Niharika Bansal Mettu

Associate Professor of Medicine

Medicine, Medical Oncology

niharika.mettu@duke.edu

DUMC 3505, Durham, NC 27710

10 Bryan Searle Drive, Seeley G. Mudd Bldg, Room 433, Durham, NC 27710

More About This Person

At a Glance

Credentials
1. Education

Academic Experience

Expertise

Research
1. Selected Grants

Publications
1. Selected Publications

Artistic Works / Events

Teaching

Advising & Mentoring

Recognition

Professional Activities

Selected Grants

A Phase I/II, open-label, adaptive two-part trial to evaluate the safety, efficacy, optimal dose and pharmacokinetics of BNT326 as monotherapy and in combination with cancer immunotherapies in participants with advanced solid tumors.

Clinical TrialPrincipal Investigator · Awarded by BioNTech SE · 2025 - 2030

A Phase 1 Study of MOMA-341 as Monotherapy or Combination Therapy in Participants with Advanced or Metastatic Solid Tumors

Clinical TrialPrincipal Investigator · Awarded by MOMA Therapeutics, Inc. · 2025 - 2030

A Phase 1, Multicenter, Open-Label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of YL217 in Patients with Advanced Solid Tumors

Clinical TrialPrincipal Investigator · Awarded by MediLink Therapeutics (Suzhou) Co., Ltd. · 2025 - 2030

A Phase 1, Multicenter, Open-Label, Dose Escalation, Dose Expansion and Dose Confirmation Study of BHV-1530 in Adult Participants with Advanced or Metastatic Solid Tumors

Clinical TrialPrincipal Investigator · Awarded by Biohaven Pharmaceuticals · 2025 - 2030

Development and pilot testing of a behavioral intervention to improve pelvic dilator therapy use among cancer survivors who received pelvic radiation

ResearchAdvisor · Awarded by National Institutes of Health · 2025 - 2030

An open-label, Phase 1a/1b, dose escalation and dose expansion study investigating the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of PHST001 in adult patients with advanced relapsed and/or refractory solid tumors

Clinical TrialPrincipal Investigator · Awarded by Pheast Therapeutics, Inc. · 2025 - 2030

A PHASE 1 OPEN-LABEL STUDY OF PF-07934040 AS A SINGLE-AGENT AND IN COMBINATION WITH OTHER TARGETED AGENTS IN PARTICIPANTS WITH ADVANCED SOLID TUMORS HARBORING MUTATIONS IN THE KRAS GENE

Clinical TrialPrincipal Investigator · Awarded by Pfizer, Inc. · 2025 - 2030

A Phase 1/2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients with Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

Clinical TrialPrincipal Investigator · Awarded by PMV Pharmaceuticals, Inc. · 2025 - 2030

A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 193 in Combination With other Therapies in Subjects With Advanced Gastrointestinal, Biliary Tract, or Pancreatic Cancers With Homozygous MTAP-deletion Master

Clinical TrialPrincipal Investigator · Awarded by Amgen, Inc. · 2025 - 2030

RASolute 302: A Phase 3 Multicenter, Open-label, Randomized Study of RMC-6236 versus Investigator?s Choice of Standard of Care Therapy in Patients with Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)

Clinical TrialPrincipal Investigator · Awarded by Revolution Medicines, Inc · 2024 - 2029

A Phase 1/2, First-in-Human, Open-Label, Dose-Escalation Study of TAK-280 in Patients With Unresectable Locally Advanced or Metastatic Cancer

Clinical TrialPrincipal Investigator · Awarded by Takeda Development Center Americas, Inc · 2024 - 2029

A Phase 1 Study of NM32-2668 (Anti-ROR1/Anti-CD3/Anti-HSA Tri-Specific Antibody) in Adult Patients with Selected Advanced Solid Tumors

Clinical TrialPrincipal Investigator · Awarded by Numab Therapeutics AG · 2024 - 2029

A Phase 1, first-in-human, open-label, multicenter study of JZP898 as monotherapy and in combination with pembrolizumab in participants with advanced or metastatic solid tumors

Clinical TrialPrincipal Investigator · Awarded by Jazz Pharmaceuticals · 2024 - 2029

A Study of Disitamab Vedotin in Previously Treated Solid Tumors That Express HER2

Clinical TrialPrincipal Investigator · Awarded by Seagen, Inc · 2024 - 2029

A Phase 1/2 Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 193 in Combination With IDE397 in Subjects With Advanced MTAP-null Solid Tumors

Clinical TrialPrincipal Investigator · Awarded by Amgen, Inc. · 2024 - 2028

A Phase 1-2 dose-escalation and expansion study of ST316 in subjects with selected advanced unresectable and metastatic solid tumors

