CClinicalTrials.gg
Sign In
RecruitingNCT07002177Updated Jan 7, 2026

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

A Phase 1/2 interventional study of FWD1802 and Palbociclib 125mg in Metastatic Breast Cancer, Breast Cancer Stage I and Breast Cancer Stage II, sponsored by Forward Pharmaceuticals Co., Ltd.. Recruiting at 1 site in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-01-07.

Sponsored by Forward Pharmaceuticals Co., Ltd. · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2025; still recruiting 1 year 4 months later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
196
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
Female
01

Study 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

02

Conditions studied

  • Metastatic Breast Cancer
  • Breast Cancer Stage I
  • Breast Cancer Stage II
  • Locally Advanced Breast Cancer (LABC)
  • ER+ Breast Cancer

Browse trials for

03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 196 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Forward Pharmaceuticals Co., Ltd. is the lead sponsor of 4 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • 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

  • Prior Therapy Requirements:Subjects must meet all of the following criteria:

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

    2. Endocrine therapy history:

      Recurrence during or within 1 year after completing ≥2 years of adjuvant endocrine therapy;OR progression after ≥1 line of endocrine therapy for advanced breast cancer(ABC) with ≥6 months of maintenance therapy (no restriction on the number of prior endocrine therapy lines).

    3. ≤2 prior lines of chemotherapy for ABC
    4. No prior SERD (selective estrogen receptor degrader) therapy except fulvestrant
    5. 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.
  • Phase Ib: At least one evaluable lesion per RECIST v1.1, allowed subjects with osteolytic bone lesion(s) confirmed by CT/MRI.Phase II: At least one measurable lesion per RECIST v1.1.

Subject must have sufficient organ and bone marrow functions at screening.

Exclusion criteria

Exclusion Criteria:

  • 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
  • Inadequate washout period for prior anticancer therapies.
  • Type 1 diabetes mellitus; Type 2 diabetes mellitus with poor glycemic control at screening(applies only to the everolimus combination arm).

  • Subjects will be excluded if they meet any of the following:

    1. 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.
    2. Severe pulmonary disease at screening, including but not limited to:Severe asthma;Severe chronic obstructive pulmonary disease (COPD) Idiopathic
  • Uncontrolled hypertension despite antihypertensive therapy, defined as:Systolic blood pressure (SBP) >150 mmHg OR Diastolic blood pressure (DBP) >95 mmHg.
  • Active cardiac disease or history of cardiac dysfunction
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
196 participants (estimated)

Study arms

  • Experimental
    FWD1802 in combination with Palbociclib (CDK4/6 inhibitor) with or without LHRH agonist；

    Drug: FWD1802 · Drug: Palbociclib 125mg

  • Experimental
    FWD1802 in combination with Ribociclib (CDK4/6 inhibitor) with or without LHRH agonist

    Drug: FWD1802 · Drug: Ribociclib 200Mg Oral Tablet

  • Experimental
    FWD1802 in combination with Abemaciclib (CDK4/6 inhibitor) with or without LHRH agonist

    Drug: FWD1802 · Drug: Abemaciclib 150 MG

  • Experimental
    FWD1802 in combination with Everolimus (mTOR inhibitor) with or without LHRH agonist

    Drug: FWD1802 · Drug: Everolimus 10 mg

Interventions

  • DrugFWD1802

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

  • DrugPalbociclib 125mg

    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

  • DrugRibociclib 200Mg Oral Tablet

    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

  • DrugAbemaciclib 150 MG

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

  • DrugEverolimus 10 mg

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

06

What researchers measure

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

  5. Severity Grading of Adverse Events

    Maximum severity grade of treatment-emergent adverse events experienced by participants. Assessment tool: National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Reporting format: Proportion of participants with events in each severity category (Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=life-threatening; Grade 5=death).

    Time frame: Approximately 2 years

  6. Clinically Significant Abnormalities in 12-Lead ECG Parameters

    Number of participants with clinically significant changes in electrocardiogram parameters from baseline. Assessed parameters: QTc interval, PR interval, QRS duration, heart rate.

    Time frame: Approximately 2 years

  7. Vital Sign Abnormalities

    Proportion of participants with clinically significant deviations in vital signs: Parameters: Systolic/diastolic blood pressure (mmHg), heart rate (bpm), respiratory rate (breaths/min), body temperature (°C).

    Time frame: Approximately 2 years

  8. Serious Adverse Events (SAEs) Incidence

    Time frame: Approximately 2 years

  9. Phase II- Investigator-assessed Objective Response Rate (ORR) based on RECIST v1.1.

    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

  5. Phase Ib- PK Assessment-t1/2

    elimination half-life time (t1/2)

    Time frame: Approximately 1.5 years

  6. Efficacy Assessment-ORR

    Tumor response assessments by the corresponding criteria by RECIST v1.1 to assess Objective response rate (ORR)

    Time frame: Approximately 2 years

  7. Efficacy Assessment-CBR

    Clinical benefit rate (CBR)

    Time frame: Approximately 2 years

  8. Efficacy Assessment-DOR

    Duration of response (DoR）

    Time frame: Approximately 2 years

  9. Efficacy Assessment-DCR

    Disease control rate (DCR)

    Time frame: Approximately 1.5 years

  10. Efficacy Assessment-PFS

    Progression-free survival (PFS) by IRC according to RECIST 1.1.PFS is defined as time from the first dose until disease progression or death from any cause, whichever occurs first.

    Time frame: Approximately 2 years

  11. Efficacy Assessment-OS

    Overall survival (OS).OS is defined as time from date of the first dose to date of death due to any cause.

    Time frame: Approximately 2 years

  12. Pharmacokinetic (PK) Parameters:Plasma Concentration at Each Sampling Time Point.

    Time frame: Approximately 2 years

07

Study locations

1 of 1 sites recruiting
  • Fudan University Shanghai Cancer Center, Shanghai
    Shanghai, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07002177
Lead sponsor
Forward Pharmaceuticals Co., Ltd.
Responsible party
Sponsor
First posted
Jun 3, 2025
Start date
Jun 1, 2025
Primary completion
May 1, 2028 (estimated)
Completion
Nov 1, 2028 (estimated)
Last update
Jan 7, 2026

Study contacts

Jinglin Xu
Contact
xujl@forward-pharm.com
18964533182

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Breast Neoplasms→

Other studies from this sponsor

Forward Pharmaceuticals Co., Ltd.

Start the discussion