CCS1477 for Solid Cancers

No longer recruiting at 18 trial locations
KC
TK
Overseen ByTomasz Knurowski, MD, MFPM
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: CellCentric Ltd.
Must be taking: Abiraterone, Enzalutamide
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 treatment called CCS1477 (also known as Inobrodib) to determine its safety and effectiveness for people with certain advanced cancers. The trial targets patients with metastatic prostate cancer, breast cancer, lung cancer, or other advanced solid tumors. It includes various groups, with some patients receiving CCS1477 alone and others combining it with existing drugs like abiraterone or enzalutamide. Eligible participants have advanced cancer that hasn't responded well to treatments like abiraterone or enzalutamide. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

You may need to stop taking certain medications before joining the trial. Specifically, you must stop taking statins and any strong inhibitors or inducers of CYP3A4. If you are on chemotherapy, investigational agents, or other anti-cancer drugs, you need to stop them at least 14 days before the trial starts.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that CCS1477 has been tested in over 400 patients and is safe and well-tolerated. This treatment is being combined with other drugs for various cancer types. For instance, studies indicate that combining it with abiraterone acetate and enzalutamide in patients with advanced prostate cancer is generally safe.

Darolutamide also maintains a good safety record for these prostate cancer patients. Olaparib, another drug combined with CCS1477, has been studied for safety in patients with specific genetic backgrounds. When CCS1477 is used with atezolizumab for lung cancer, some immune-related side effects have been noted, but most were manageable.

Overall, these combinations remain under study to confirm their safety, but current data suggest they are well-tolerated. Prospective participants should consider these findings and discuss any concerns with their healthcare provider.12345

Why are researchers excited about this trial's treatments?

CCS1477 is unique because it targets the p300/CBP proteins, which play a crucial role in cancer cell growth and survival, offering a new mechanism of action compared to standard treatments like hormone therapies or chemotherapy. Researchers are excited about CCS1477 because it can be combined with existing drugs like abiraterone, enzalutamide, darolutamide, and olaparib, potentially enhancing their effectiveness against metastatic castration-resistant prostate cancer (mCRPC) and other solid tumors. Unlike current treatments that primarily focus on hormone pathways or DNA damage response separately, CCS1477 may provide a more comprehensive approach by interfering with cancer cell signaling and growth regulation.

What evidence suggests that this trial's treatments could be effective for solid cancers?

Research has shown that CCS1477 may help treat castration-resistant prostate cancer (CRPC) by targeting proteins called p300/CBP, which aid cancer cell growth. Studies have found that CCS1477 can reduce levels of KLK3, a marker linked to prostate cancer, and manage important cancer-related indicators in CRPC. In this trial, some participants will receive CCS1477 with drugs like abiraterone, enzalutamide, or darolutamide, potentially enhancing its effectiveness by blocking pathways cancer cells use to survive. Other participants will receive CCS1477 combined with olaparib, which is under study for its potential effectiveness in treating prostate and breast cancer, especially when these cancers have certain genetic changes. Additionally, the combination of CCS1477 with atezolizumab (an immune therapy) is being explored for non-small cell lung cancer, as it might enhance the immune system's ability to fight cancer cells. Overall, CCS1477 targets key cancer processes, and early evidence suggests it could effectively treat several types of advanced cancers.678910

Who Is on the Research Team?

Jd

Johann de Bono, MD

Principal Investigator

Royal Marsden NHS Foundation Trust

Are You a Good Fit for This Trial?

This trial is for adults with advanced prostate, breast, non-small cell lung cancer or solid tumors. Participants must have specific genetic markers indicating a potential response to treatment and meet health criteria like good organ function and performance status. They should not have severe diseases, unresolved toxicities from past therapies, or be taking certain drugs that could interfere with the study.

