Metastatic Breast CancerPhase 1/2NCT07002177
A Phase Ib/II Study to Evaluate Multiple Combination Therapies of FWD1802 in Patients With ER+/HER2- BC
A Phase 1/2 study testing FWD1802, Palbociclib 125mg and Ribociclib 200Mg Oral Tablet in people with Metastatic Breast Cancer and Breast Cancer Stage I, run by Forward Pharmaceuticals Co., Ltd. at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Metastatic Breast Cancer, Breast Cancer Stage I, Breast Cancer Stage II
- What is being tested?
- FWD1802, Palbociclib 125mg and Ribociclib 200Mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 1 Nov 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Progression during/after, intolerance to, ineligibility for, or refusal of standard therapy
- Endocrine therapy history:
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- 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).
- ≤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.
- 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.
Who cannot join
- 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).
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- Subjects will be excluded if they meet any of the following:
- 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
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center, Shanghai
Shanghai
About this study
Official title: An Open-label, Multicenter, Phase Ib/II Clinical Study to Evaluate the Safety and Efficacy of Multiple Combination Therapies With FWD1802 in Subjects With ER-positive/HER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer
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
- Conditions
- Metastatic Breast Cancer, Breast Cancer Stage I, Breast Cancer Stage II, Locally Advanced Breast Cancer (LABC), ER+ Breast Cancer
- Being tested
- FWD1802, Palbociclib 125mg, Ribociclib 200Mg Oral Tablet, Abemaciclib 150 MG, Everolimus 10 mg
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FWD1802Drug
orally QD with 28 days each cycle, treatment till disease progression or intolerable toxicity or withdraw for other reasons
Palbociclib 125mgDrug
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 TabletDrug
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 MGDrug
Dose: 150 mg Route: Orally Frequency: BID Schedule: Everyday
Everolimus 10 mgDrug
Dose: 10 mg Route: Orally Frequency: QD Schedule: Everyday
| Study group | Role | What they receive |
|---|---|---|
| FWD1802 in combination with Palbociclib (CDK4/6 inhibitor) with or without LHRH agonist； | Experimental | Not described Receives: Drug: FWD1802; Drug: Palbociclib 125mg |
| FWD1802 in combination with Ribociclib (CDK4/6 inhibitor) with or without LHRH agonist | Experimental | Not described Receives: Drug: FWD1802; Drug: Ribociclib 200Mg Oral Tablet |
| FWD1802 in combination with Abemaciclib (CDK4/6 inhibitor) with or without LHRH agonist | Experimental | Not described Receives: Drug: FWD1802; Drug: Abemaciclib 150 MG |
| FWD1802 in combination with Everolimus (mTOR inhibitor) with or without LHRH agonist | Experimental | Not described Receives: Drug: FWD1802; Drug: Everolimus 10 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase Ib- Dose-Limiting Toxicity (DLT).
Measured: Approximately 1.5 years
Phase Ib- Maximum Tolerated Dose (MTD).
Measured: Approximately 1.5 years
Phase Ib- Recommended Phase II Dose (RP2D).
Measured: Approximately 1.5 years
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).
Measured: Approximately 2 years
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).
Measured: Approximately 2 years
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.
Measured: Approximately 2 years
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).
Measured: Approximately 2 years
Serious Adverse Events (SAEs) Incidence
Measured: Approximately 2 years
Phase II- Investigator-assessed Objective Response Rate (ORR) based on RECIST v1.1.
Measured: Approximately 2 years
Secondary outcomes (12)
Phase Ib- PK Assessment-Tmax
Time to Cmax (Tmax).
Measured: Approximately 1.5 years
Phase Ib- PK Assessment-Cmax
Maximum plasma concentration (Cmax)
Measured: Approximately 1.5 years
Phase Ib- PK Assessment-AUC0-t
Area under the concentration versus time curve from time 0 to the last measurable concentration (AUC0-t)
Measured: Approximately 1.5 years
Phase Ib- PK Assessment-AUC0-inf
The area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-inf)
Measured: Approximately 1.5 years
Phase Ib- PK Assessment-t1/2
elimination half-life time (t1/2)
Measured: Approximately 1.5 years
Efficacy Assessment-ORR
Tumor response assessments by the corresponding criteria by RECIST v1.1 to assess Objective response rate (ORR)
Measured: Approximately 2 years
Efficacy Assessment-CBR
Clinical benefit rate (CBR)
Measured: Approximately 2 years
Efficacy Assessment-DOR
Duration of response (DoR）
Measured: Approximately 2 years
Efficacy Assessment-DCR
Disease control rate (DCR)
Measured: Approximately 1.5 years
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.
Measured: Approximately 2 years
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.
Measured: Approximately 2 years
Pharmacokinetic (PK) Parameters:Plasma Concentration at Each Sampling Time Point.
