Trial · NCT07002177
A Phase Ib/II Study to Evaluate Multiple Combination Therapies of FWD1802 in Patients With ER+/HER2- BC
NCT07002177, Phase 1, Phase 2, Recruiting, Forward Pharmaceuticals Co., Ltd.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase Ib/II Study to Evaluate Multiple Combination Therapies of FWD1802 in Patients With ER+/HER2- BC. Trials, record NCT07002177. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07002177
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase Ib/II Study to Evaluate Multiple Combination Therapies of FWD1802 in Patients With ER+/HER2- BC
- NCT number
- NCT07002177
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 196 participants, estimated
- Lead sponsor
- Forward Pharmaceuticals Co., Ltd.
- Conditions
- Metastatic Breast Cancer, Breast Cancer Stage I, Breast Cancer Stage II, Locally Advanced Breast Cancer (LABC), ER+ Breast Cancer
- Interventions
- FWD1802, Palbociclib 125mg, Ribociclib 200Mg Oral Tablet, Abemaciclib 150 MG, Everolimus 10 mg
- First posted
- 2025-06-03
- Last updated
- 2026-01-07
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase Ib- Dose-Limiting Toxicity (DLT). | Approximately 1.5 years | |
| Primary | Phase Ib- Maximum Tolerated Dose (MTD). | Approximately 1.5 years | |
| Primary | Phase Ib- Recommended Phase II Dose (RP2D). | Approximately 1.5 years | |
| Primary | Incidence of Treatment-Emergent Adverse Events (TEAEs) | 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). |
| Primary | Severity Grading of Adverse Events | 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). |
| Primary | Clinically Significant Abnormalities in 12-Lead ECG Parameters | 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. |
| Primary | Vital Sign Abnormalities | 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). |
| Primary | Serious Adverse Events (SAEs) Incidence | Approximately 2 years | |
| Primary | Phase II- Investigator-assessed Objective Response Rate (ORR) based on RECIST v1.1. | Approximately 2 years | |
| Secondary | Phase Ib- PK Assessment-Tmax | Approximately 1.5 years | Time to Cmax (Tmax). |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07002177
GET https://conductscience.org/api/trials/v1/NCT07002177/registered?page=2