800 Participants NeededMy employer runs this trial

CS2009 for Cancer

Recruiting at 32 trial locations
WZ
JW
Overseen ByJingru Wang
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

I am fully active or restricted in physically strenuous activity only.
My organs are working well enough for treatment.
I am willing to use birth control during and after the study as required.
See 8 more

Exclusion Criteria

I have not had another active cancer in the past 3 years, except for cured local cancers.
I have not received a live vaccine in the past 28 days.
I have had lung inflammation needing steroids or currently have lung inflammation.
See 18 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants will be administered escalating doses of CS2009 to determine the maximum tolerated dose

Up to 21 days per cycle
1 visit per cycle (in-person)

Dose Expansion

Participants will receive the recommended dose(s) of CS2009 with or without chemotherapy based on dose-escalation data

Varies based on cycles

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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

Group I: Dose ExpansionExperimental Treatment14 Interventions
Group II: Dose EscalationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

CStone Pharmaceuticals

Lead Sponsor

Trials
28
Recruited
4,100+

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."

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 ...