug called CS2009 alone or combined with various chemotherapy drugs to find the safest dose and see how well it works against advanced cancers. It has two parts: first testing different doses, then expanding to more patients at selected doses.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants will be administered the recommended dose(s) of CS2009 with or without chemotherapy according to dose-escalation data.
Participants will be administered escalating doses of CS2009.
Find a Clinic Near You
Who Is Running the Clinical Trial?
CStone Pharmaceuticals
Lead Sponsor
Citations
CStone Presents Updated Clinical Data for CS2009 (PD-1/ ...
CS2009 monotherapy achieved an objective response rate (ORR) of 81.3% and a disease control rate (DCR) of 100.0%, with consistent benefit ...
Safety and efficacy of CS2009, a first-in-class PD-1/VEGF/ ...
No treatment-related deaths were reported. TRAEs led to discontinuation in 3 (7.5%) pts. meaningful anti-tumor activity
CStone Presents Updated Clinical Data for CS2009 (PD-1/ ...
CS2009 monotherapy achieved an objective response rate (ORR) of 81.3% and a disease control rate (DCR) of 100.0%, with consistent benefit ...
CStone Updated Clinical Progress and Key Phase I/II Data ...
CS2009 monotherapy (20 mg/30 mg, Q3W) achieved an ORR of 90% (9/10) and a DCR of 100% (10/10) in first-line NSCLC patients with PD-L1 TPS≥50% ( ...
CS2009, a novel PD-1/VEGF/CTLA-4 trispecific antibody, ...
Initial data from this phase 1 study showed a favorable safety profile and encouraging antitumor activity. Here, we report updated safety and ...
CStone Updated Clinical Progress and Key Phase I/II Data ...
CS2009 demonstrates a favorable safety and tolerability profile across all six dose levels evaluated, with no dose-limiting toxicities (DLTs) ...
CS2009 / CStone Pharma
CS2009 exhibits a favorable early safety profile and signals of antitumor activity, supporting further clinical development."
8.
bioanalysis-zone.com
bioanalysis-zone.com/fda-clears-phase-ii-study-of-cstone-pharmaceuticals-trispecific-antibody/FDA Clears Phase II Study of CStone Pharmaceuticals ...
Initial Phase I data for CS2009, demonstrated a favorable safety profile with encouraging antitumor activities. safety and antitumor activity ...
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