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NCT07020117RECRUITINGanonymous

NECTINIUM-2: A Phase 1b, 2 Part, Multicenter, Single Arm, Open Label Study to Evaluate the Safety and Efficacy of a Nectin-4 Radiopharmaceutical ([225Ac]Ac-AKY-1189) in Patients With Previously Treated Locally Advanced or Metastatic Solid Tumors

Sponsor

Source record

Aktis Oncology, Inc.

Phase

Source record

PHASE1

Modality

AI-normalized

small molecule

Target

AI-normalized

[225Ac]Ac-AKY-1189 (therapeutic), [64Cu]Cu-AKY-1189 (imaging)

Indication / condition

AI-normalized

Urothelial Carcinoma Bladder

Intervention

Source record

[225Ac]Ac-AKY-1189 (therapeutic), [64Cu]Cu-AKY-1189 (imaging)

Source & freshness

Source record

NCT ID

NCT07020117

Original source

ClinicalTrials.gov

Source last updated

Apr 21, 2026

Ingested at

Jun 11, 2026

Internal sync

Jun 11, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

Open original registry record
View original source fields

NCT ID

NCT07020117

Title

NECTINIUM-2: A Phase 1b, 2 Part, Multicenter, Single Arm, Open Label Study to Evaluate the Safety and Efficacy of a Nectin-4 Radiopharmaceutical ([225Ac]Ac-AKY-1189) in Patients With Previously Treated Locally Advanced or Metastatic Solid Tumors

Sponsor

Aktis Oncology, Inc.

Status

RECRUITING

Phase

PHASE1

Condition raw

Urothelial Carcinoma Bladder, Triple Negative Breast Cancer (TNBC), Hormone Receptor Positive Breast Adenocarcinoma, Non Small Cell Lung Cancer, Cervical Adenocarcinoma, Colorectal Adenocarcinoma, Head and Neck Cancer

Condition normalized

Urothelial Carcinoma Bladder, Triple Negative Breast Cancer (TNBC), Hormone Receptor Positive Breast Adenocarcinoma, Non Small Cell Lung Cancer, Cervical Adenocarcinoma, Colorectal Adenocarcinoma, Head and Neck Cancer

Modality raw

small molecule

Modality normalized

small molecule

Target raw

[225Ac]Ac-AKY-1189 (therapeutic), [64Cu]Cu-AKY-1189 (imaging)

Target normalized

[225Ac]Ac-AKY-1189 (therapeutic), [64Cu]Cu-AKY-1189 (imaging)

Interventions

[225Ac]Ac-AKY-1189 (therapeutic), [64Cu]Cu-AKY-1189 (imaging)

Public preview

Source record

This is a first-in-human Phase 1b, 2-part, multicenter open-label clinical study to evaluate safety and efficacy of a Nectin-4 radiopharmaceutical (\[225Ac\]Ac-AKY-1189) in patients with locally advanced or metastatic solid tumors and to establish the maximum tolerated dose (MTD) or maximum administered dose (MAD) and the recommended Phase 2 dose.

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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TrialSignal

Clinical trial intelligence report

NECTINIUM-2: A Phase 1b, 2 Part, Multicenter, Single Arm, Open Label Study to Evaluate the Safety and Efficacy of a Nectin-4 Radiopharmaceutical ([225Ac]Ac-AKY-1189) in Patients With Previously Treated Locally Advanced or Metastatic Solid Tumors

Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.

Generated

Jun 13, 2026

NCT ID

NCT07020117

Status

RECRUITING

Phase

PHASE1

Sponsor

Aktis Oncology, Inc.

Executive brief

Investment-Ready Snapshot

This is a first-in-human Phase 1b, 2-part, multicenter open-label clinical study to evaluate safety and efficacy of a Nectin-4 radiopharmaceutical (\[225Ac\]Ac-AKY-1189) in patients with locally advanced or metastatic solid tumors and to establish the maximum tolerated dose (MTD) or maximum administered dose (MAD) and the recommended Phase 2 dose.

Source & freshness

Provenance

SourceClinicalTrials.gov
Source updatedApr 21, 2026
Internal syncJun 11, 2026
Model versiontrialsignal-ai-v1

https://clinicaltrials.gov/study/NCT07020117

Indication

Urothelial Carcinoma Bladder

Modality

small molecule

Target

[225Ac]Ac-AKY-1189 (therapeutic), [64Cu]Cu-AKY-1189 (imaging)

Intervention

[225Ac]Ac-AKY-1189 (therapeutic), [64Cu]Cu-AKY-1189 (imaging)

Source record

Protocol Description

Detailed source ingestion pending.

Source record

Outcome Measures

Detailed source ingestion pending.

Source record

Eligibility

Detailed source ingestion pending.

AI analysis

Known Results And Readout Context

Detailed source ingestion pending.

IP intelligence

Patent And IP Landscape

Detailed source ingestion pending.

Source record

Contacts

Detailed source ingestion pending.