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NCT06586957RECRUITINGanonymous

A Phase 1, First-in-human, Open-label Study to Evaluate the Safety, Tolerability, PK, and Preliminary Anti-tumor Activity of the Novel Oral CDK2 Degrader NKT3964 in Adults With Advanced/Metastatic Solid Tumors

Sponsor

Source record

NiKang Therapeutics, Inc.

Phase

Source record

Phase 1

Modality

AI-normalized

small molecule

Target

AI-normalized

CDK2 (Cyclin-dependent kinase 2)

Indication / condition

AI-normalized

Solid Tumor

Intervention

Source record

NKT3964

Source & freshness

Source record

NCT ID

NCT06586957

Original source

ClinicalTrials.gov

Source last updated

Apr 21, 2026

Ingested at

Jun 13, 2026

Internal sync

Jun 13, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

Open original registry record
View original source fields

NCT ID

NCT06586957

Title

A Phase 1, First-in-human, Open-label Study to Evaluate the Safety, Tolerability, PK, and Preliminary Anti-tumor Activity of the Novel Oral CDK2 Degrader NKT3964 in Adults With Advanced/Metastatic Solid Tumors

Sponsor

NiKang Therapeutics, Inc.

Status

RECRUITING

Phase

Phase 1

Condition raw

Solid Tumor, Advanced Solid Tumor, Solid Tumor, Adult, Metastatic Tumor, Ovarian Cancer, Ovarian Neoplasms, Ovarian Carcinoma, Metastatic Ovarian Carcinoma, Endometrial Neoplasms, Endometrial Diseases, Metastatic Endometrial Cancer, Triple Negative Breast Cancer, Metastatic Endometrial Carcinoma, Advanced Endometrial Carcinoma, Advanced Ovarian Carcinoma, Gastric Cancer, Advanced Gastric Carcinoma, Metastatic Gastric Cancer, Metastatic Gastric Carcinoma, Small Cell Lung Cancer, Small Cell Lung Carcinoma, Triple Negative Breast Neoplasms, Platinum-resistant Ovarian Cancer, Platinum-refractory Ovarian Carcinoma, CCNE1 Amplification, Hormone Receptor Negative Breast Carcinoma, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, Progesterone-receptor-positive Breast Cancer

Condition normalized

Solid Tumor, Advanced Solid Tumor, Solid Tumor, Adult, Metastatic Tumor, Ovarian Cancer, Ovarian Neoplasms, Ovarian Carcinoma, Metastatic Ovarian Carcinoma, Endometrial Neoplasms, Endometrial Diseases, Metastatic Endometrial Cancer, Triple Negative Breast Cancer, Metastatic Endometrial Carcinoma, Advanced Endometrial Carcinoma, Advanced Ovarian Carcinoma, Gastric Cancer, Advanced Gastric Carcinoma, Metastatic Gastric Cancer, Metastatic Gastric Carcinoma, Small Cell Lung Cancer, Small Cell Lung Carcinoma, Triple Negative Breast Neoplasms, Platinum-resistant Ovarian Cancer, Platinum-refractory Ovarian Carcinoma, CCNE1 Amplification, Hormone Receptor Negative Breast Carcinoma, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, Progesterone-receptor-positive Breast Cancer

Modality raw

small molecule

Modality normalized

small molecule

Target raw

CDK2 (Cyclin-dependent kinase 2)

Target normalized

CDK2 (Cyclin-dependent kinase 2)

Interventions

NKT3964

Public preview

Source record

NKT3964, a novel oral CDK2 degrader, is currently undergoing a Phase 1 clinical trial sponsored by NiKang Therapeutics, Inc. The trial aims to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity in adults with advanced or metastatic solid tumors. The targeted patient population includes those with specific tumor types exhibiting CCNE1 amplification, which may provide a niche market opportunity. The competitive landscape includes existing CDK inhibitors and emerging protein degraders, indicating a need for differentiation in efficacy and safety profiles. Successful outcomes could position NKT3964 favorably in the oncology market, particularly for patients with limited treatment options. Diligence should focus on regulatory pathways, potential partnerships, and the evolving landscape of targeted therapies.

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

A Phase 1, First-in-human, Open-label Study to Evaluate the Safety, Tolerability, PK, and Preliminary Anti-tumor Activity of the Novel Oral CDK2 Degrader NKT3964 in Adults With Advanced/Metastatic Solid Tumors

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

Generated

Jun 16, 2026

NCT ID

NCT06586957

Status

RECRUITING

Phase

Phase 1

Sponsor

NiKang Therapeutics, Inc.

Executive brief

Investment-Ready Snapshot

NKT3964, a novel oral CDK2 degrader, is currently undergoing a Phase 1 clinical trial sponsored by NiKang Therapeutics, Inc. The trial aims to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity in adults with advanced or metastatic solid tumors. The targeted patient population includes those with specific tumor types exhibiting CCNE1 amplification, which may provide a niche market opportunity. The competitive landscape includes existing CDK inhibitors and emerging protein degraders, indicating a need for differentiation in efficacy and safety profiles. Successful outcomes could position NKT3964 favorably in the oncology market, particularly for patients with limited treatment options. Diligence should focus on regulatory pathways, potential partnerships, and the evolving landscape of targeted therapies.

Source & freshness

Provenance

SourceClinicalTrials.gov
Source updatedApr 21, 2026
Internal syncJun 13, 2026
Model versiontrialsignal-ai-v1

https://clinicaltrials.gov/study/NCT06586957

Indication

Solid Tumor

Modality

small molecule

Target

CDK2 (Cyclin-dependent kinase 2)

Intervention

NKT3964

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.