A Phase 1b/2 Open-Label Study of Samuraciclib in Combination with Elacestrant in Participants with Metastatic or Locally Advanced Hormone-Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Breast Cancer

Conditions

Breast Cancer

Brief summary

• Phase 1b (Dose-finding): ): Identification of combination, Phase 2, expansion dose level. Dose- limiting toxicities and type, incidence, severity (as graded by CTCAE v5.0), seriousness, and relationship to study medications of AEs and any laboratory abnormalities, • Phase 2 (Expansion): PFS, defined as the time from enrollment until disease progression or death

Detailed description

• Type, incidence, severity (as graded by CTCAE v5.0), seriousness, and relationship to study medications of AEs and any laboratory abnormalities, • Clinical benefit response (CBR) 24 weeks (a complete or partial response, or stable disease (SD) for at least 24 weeks)., • Overall Response Rate (ORR), defined as the proportion of participants with a reduction in tumor burden (PR and/or CR in accordance with RECIST v1.1) of a predefined amount, • Duration of Response (DOR), defined as the time from documentation of tumor response (PR and/or CR) to disease progression., • Best percent change in tumor size., • Plasma concentrations and PK parameters of samuraciclib, • Plasma concentrations and PK parameters of elacestrant, • Correlations between ESR1 and TP53 mutations and efficacy/safety findings in this participant population

Related papers

No related papers found yet.

Interventions

DRUGCT7001

DRUGORSERDU 345 mg film-coated tablets

DRUGORSERDU 86 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
• Phase 1b (Dose-finding): ): Identification of combination, Phase 2, expansion dose level. Dose- limiting toxicities and type, incidence, severity (as graded by CTCAE v5.0), seriousness, and relationship to study medications of AEs and any laboratory abnormalities, • Phase 2 (Expansion): PFS, defined as the time from enrollment until disease progression or death	—

Secondary

Measure	Time frame
• Type, incidence, severity (as graded by CTCAE v5.0), seriousness, and relationship to study medications of AEs and any laboratory abnormalities, • Clinical benefit response (CBR) 24 weeks (a complete or partial response, or stable disease (SD) for at least 24 weeks)., • Overall Response Rate (ORR), defined as the proportion of participants with a reduction in tumor burden (PR and/or CR in accordance with RECIST v1.1) of a predefined amount, • Duration of Response (DOR), defined as the time from documentation of tumor response (PR and/or CR) to disease progression., • Best percent change in tumor size., • Plasma concentrations and PK parameters of samuraciclib, • Plasma concentrations and PK parameters of elacestrant, • Correlations between ESR1 and TP53 mutations and efficacy/safety findings in this participant population	—

Measure

Time frame

• Type, incidence, severity (as graded by CTCAE v5.0), seriousness, and relationship to study medications of AEs and any laboratory abnormalities, • Clinical benefit response (CBR) 24 weeks (a complete or partial response, or stable disease (SD) for at least 24 weeks)., • Overall Response Rate (ORR), defined as the proportion of participants with a reduction in tumor burden (PR and/or CR in accordance with RECIST v1.1) of a predefined amount, • Duration of Response (DOR), defined as the time from documentation of tumor response (PR and/or CR) to disease progression., • Best percent change in tumor size., • Plasma concentrations and PK parameters of samuraciclib, • Plasma concentrations and PK parameters of elacestrant, • Correlations between ESR1 and TP53 mutations and efficacy/safety findings in this participant population

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Countries

France, Spain

Outcome results

None listed