RecruitingPhase 1/2

A Phase Ib/II Study to Evaluate Multiple Combination Therapies of FWD1802 in Patients With ER+/HER2- BC

China196 participantsStarted 2025-06-01

Plain-language summary

This is a Study to Evaluate the Efficacy and Safety of Multiple Combination Therapies with FWD1802 in Subjects with ER-positive/HER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer

Who can participate

Age range18 Years – 75 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Progression during/after, intolerance to, ineligibility for, or refusal of standard therapy
✓. Endocrine therapy history:
✓. ≤2 prior lines of chemotherapy for ABC
✓. No prior SERD (selective estrogen receptor degrader) therapy except fulvestrant
✓. Everolimus combination arm: Prior CDK4/6 inhibitor therapy requiredf) CDK4/6 inhibitor combination arm:Permitted ≤1 line of prior non-investigational CDK4/6 inhibitor therapy;If only received adjuvant CDK4/6 inhibitor therapy, recurrence must occur \>12 months after treatment completion Note: Antibody-drug conjugates (ADCs) are classified as chemotherapy in this study.

Exclusion criteria

✕. Interstitial lung disease or drug-induced ILD history, OR evidence of active pneumonitis on chest CT scan within 4 weeks prior to first study treatment.
✕. Severe pulmonary disease at screening, including but not limited to:Severe asthma;Severe chronic obstructive pulmonary disease (COPD) Idiopathic

What they're measuring

Phase Ib- Dose-Limiting Toxicity (DLT).

Timeframe: Approximately 1.5 years

Phase Ib- Maximum Tolerated Dose (MTD).

Timeframe: Approximately 1.5 years

Phase Ib- Recommended Phase II Dose (RP2D).

Timeframe: Approximately 1.5 years

Incidence of Treatment-Emergent Adverse Events (TEAEs)

Timeframe: Approximately 2 years

Severity Grading of Adverse Events

Timeframe: Approximately 2 years

Clinically Significant Abnormalities in 12-Lead ECG Parameters

Timeframe: Approximately 2 years

Vital Sign Abnormalities

Timeframe: Approximately 2 years

Serious Adverse Events (SAEs) Incidence

Timeframe: Approximately 2 years

Trial details

NCT IDNCT07002177

SponsorForward Pharmaceuticals Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-05-01

Contact for this trial

Jinglin Xu

18964533182 xujl@forward-pharm.com

View on ClinicalTrials.gov More Metastatic Breast Cancer trials

Who can participate

Age range18 Years – 75 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Progression during/after, intolerance to, ineligibility for, or refusal of standard therapy
✓. Endocrine therapy history:
✓. ≤2 prior lines of chemotherapy for ABC
✓. No prior SERD (selective estrogen receptor degrader) therapy except fulvestrant
✓. Everolimus combination arm: Prior CDK4/6 inhibitor therapy requiredf) CDK4/6 inhibitor combination arm:Permitted ≤1 line of prior non-investigational CDK4/6 inhibitor therapy;If only received adjuvant CDK4/6 inhibitor therapy, recurrence must occur \>12 months after treatment completion Note: Antibody-drug conjugates (ADCs) are classified as chemotherapy in this study.

Exclusion criteria

✕. Interstitial lung disease or drug-induced ILD history, OR evidence of active pneumonitis on chest CT scan within 4 weeks prior to first study treatment.
✕. Severe pulmonary disease at screening, including but not limited to:Severe asthma;Severe chronic obstructive pulmonary disease (COPD) Idiopathic

What they're measuring

Phase Ib- Dose-Limiting Toxicity (DLT).

Timeframe: Approximately 1.5 years

Phase Ib- Maximum Tolerated Dose (MTD).

Timeframe: Approximately 1.5 years

Phase Ib- Recommended Phase II Dose (RP2D).

Timeframe: Approximately 1.5 years

Incidence of Treatment-Emergent Adverse Events (TEAEs)

Timeframe: Approximately 2 years

Severity Grading of Adverse Events

Timeframe: Approximately 2 years

Clinically Significant Abnormalities in 12-Lead ECG Parameters

Timeframe: Approximately 2 years

Vital Sign Abnormalities

Timeframe: Approximately 2 years

Serious Adverse Events (SAEs) Incidence

Timeframe: Approximately 2 years