Trial · NCT07897721
A Study to Learn About the Study Medicine Called PF-08165784 in People With PIK3CA-Mutated Advanced or Metastatic Solid Tumors
NCT07897721, Phase 1, Not yet recruiting, Pfizer
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Learn About the Study Medicine Called PF-08165784 in People With PIK3CA-Mutated Advanced or Metastatic Solid Tumors. Trials, record NCT07897721. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07897721
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Learn About the Study Medicine Called PF-08165784 in People With PIK3CA-Mutated Advanced or Metastatic Solid Tumors
- NCT number
- NCT07897721
- Status
- Not yet recruiting
- Phases
- Phase 1
- Enrollment
- 268 participants, estimated
- Lead sponsor
- Pfizer
- Conditions
- Advanced Breast Cancer, Advanced or Metastatic Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-), Metastatic Colorectal Adenocarcinoma
- Interventions
- PF-08165784, Fulvestrant, Atirmociclib, Cetuximab, Letrozole
- First posted
- 2026-10-27
- Last updated
- 2026-10-28
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1 (Dose Escalation): Number of participants with Dose-Limiting Toxicities (DLT) | Baseline up to 28 days | Any adverse events that are attributable to one, the other, or both study treatments, occurring in the DLT observation period are considered DLTs, excluding toxicities clearly due to underlying disease or extraneous causes. |
| Primary | Part 1 (Dose Escalation): Incidence of Adverse Events (AEs) | From start of treatment up to 30 days after last dose or start of new anticancer therapy, whichever occurred first | An adverse event (AE) was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it. |
| Primary | Part 1 (Dose Escalation): Number of participants with laboratory abnormalities | From start of treatment up to 30 days after last dose or start of new anticancer therapy, whichever occurred first | Number of participants with laboratory test abnormalities. |
| Primary | Part 2 (Dose Expansion): Objective Response Rate (ORR) | Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion (approximately 2 years) | ORR defined as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1). |
| Secondary | Part 1: Objective Response Rate (ORR) as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) | Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion (approximately 2 years) | ORR is defined as the percentage of participants in the analysis population having a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST v1.1. |
| Secondary | Part 1 & Part 2: Disease Control Rate (DCR) as per RECIST v1.1 | Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion (approximately 2 years) | DCR is defined as the proportion of participants with CR or PR with confirmation, or Stable Disease (SD) per RECIST version 1.1. |
| Secondary | Part 1 & Part 2: Clinical Benefit Rate (CBR) as per RECIST v1.1 | Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion (approximately 2 years) | CBR is defined as the percentage of participants with a best overall response of CR or PR at any time before Progressive Disease (PD), or non-CR/non-PD or SD for at least 24 weeks from start date of treatment and prior to PD, relative to the appropriate analysis set. |
| Secondary | Part 1 & Part 2: Duration of Response (DOR) as per RECIST v1.1 | Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion (approximately 2 years) | DOR is defined as the time from first documentation of CR or PR to date of first documentation of PD or death due to any cause. |
| Secondary | Part 1 & Part 2: Progression-Free Survival (PFS) as per RECIST v1.1 | Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion (approximately 2 years) | PFS is defined as time from start date of treatment to the date of first documentation of PD or death due to any cause. |
| Secondary | Part 1 & Part 2: Time to Response (TTR) as per RECIST v1.1 | Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion (approximately 2 years) | TTR is defined as the time from start date of treatment to first documentation of CR or PR. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 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/NCT07897721
GET https://conductscience.org/api/trials/v1/NCT07897721/registered