350 Participants Needed

CCS1477 for Solid Cancers

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)

Trial Summary

What is the purpose of this trial?

A Phase 1/2a study to assess the safety, tolerability, PK and biological activity of CCS1477 in patients with metastatic castration resistant prostate cancer, metastatic breast cancer, non-small cell lung cancer or advanced solid tumours.

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.

What makes the drug CCS1477 unique for treating solid cancers?

CCS1477, also known as Inobrodib, is unique because it targets specific proteins involved in cancer cell growth and survival, potentially offering a novel approach compared to traditional chemotherapy or other targeted therapies. Its mechanism of action and potential to be combined with immune-based therapies could provide new treatment options for patients with solid cancers.12345

Research Team

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Johann de Bono, MD

Principal Investigator

Royal Marsden NHS Foundation Trust

Eligibility Criteria

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

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

Treatment Details

Interventions

  • CCS1477
Trial OverviewThe 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.
Participant Groups
8Treatment groups
Experimental Treatment
Group I: CCS1477 expansion phase - mCRPCExperimental Treatment1 Intervention
CCS1477 monotherapy in patients with mCRPC
Group II: CCS1477 dose escalation - mCRPCExperimental Treatment1 Intervention
CCS1477 monotherapy in patients with mCRPC
Group III: CCS1477 and olaparib, combination dose finding and expansion - mCRPC and metastatic breast cancerExperimental Treatment2 Interventions
CCS1477 plus olaparib in patients with mCRPC or metastatic breast cancer.
Group IV: CCS1477 and enzalutamide, combination dose finding and expansion - mCRPCExperimental Treatment2 Interventions
CCS1477 plus enzalutamide in patients with mCRPC
Group V: CCS1477 and darolutamide, combination dose finding and expansion - mCRPCExperimental Treatment2 Interventions
CCS1477 plus darolutamide in patients with mCRPC
Group VI: CCS1477 and atezolizumab, combination dose finding and expansion - non-small cell lung cancerExperimental Treatment2 Interventions
CCS1477 plus atezolizumab in patients with non-small cell lung cancer
Group VII: CCS1477 and abiraterone acetate, combination dose finding and expansion - mCRPCExperimental Treatment2 Interventions
CCS1477 plus abiraterone acetate in patients with mCRPC
Group VIII: CCS1477 Monotherapy - Solid tumoursExperimental Treatment1 Intervention
CCS1477 expansion phase in patients with advanced solid tumours with molecular markers which may indicate potential for response to p300/CBP inhibition

Find a Clinic Near You

Who Is Running the Clinical Trial?

CellCentric Ltd.

Lead Sponsor

Trials
3
Recruited
620+

References

Microtubule-depolymerizing agents used in antibody-drug conjugates induce antitumor immunity by stimulation of dendritic cells. [2021]
ONC201 and an MEK Inhibitor Trametinib Synergistically Inhibit the Growth of Triple-Negative Breast Cancer Cells. [2021]
Research advances and new challenges in overcoming triple-negative breast cancer. [2022]
Targeted Therapies and the Evolving Standard of Care for Triple-Negative and Germline BRCA1/2-Mutated Breast Cancers in the High-Risk, Early-Stage Setting. [2023]
Dissecting the heterogeneity of triple-negative breast cancer. [2022]