Measured: Approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start1 Jun 2025
- Primary completion1 May 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Forward Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07002177
- Sponsor's protocol ID
- FWD1802-002C
- Status last verified
- Jan 2026
- First submitted
- 14 May 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter, Phase Ib/II Clinical Study to Evaluate the Safety and Efficacy of Multiple Combination Therapies With FWD1802 in Subjects With ER-positive/HER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT07002177
- Acronym / sponsor ID
- FWD1802-002C
- Conditions
- Metastatic Breast Cancer, Breast Cancer Stage I, Breast Cancer Stage II, Locally Advanced Breast Cancer (LABC), ER+ Breast Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Forward Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 3 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| FWD1802 in combination with Palbociclib (CDK4/6 inhibitor) with or without LHRH agonist； | Experimental | Drug: FWD1802, Drug: Palbociclib 125mg |
| FWD1802 in combination with Ribociclib (CDK4/6 inhibitor) with or without LHRH agonist | Experimental | Drug: FWD1802, Drug: Ribociclib 200Mg Oral Tablet |
| FWD1802 in combination with Abemaciclib (CDK4/6 inhibitor) with or without LHRH agonist | Experimental | Drug: FWD1802, Drug: Abemaciclib 150 MG |
| FWD1802 in combination with Everolimus (mTOR inhibitor) with or without LHRH agonist | Experimental | Drug: FWD1802, Drug: Everolimus 10 mg |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- 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).
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FWD1802orally QD with 28 days each cycle, treatment till disease progression or intolerable toxicity or withdraw for other reasons | Drug | FWD1802 in combination with Abemaciclib (CDK4/6 inhibitor) with or without LHRH agonist, FWD1802 in combination with Everolimus (mTOR inhibitor) with or without LHRH agonist, FWD1802 in combination with Palbociclib (CDK4/6 inhibitor) with or without LHRH agonist；, FWD1802 in combination with Ribociclib (CDK4/6 inhibitor) with or without LHRH agonist |
| Palbociclib 125mgDose: 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 | Drug | FWD1802 in combination with Palbociclib (CDK4/6 inhibitor) with or without LHRH agonist； |
| Ribociclib 200Mg Oral TabletDose: 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 | Drug | FWD1802 in combination with Ribociclib (CDK4/6 inhibitor) with or without LHRH agonist |
| Abemaciclib 150 MGDose: 150 mg Route: Orally Frequency: BID Schedule: Everyday | Drug | FWD1802 in combination with Abemaciclib (CDK4/6 inhibitor) with or without LHRH agonist |
| Everolimus 10 mgDose: 10 mg Route: Orally Frequency: QD Schedule: Everyday | Drug | FWD1802 in combination with Everolimus (mTOR inhibitor) with or without LHRH agonist |
Primary outcome
Phase Ib- Dose-Limiting Toxicity (DLT).
Time frame: Approximately 1.5 years
Phase Ib- Maximum Tolerated Dose (MTD).
Time frame: Approximately 1.5 years
Phase Ib- Recommended Phase II Dose (RP2D).
Time frame: Approximately 1.5 years
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Approximately 2 years
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).
Severity Grading of Adverse Events
Time frame: Approximately 2 years
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).
Clinically Significant Abnormalities in 12-Lead ECG Parameters
Time frame: Approximately 2 years
Number of participants with clinically significant changes in electrocardiogram parameters from baseline. Assessed parameters: QTc interval, PR interval, QRS duration, heart rate.
Vital Sign Abnormalities
Time frame: Approximately 2 years
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).
Serious Adverse Events (SAEs) Incidence
Time frame: Approximately 2 years
Phase II- Investigator-assessed Objective Response Rate (ORR) based on RECIST v1.1.
Time frame: Approximately 2 years
12 secondary outcomes
Phase Ib- PK Assessment-Tmax
Time frame: Approximately 1.5 years
Phase Ib- PK Assessment-Cmax
Time frame: Approximately 1.5 years
Phase Ib- PK Assessment-AUC0-t
Time frame: Approximately 1.5 years
Phase Ib- PK Assessment-AUC0-inf
Time frame: Approximately 1.5 years
Phase Ib- PK Assessment-t1/2
Time frame: Approximately 1.5 years
Efficacy Assessment-ORR
Time frame: Approximately 2 years
Efficacy Assessment-CBR
Time frame: Approximately 2 years
Efficacy Assessment-DOR
Time frame: Approximately 2 years
Efficacy Assessment-DCR
Time frame: Approximately 1.5 years
Efficacy Assessment-PFS
Time frame: Approximately 2 years
Efficacy Assessment-OS
Time frame: Approximately 2 years
Pharmacokinetic (PK) Parameters:Plasma Concentration at Each Sampling Time Point.
Time frame: Approximately 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing FWD1802, Palbociclib 125mg and Ribociclib 200Mg Oral Tablet in people with Metastatic Breast Cancer and Breast Cancer Stage I, run by Forward Pharmaceuticals Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jinglin Xu (18964533182, xujl@forward-pharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase Ib- Dose-Limiting Toxicity (DLT). (time frame: Approximately 1.5 years). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.