CP-383 for Cancer

Recruiting at 6 trial locations

Overseen By Tasca Therapeutics

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Tasca Therapeutics

Must not be taking: Anti-cancer drugs

Disqualifiers: Brain tumor, HIV, Liver disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: Until disease progression or unacceptable toxicity

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the investigational drug CP-383 can slow or stop the growth of advanced cancers. It aims to determine the optimal dose of CP-383 and assess its safety, while also examining if cancers with certain gene mutations respond better. Participants will take CP-383 orally each day and visit the clinic regularly for check-ups. The trial seeks individuals with advanced or metastatic cancers (cancers that have spread) that have not responded to standard treatments, excluding brain cancers.

As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications to join the trial?

The trial information does not clearly state if you need to stop your current medications. However, it mentions that exposure to certain anti-cancer or other drugs before starting the study drug may exclude you from participating. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that CP-383 is likely to be safe for humans?

Previous studies have examined the safety of CP-383 for people with advanced cancer. Reports show that CP-383 is generally well-tolerated, with most people experiencing no serious side effects. When side effects occur, they are usually mild, such as nausea or fatigue, which are common with many cancer treatments. As this trial is in its early stages, researchers continue to study the safety of CP-383 at various doses. Participants in this trial will help determine the optimal dose that balances effectiveness with safety.

This trial tests several dose levels, ranging from 0.8 mg to 12 mg. By exploring different doses, researchers aim to identify the safest and most effective dose for future studies. Those considering joining the trial should know that ongoing studies focus on closely monitoring safety and side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for cancer?

Unlike standard cancer treatments like chemotherapy or radiation, CP-383 is an oral capsule that could offer a more convenient and potentially less invasive option for patients. Researchers are excited because CP-383 works by targeting specific cancer pathways, which might lead to fewer side effects compared to traditional treatments. Additionally, the trial explores various dosage levels to optimize effectiveness while minimizing risks, potentially paving the way for personalized cancer therapy.

What evidence suggests that CP-383 might be an effective treatment for advanced cancer?

Research shows that CP-383 targets a key pathway involved in several difficult-to-treat cancers. Early studies in labs, particularly with models of triple-negative breast and prostate cancer, have shown promising results. These studies suggest that CP-383 can effectively slow or stop cancer growth. This small drug is designed to interfere with specific processes that cancer cells need to grow. While research in humans continues, these early findings offer hope for CP-383's potential in treating advanced cancers. Participants in this trial will receive different doses of CP-383 to evaluate its safety and effectiveness. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with advanced cancers like colorectal, lung, pancreatic, bladder, and head & neck cancer who can't take standard treatments or haven't been helped by them. They need a tumor sample available and must use effective birth control. It's not for those with brain cancer.

Inclusion Criteria

My cancer can be monitored for changes by the research team.

* Availability of a part of a tumor for laboratory testing or willing to have a safe biopsy taken from a tumor * Diagnosed with locally advanced, recurrent or metastatic incurable disease

I cannot take or am not eligible for standard cancer treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take CP-383 daily by mouth and visit the clinic weekly for the first 6 weeks, then every 3 weeks for checkups and tests

Until disease progression or unacceptable toxicity

Weekly visits for 6 weeks, then every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• CP-383

Trial Overview The study tests CP-383 to see if it slows or stops advanced cancer growth when taken daily by mouth. Participants will have regular clinic visits for checkups and tests to find the best dose of CP-383 and if certain gene mutations in tumors respond better.

How Is the Trial Designed?

Group I: Expansion Arm 4 Experimental Treatment 1 Intervention

Expansion in selected tumor type at recommended Phase 2 Dose of CP-383

Group II: Expansion Arm 3 Experimental Treatment 1 Intervention

Expansion in selected tumor type at recommended Phase 2 Dose of CP-383

Group III: Expansion Arm 2 Experimental Treatment 1 Intervention

Expansion in selected tumor type at recommended Phase 2 Dose of CP-383

Group IV: Expansion Arm 1 Experimental Treatment 1 Intervention

Expansion in selected tumor type at recommended Phase 2 Dose of CP-383

Group V: Dose Level 6 Experimental Treatment 1 Intervention

CP-383, single daily oral capsule, 12 mg

Group VI: Dose Level 5 Experimental Treatment 1 Intervention

CP-383, single daily oral capsule, 8.0 mg

Group VII: Dose Level 4 Experimental Treatment 1 Intervention

CP-383, single daily oral capsule, 5.0 mg

Group VIII: Dose Level 3 Experimental Treatment 1 Intervention

CP-383, single daily oral capsule, 3.0 mg

Group IX: Dose Level 2 Experimental Treatment 1 Intervention

CP-383, single daily oral capsule, 1.6 mg

Group X: Dose Level 1 Experimental Treatment 1 Intervention

CP-383, single daily oral capsule, 0.8 mg

Who Is Running the Clinical Trial?

Tasca Therapeutics

Lead Sponsor

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07030257

Study of CP-383 in Patients With Advanced or Metastatic ... The goal of this clinical trial is to learn if an investigational drug CP-383 works to treat advanced cancer. It will also learn about the safety of CP-383.

2. bcan.org bcan.org/clinicaltrials/cp-383-in-patients-with-advanced-or-metastatic-solid-tumors/

CP-383 in Patients With Advanced or Metastatic Solid ... The goal of this clinical trial is to learn if an investigational drug CP-383 works to treat advanced cancer. It will also learn about the safety of CP-383.

3. tascatx.com tascatx.com/sept-18-press

Sept 18 - Press Release — Tasca Therapeutics “CP-383 is a highly differentiated small molecule that targets a key pathway implicated in multiple difficult-to-treat cancers. We are looking forward to ...

4. withpower.com withpower.com/trial/phase-2-small-cell-lung-carcinoma-7-2025-6adf6

CP-383 for Cancer · Recruiting Participants for Phase ... The goal of this clinical trial is to learn if an investigational drug CP-383 works to treat advanced cancer. It will also learn about the safety of CP-383.

5. linkedin.com linkedin.com/posts/tsc1_oncology-clinicaltrials-innovation-activity-7374029108235739136-d4hm

Tasca Therapeutics starts Phase I/II trial of CP-383, raises ... These results build on previously reported findings in triple-negative breast and prostate cancer models, reinforcing Telomir-1's consistent ...

6. ctv.veeva.com ctv.veeva.com/study/study-of-cp-383-in-patients-with-advanced-or-metastatic-solid-tumors

Study of CP-383 in Patients With Advanced or Metastatic Solid ... The goal of this clinical trial is to learn if an investigational drug CP-383 works to treat advanced cancer. It will also learn about the ...

7. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.7531

Efficacy, safety, and determination of RP2D of ABBV-383, a ... Here, safety and efficacy results are reported that support the RP2D of 60mg Q4W as the optimal therapeutic ABBV-383 monotherapy dose. Methods: ...