Health TrialsbyHealthPanel

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

ConditionsMetastatic Breast CancerBreast Cancer Stage IBreast Cancer Stage IILocally Advanced Breast Cancer (LABC)ER+ Breast Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorForward Pharmaceuticals Co., Ltd.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects consent to provide blood samples for centralized laboratory testing of ESR1 mutation status and other biomarkers.

Histologically or cytologically confirmed ER-positive/HER2-negative locally advanced or metastatic breast cancer

Subjects must meet at least one of the following criteria: postmenopausal or prior bilateral oophorectomy, or postmenopausal or Premenopausal/perimenopausal women must agree to receive and maintain approved luteinizing hormone-releasing hormone (LHRH) agonist therapy during study treatment

Progression during/after, intolerance to, ineligibility for, or refusal of standard therapy

Disqualifiers

Leptomeningeal metastasis (carcinomatous meningitis)；Spinal cord compression；Symptomatic or clinically unstable central nervous system (CNS) metastases；

History or any persistent chronic gastrointestinal disorders or other conditions of impaired absorption that may interfere with oral absorption of the investigational drug

Symptomatic visceral metastases , or clinically symptomatic and unstable effusions;Pleural effusion;Ascites;Pericardial effusion or Pulmonary lymphangitis carcinomatosa. Prior intracavitary infusion therapy should have more than 14 days of stabilization,

Prior therapy with any selective estrogen receptor degrader (SERD) or similar agents other than fulvestrant

Trial design

Design model

Parallel

Treatments tested in this trial

  • FWD1802

    Drug

    orally QD with 28 days each cycle, treatment till disease progression or intolerable toxicity or withdraw for other reasons

  • Palbociclib 125mg

    Drug

    Dose: 125 mg Route: Orally Frequency: Once daily (QD) Schedule: Administered for 21 consecutive days, followed by a 7-day treatment break (3-weeks-on/1-week-off), constituting a 28-day cycle

  • Ribociclib 200Mg Oral Tablet

    Drug

    Dose: 600 mg Route: Orally Frequency: Once daily (QD) Schedule: Administered for 21 consecutive days, followed by a 7-day treatment break, constituting a 28-day cycle

  • Abemaciclib 150 MG

    Drug

    Dose: 150 mg Route: Orally Frequency: BID Schedule: Everyday

  • Everolimus 10 mg

    Drug

    Dose: 10 mg Route: Orally Frequency: QD Schedule: Everyday

Treatment groups

196 Participants
are divided into 4 treatment groups
Group A: FWD1802 in combination with Palbociclib (CDK4/6 inhibitor) with or without LHRH agonist；Experimental treatment 2 interventions
Group B: FWD1802 in combination with Ribociclib (CDK4/6 inhibitor) with or without LHRH agonistExperimental treatment 2 interventions
Group C: FWD1802 in combination with Abemaciclib (CDK4/6 inhibitor) with or without LHRH agonistExperimental treatment 2 interventions
Group D: FWD1802 in combination with Everolimus (mTOR inhibitor) with or without LHRH agonistExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Phase Ib- Dose-Limiting Toxicity (DLT).

Time frame
Approximately 1.5 years
2

Phase Ib- Maximum Tolerated Dose (MTD).

Time frame
Approximately 1.5 years
3

Phase Ib- Recommended Phase II Dose (RP2D).

Time frame
Approximately 1.5 years
4

Incidence of Treatment-Emergent Adverse Events (TEAEs)

Number and proportion of participants experiencing any treatment-emergent adverse event during the study period. Assessment criteria: Events will be categorized as "related" or "unrelated" to study drug based on investigator's causality assessment. Reporting format: Frequency counts and percentages stratified by severity grade (Grade 1-5 as per NCI-CTCAE v5.0).

Time frame
Approximately 2 years

Secondary outcomes

1

Phase Ib- PK Assessment-Tmax

Time to Cmax (Tmax).

Time frame
Approximately 1.5 years
2

Phase Ib- PK Assessment-Cmax

Maximum plasma concentration (Cmax)

Time frame
Approximately 1.5 years
3

Phase Ib- PK Assessment-AUC0-t

Area under the concentration versus time curve from time 0 to the last measurable concentration (AUC0-t)

Time frame
Approximately 1.5 years
4

Phase Ib- PK Assessment-AUC0-inf

The area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-inf)

Time frame
Approximately 1.5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Forward Pharmaceuticals Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
Apply now