Inclusion Criteria

My advanced cancer has specific genetic changes that may respond to a new treatment.
I have mCRPC and have been treated with abiraterone, enzalutamide, or docetaxel.
Your disease can be measured using CT, MRI, bone scan, or X-ray.
See 7 more

Exclusion Criteria

I haven't taken strong CYP3A4 inhibitors or sensitive substrates in the last 2 weeks.
I do not have any severe or uncontrolled illnesses.
I don't have lasting side effects from previous treatments above mild.
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CCS1477 as monotherapy or in combination with other drugs for advanced solid/metastatic tumours

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • CCS1477
Trial Overview The trial is testing CCS1477's safety and effectiveness in patients with advanced cancers who've had treatments like abiraterone or enzalutamide for prostate cancer but saw their disease progress. It involves assessing how well the body handles the drug (pharmacokinetics) and its biological impact on tumor activity.
How Is the Trial Designed?
8Treatment groups
Experimental Treatment
Group I: CCS1477 expansion phase - mCRPCExperimental Treatment1 Intervention
Group II: CCS1477 dose escalation - mCRPCExperimental Treatment1 Intervention
Group III: CCS1477 and olaparib, combination dose finding and expansion - mCRPC and metastatic breast cancerExperimental Treatment2 Interventions
Group IV: CCS1477 and enzalutamide, combination dose finding and expansion - mCRPCExperimental Treatment2 Interventions
Group V: CCS1477 and darolutamide, combination dose finding and expansion - mCRPCExperimental Treatment2 Interventions
Group VI: CCS1477 and atezolizumab, combination dose finding and expansion - non-small cell lung cancerExperimental Treatment2 Interventions
Group VII: CCS1477 and abiraterone acetate, combination dose finding and expansion - mCRPCExperimental Treatment2 Interventions
Group VIII: CCS1477 Monotherapy - Solid tumoursExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

CellCentric Ltd.

Lead Sponsor

Trials
3
Recruited
620+

Citations

Targeting p300/CBP in lethal prostate cancer - PMCEarly clinical studies suggest that CCS1477 modulates KLK3 blood levels and regulates CRPC biopsy biomarker expression. Overall, CCS1477 shows promise for the ...
AR coactivators, CBP/p300, are critical mediators of DNA ...Key findings demonstrate that CBP/p300 expression increases with disease progression and selects for poor prognosis in metastatic disease. CBP/ ...
CellCentric enters clinic with first-in-class p300/CBP inhibitor ...CCS1477 has relevance to multiple cancer types, and notably for late-stage, castration-resistant prostate cancer (CRPC). It addresses the large and growing ...
CBP/p300, a promising therapeutic target for prostate cancerHowever, although ADT can significantly improve prognosis and increase survival rates in early PCa, nearly all patients eventually progress to ...
A Randomized Phase 2 Study Evaluating Abiraterone Acetate ...A Randomized Phase 2 Study Evaluating Abiraterone Acetate With Different Steroid Regimens for Preventing Symptoms Associated With Mineralocorticoid Excess in ...
6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/40940844/
The Safety of Abiraterone Acetate in Patients with Metastatic ...The Safety of Abiraterone Acetate in Patients with Metastatic Castration-Resistant Prostate Cancer: An Individual-Participant Data Meta ...
The Safety of Abiraterone Acetate in Patients with ...This study was conducted in order to determine the most common serious adverse events that occur in patients with metastatic castration-resistant prostate ...
Review – Prostate Cancer Novel Therapeutic Strategies for ...Several drugs are approved for metastatic castration-resistant PCa (mCRPC), including ARPIs, taxanes targeting tubulin, and DNA damage inducing radioligand ...
An open-label Phase I/IIa study to evaluate the safety and ...A Phase 1/2a study to assess the safety, tolerability, PK and biological activity of CCS1477 in patients with metastatic castration resistant prostate cancer.
An Individual-Participant Data Meta-Analysis Based on 14 ...... Safety of. Abiraterone Acetate in Patients with. Metastatic Castration-Resistant. Prostate Cancer: An Individual-. Participant Data Meta- ...
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