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New drug CCS1477 tested against tough solid tumors

NCT ID NCT03568656

Disease control Sponsor: CellCentric Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 25, 2026 · Last updated Sep 25, 2026

Summary

Researchers are running a phase 1/2a trial of an oral drug called CCS1477 in people with advanced solid tumors, including metastatic castration-resistant prostate cancer, metastatic breast cancer, and non-small cell lung cancer. The trial checks the safety and tolerability of CCS1477 when given alone and in combination with other cancer drugs such as abiraterone, enzalutamide, darolutamide, olaparib, and atezolizumab. Participants receive the study drug and undergo regular tests to monitor side effects and early signs of biological activity.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CCS1477, an experimental oral drug, tested alone and with other cancer drugs
What this could lead to
If CCS1477 proves safe and shows activity, it could become a new option for people with advanced prostate, breast, lung, or other solid tumors that have stopped responding to standard treatments.
What could go wrong
This is an early-phase trial with a limited number of participants, so safety and benefit are not yet established. CCS1477 may cause side effects or fail to shrink tumors, and the results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

219 people

The number who actually took part.

Started

Jul 2018

Finished

Jul 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Provision of consent * ECOG performance status 0-1 * Assessable disease (by CT, MRI, bone scan or X-ray) * Adequate organ function * Highly effective contraception measures for duration of study Additional inclusion criteria for mCRPC patients only: * Previously received abiraterone and/or enzalutamide (or equivalent anti-androgen), and docetaxel (unless ineligible or refused) * Progressive disease documented by one or more of the following: * Biochemical progression defined as at least 2 stepwise increases in a series of any 3 PSA values * Progression as defined by RECIST v1.1 guideline for assessment of malignant soft tissue disease. * Progression defined as two or more new metastatic bone lesions confirmed on bone scan from a previous assessment * PSA at screening ≥2 μg/L * Serum testosterone concentration ≤50 ng/dL * Serum albumin \>2.5 g/dL Additional inclusion criteria for patients in CCS1477 plus abiraterone combination arm: * Patients must have previously progressed on abiraterone treatment * Patients whose last dose of abiraterone is greater than 6 months prior to start of study treatment will receive a 4-week run-in treatment with abiraterone to confirm refractoriness to abiraterone treatment Additional inclusion criteria for patients in CCS1477 plus enzalutamide combination arm: * Patients must have previously progressed on enzalutamide treatment * Patients whose last dose of enzalutamide is greater than 6 months prior to start of study treatment will receive a 4-week run-in treatment with enzalutamide to confirm refractoriness to enzalutamide treatment Additional inclusion criteria for patients in mutation arm: * Advanced solid tumour with identification of markers which may indicate potential for response to p300/CBP inhibition. Markers include loss of function mutations in CREBBP, EP300 or ARID1A, MYC gene amplifications or rearrangements and androgen receptor (AR) gene amplifications or over-expression. Exclusion Criteria: * Intervention with any chemotherapy, investigational agents or other anti-cancer drugs within 14 days or 5 half-lives of the first dose * Radiotherapy with a wide field of radiation or to more than 30% of the bone marrow within 4 weeks of the first dose of study treatment * Major surgical procedure or significant traumatic injury within 4 weeks of the first dose of study treatment * Strong inhibitors of CYP3A4 or CYP3A4 substrates with a narrow therapeutic range taken within 2 weeks of the first dose of study treatment * Strong inducers of CYP3A4 within 4 weeks of the first dose of study treatment * Statins; patients should discontinue statins prior to starting study treatment * Any unresolved reversible toxicities from prior therapy \>CTCAE grade 1 at the time of starting study treatment * Any evidence of severe or uncontrolled systemic diseases * Any known uncontrolled inter-current illness * QTcF prolongation (\> 480 msec). * Primary brain tumours or known or suspected brain metastases. Additional exclusion criteria for patients in CCS1477 plus abiraterone combination arm: * Clinically significant cardiac abnormalities Additional exclusion criteria for patients in CCS1477 plus enzalutamide combination arm: * History of seizures or other predisposing factors * Use of substrates with a narrow therapeutic index metabolised by CYP2C9 or CYP2C19 within 2 weeks of the first dose of study treatment * Clinically significant cardiac abnormalities

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm castration-resistant prostate carcinoma non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid tumors Metastatic breast cancer Metastatic castration-resistant prostate cancer Non small cell lung cancer

Contacts and locations

Locations

  • Belfast City Hospital

    Belfast, BT9 7AB, United Kingdom

  • Cambridge University Hospital

    Cambridge, CB2 0QQ, United Kingdom

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Edinburgh Cancer Centre Western General Hospital

    Edinburgh, EH4 2XU, United Kingdom

  • Freeman Hospital

    Newcastle, NE7 7DN, United Kingdom

  • Hospital Vall d'Hebron, VHIO

    Barcelona, 08035, Spain

  • Hôpital Europeen Georges Pompidou

    Paris, 75015, France

  • Institute Bergonie

    Bordeaux, 33000, France

  • Institute Gustave Roussy

    Villejuif, 94805, France

  • Karolinska Institute

    Stockholm, 171 76, Sweden

  • Leicester Royal Infirmary

    Leicester, LE1 5WW, United Kingdom

  • Netherlands Cancer Institute (NKI)

    Amsterdam, 1066 CX, Netherlands

  • Queen Elizabeth Hospital Cancer Centre

    Birmingham, B15 2TH, United Kingdom

  • Royal Marsden Hospital

    Sutton, SM2 5NG, United Kingdom

  • START CIOCC Hospital Universitario HM

    Madrid, 28050, Spain

  • The Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN, United Kingdom

  • The Christie Hospital

    Manchester, M20 4BX, United Kingdom

  • Thomas Jefferson University, Sidney Kimmel Cancer Center

    Philadelphia, Pennsylvania, 19107, United States

  • University Hospital Southampton

    Southampton, SO16 6YD, United Kingdom

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