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NCT06125522ACTIVE_NOT_RECRUITINGanonymous

TACTIVE-U: AN INTERVENTIONAL SAFETY AND EFFICACY PHASE 1B/2, OPEN-LABEL UMBRELLA STUDY TO INVESTIGATE TOLERABILITY, PK, AND ANTITUMOR ACTIVITY OF VEPDEGESTRANT (ARV-471/PF-07850327), AN ORAL PROTEOLYSIS TARGETING CHIMERA, IN COMBINATION WITH OTHER ANTICANCER TREATMENTS IN PARTICIPANTS AGED 18 AND OLDER WITH ER+ ADVANCED OR METASTATIC BREAST CANCER, SUB-STUDY C (ARV-471 IN COMBINATION WITH SAMURACICLIB)

Sponsor

Source record

Pfizer

Phase

Source record

Phase 1b/2

Modality

AI-normalized

small molecule

Target

AI-normalized

Estrogen Receptor (ER) and CDK4/6 pathway

Indication / condition

AI-normalized

Breast Cancer

Intervention

Source record

vepdegestrant, Samuraciclib

Source & freshness

Source record

NCT ID

NCT06125522

Original source

ClinicalTrials.gov

Source last updated

May 06, 2026

Ingested at

Jun 18, 2026

Internal sync

Jun 18, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

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NCT ID

NCT06125522

Title

TACTIVE-U: AN INTERVENTIONAL SAFETY AND EFFICACY PHASE 1B/2, OPEN-LABEL UMBRELLA STUDY TO INVESTIGATE TOLERABILITY, PK, AND ANTITUMOR ACTIVITY OF VEPDEGESTRANT (ARV-471/PF-07850327), AN ORAL PROTEOLYSIS TARGETING CHIMERA, IN COMBINATION WITH OTHER ANTICANCER TREATMENTS IN PARTICIPANTS AGED 18 AND OLDER WITH ER+ ADVANCED OR METASTATIC BREAST CANCER, SUB-STUDY C (ARV-471 IN COMBINATION WITH SAMURACICLIB)

Sponsor

Pfizer

Status

ACTIVE_NOT_RECRUITING

Phase

Phase 1b/2

Condition raw

Breast Cancer

Condition normalized

Breast Cancer

Modality raw

small molecule

Modality normalized

small molecule

Target raw

Estrogen Receptor (ER) and CDK4/6 pathway

Target normalized

Estrogen Receptor (ER) and CDK4/6 pathway

Interventions

vepdegestrant, Samuraciclib

Public preview

Source record

The TACTIVE-U study, sponsored by Pfizer, is investigating the combination of vepdegestrant (ARV-471) and samuraciclib in patients with ER+ advanced or metastatic breast cancer. Given the significant unmet need in this patient population, particularly those who have become resistant to prior therapies, successful outcomes could position this combination as a competitive treatment option in the growing breast cancer therapeutics market. The study's design allows for flexibility in evaluating multiple combinations, potentially enhancing Pfizer's portfolio in oncology. The collaboration with Arvinas and Carrick Therapeutics may also provide strategic advantages in leveraging complementary expertise and resources. As the study is currently active but not recruiting, ongoing monitoring of patient enrollment and interim results will be critical for assessing market potential and competitive positioning.

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

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