Study to Evaluate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of CC-94676 in Subjects With Metastatic Castration-Resistant Prostate Cancer

STATUS

Recruiting
End date

Jun 29, 2026
participants needed

40
sponsor

Celgene

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Updated on 19 February 2024

See if I qualify

cancer

hormone therapy

adenocarcinoma

endocrine therapy

luteinizing hormone

gonadotropin releasing hormone

gonadotropin

testosterone

androgens

bilateral orchidectomy

abiraterone

enzalutamide

serum testosterone

antiandrogen therapy

orchiectomy

adenocarcinoma of prostate

androgen suppression

metastatic castration-resistant prostate cancer

apalutamide

darolutamide

gonadorelin

castration-resistant prostate cancer

prostate cancer

metastatic hormone refractory prostate cancer

Summary

This is a first in human study to assess the safety, tolerability, PK, PD and preliminary efficacy of CC-94676 in men with progressive metastatic castration-resistant prostate cancer.

Description

Study CC-94676-PCA-001 is a first-in-human dose finding study to determine the safety, tolerability, PK, PD, and preliminary efficacy of CC-94676 in subjects with mCRPC who have progressed on ADT and at least one prior secondary hormonal therapy approved for CRPC (eg, abiraterone, enzalutamide, apalutamide, or darolutamide). The dose escalation will evaluate the safety and tolerability of escalating doses of CC-94676 in mCRCP subjects to determine the MTD of CC-94676. The dose expansion will further evaluate the safety and preliminary efficacy of CC-94676 administered at or below MTD in subjects with mCRPC.

Details

Condition	Malignant neoplasm of prostate, Prostatic disorder
Age	18years - 100years
Treatment	CC-94676
Clinical Study Identifier	NCT04428788
Sponsor	Celgene
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Subjects must satisfy the following criteria to be enrolled in the study
	Subject is a male 18 years of age at the time of signing the informed consent form (ICF)
	Subjects must have histologically or cytologically confirmed adenocarcinoma of the prostate
	Subjects must have documented progressive metastatic castration-resistant prostate cancer (CRPC)
	Subjects must have progressed on androgen deprivation therapy (ADT) and at least one prior secondary hormonal therapy approved for CRPC (eg, abiraterone, enzalutamide, apalutamide, or darolutamide)
	Subjects must have serum testosterone 50 ng/dL. Subjects must continue primary androgen deprivation with a luteinizing hormone-releasing hormone (LHRH) analogue (agonist or antagonist) if they have not undergone bilateral orchiectomy
Exclusion Criteria
	The presence of any of the following will exclude a subject from enrollment
	Subject has confirmed or suspected small cell carcinoma of the prostate/neuroendocrine prostate cancer
	Subject has known symptomatic brain or epidural central nervous system (CNS) or spinal metastases requiring steroids (above physiologic replacement doses) or radiation
	Subject had systemic anticancer therapy or investigational treatments within 4 weeks (except treatments to maintain castrate status) or 5 half-lives prior to the first dose of CC-94676, whichever is shorter
	Subject had palliative radiation, strontium-89, or radium-223 4 weeks prior to the first dose of CC-94676. Palliative radiation for the alleviation of pain due to bone metastasis will be allowed during the study, as long as this is not a sign of clinically significant disease progression
	Subject has any significant medical condition, such as uncontrolled infection, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study

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Study Definition

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Study to Evaluate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of CC-94676 in Subjects With Metastatic Castration-Resistant Prostate Cancer