Trial · NCT07905001
A Phase 1/1b Study of PRT13722 in Participants With Advanced HR+/HER2- Breast Cancer
NCT07905001, Phase 1, Recruiting, Prelude Therapeutics Incorporated
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase 1/1b Study of PRT13722 in Participants With Advanced HR+/HER2- Breast Cancer. Trials, record NCT07905001. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07905001
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 1/1b Study of PRT13722 in Participants With Advanced HR+/HER2- Breast Cancer
- NCT number
- NCT07905001
- Status
- Recruiting
- Phases
- Phase 1
- Enrollment
- 242 participants, estimated
- Lead sponsor
- Prelude Therapeutics Incorporated
- Conditions
- Breast Cancer, Hormone-receptor-positive Breast Cancer, HER2-negative Breast Cancer, HR-positive Breast Cancer, HR+/HER2- Breast Cancer, Locally Advanced Breast Cancer, Metastatic Breast Cancer
- Interventions
- PRT13722, Fulvestrant, Abemaciclib, Imlunestrant
- First posted
- 2026-10-29
- Last updated
- 2026-11-12
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose limiting toxicity of PRT13722 (Parts 1A and 2) | Through cycle 1 (28 days) | Incidence of dose limiting toxicities, defined according to protocol-specified criteria |
| Primary | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of PRT13722 as monotherapy and in combination (Parts 1A and 2) | Through study completion, an average of 2 years | Safety and tolerability assessed by the number of participants with treatment-emergent adverse events, serious adverse events, adverse events leading to dose modification, treatment interruption, or treatment discontinuation, and clinically significant laboratory abnormalities. Adverse events and selected laboratory abnormalities will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 6.0 |
| Primary | Preliminary Antitumor Activity: Objective Response Rate (Parts 1B and 3) | Through study completion, an average of 2 years | Proportion of patients with best overall response of either complete response or partial response, as assessed by the investigator per RECIST v1.1 |
| Secondary | Preliminary Antitumor Activity: Objective Response Rate (Parts 1A and 2) | Through study completion, an average of 2 years | Proportion of patients with best overall response of either complete response or partial response, as assessed by the investigator per RECIST v1.1 |
| Secondary | Duration of Response | Through study completion, an average of 2 years | Time from first documented response to disease progression as assessed by the investigator per RECIST v1.1, or death, whichever comes first. |
| Secondary | Clinical Benefit Response | Through study completion, an average of 2 years | Proportion of patients with a best overall response of complete response, partial response, or durable stable disease (24 weeks or longer), as assessed by the investigator per RECIST v1.1 |
| Secondary | Progression-Free Survival | Through study completion, an average of 2 years | Time from the date of first dose of investigational product to the date of first documented disease progression, as assessed by the investigator per RECIST v1.1, or death due to any cause |
| Secondary | Overall Survival | Through study completion, an average of 2 years | Time from the date of first dose of investigational product to death due to any cause |
| Secondary | Incidence of Treatment-Emergent Adverse Events [Safety and tolerability] of PRT13722 as Monotherapy and in Combination (Parts 1B and 3) | Through study completion, an average of 2 years | Safety and tolerability will be evaluated by incidence of adverse events leading to dose modifications, treatment interruptions, treatment discontinuations, and clinically significant laboratory abnormalities graded according to NCI CTCAE, Version 6.0 |
| Secondary | Maximum Observed Plasma Concentration (Cmax) | Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 (each cycle is 28 days) | Maximum observed plasma concentration will be calculated using non-compartmental analysis |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 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/NCT07905001
GET https://conductscience.org/api/trials/v1/NCT07905001/registered