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Histone Deacetylase Inhibitor

CCS1477 for Solid Cancers

Phase 1 & 2

Recruiting

Led By Johann de Bono, MD

Research Sponsored by CellCentric Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG performance status 0-1

Be older than 18 years old

Must not have

Strong inhibitors of CYP3A4 or CYP3A4 substrates with a narrow therapeutic range taken within 2 weeks of the first dose of study treatment

Any evidence of severe or uncontrolled systemic diseases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

Approved for 10 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is testing a new drug to see if it is safe and effective for treating various types of cancer.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects of CCS1477 may include typical reactions seen with cancer treatments such as fatigue, digestive issues, changes in blood counts leading to increased infection risk or bleeding problems. Specific side effects will depend on individual patient responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't taken strong CYP3A4 inhibitors or sensitive substrates in the last 2 weeks.

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I do not have any severe or uncontrolled illnesses.

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I do not have any uncontrolled illnesses.

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I have not taken strong CYP3A4 inducers in the last 4 weeks.

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I haven't had major surgery or a serious injury in the last 4 weeks.

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I have a primary brain tumor or brain metastases.

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I haven't had extensive radiation therapy affecting more than 30% of my bone marrow in the last 4 weeks.

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I will stop taking statins before starting the study treatment.

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I haven't taken any cancer drugs or been in a trial for at least 14 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of treatment-related adverse events

Laboratory assessments

Secondary study objectives

AUC of CCS1477

CTC response

Cmax of CCS1477

+3 more

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Abiraterone acetate

2014

Completed Phase 3

~3440

Enzalutamide

2014

Completed Phase 4

~3820