Clinical TrialPrincipal Investigator · Awarded by Sapience Therapeutics Inc. · 2023 - 2028

9-ING-41 With or Without Chemotherapy in Pancreatic Cancer (Actuate 1801)

Clinical TrialPrincipal Investigator · Awarded by Actuate Therapeutics · 2023 - 2028

A Phase 1, Open-Label, Multicenter Study of ADA-011 as Monotherapy and in Combination With Pembrolizumab for Subjects With Advanced Solid Tumors

Clinical TrialPrincipal Investigator · Awarded by Adanate, Inc. · 2023 - 2028

[MK-6482-016] Pembrolizumab plus lenvatinib and belzutifan for specified solid tumors

Clinical TrialPrincipal Investigator · Awarded by Merck Sharp & Dohme · 2021 - 2026

A Window-of-Opportunity Trial Using Neoadjuvant Hepatic Artery Chemotherapy for Patients With Localized Pancreas Cancer

ResearchCo Investigator · Awarded by Marc Lustgarten Pancreatic Cancer Foundation · 2023 - 2026

Circulating DKK1 Levels: Biomarker Assay Development

ResearchPrincipal Investigator · Awarded by Leap Therapeutics, Inc. · 2022 - 2026

Repare RP-3500-01

Clinical TrialPrincipal Investigator · Awarded by Repare Therapeutics · 2020 - 2025

A Phase 1b/2 Open-Label Study of the Efficacy and Safety of Etigilimab (MPH313) Administered in Combination with Nivolumab to Subjects with Locally Advanced or Metastatic Solid Tumors

Clinical TrialPrincipal Investigator · Awarded by Mereo BioPharma Group · 2021 - 2025

A Phase 1 Study of SY-5609, an Oral, Selective CDK7 Inhibitor, in Adult Patients With Select Advanced Solid Tumors

Clinical TrialPrincipal Investigator · Awarded by SYROS PHARMACEUTICALS · 2021 - 2025

A Two-Part, Phase II, Multi-center Study of the ERK Inhibitor Ulixertinib (BVD-523) for Patients with Advanced Malignancies Harboring MEK or Atypical BRAF Alterations

Clinical TrialPrincipal Investigator · Awarded by BioMed Valley Discoveries · 2020 - 2025

[NuTide:302] A Phase Ib/II open label study to assess the safety and pharmacokinetics of NUC-3373, a nucleotide analogue, given in combination with standard agents used in colorectal cancer treatment

Clinical TrialPrincipal Investigator · Awarded by NuCana plc · 2022 - 2025

Liquid Brachytherapy in a Porcine Model to Treat Pancreatic Cancer

ResearchUser Analyst · Awarded by North Carolina Biotechnology Center · 2024 - 2025

[RELATE] A Phase II Study of Retifanlimab (anti-PD-1), INCAGN02385 (anti-LAG-3), and INCAGN02390 (anti-TIM-3) as Second Line Treatment for Locally Advanced or Metastatic Squamous Cell Anal Cancer

Clinical TrialPrincipal Investigator · Awarded by Incyte Corporation · 2024 - 2025

A Phase I open label dose escalation safety and tolerability study of INCB054828 in subjects with advanced malignancies

Clinical TrialPrincipal Investigator · Awarded by Incyte Corporation · 2015 - 2025

A Phase 1b/2 Randomized Study of AVB-S6-500 plus Nab-paclitaxel and Gemcitabine in Patients with Locally Advanced, Recurrent, or Metastatic Pancreatic Adenocarcinoma

Clinical TrialPrincipal Investigator · Awarded by Aravive, Inc · 2021 - 2024

A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR

Clinical TrialPrincipal Investigator · Awarded by Incyte Corporation · 2019 - 2023

A Phase 1b/2 Study to Evaluate the Safety, Pharmacokinetics, and Clinical Activity of Oleclumab (MEDI9447) with or without Durvalumab in Combination with Chemotherapy in Subjects with Metastatic Pancreatic Ductal Adenocarcinoma

Clinical TrialPrincipal Investigator · Awarded by AstraZeneca LP · 2018 - 2023

AMV564-301

Clinical TrialPrincipal Investigator · Awarded by Amphivena Therapeutics · 2020 - 2023

A Randomized, Phase 3 Study of Eryaspase in Combination with Chemotherapy versus Chemotherapy Alone as Second-Line Treatment in Patients with Pancreatic Adenocarcinoma TRYbeCA-1 ¿ TRial of erYaspase in pancreatic CAncer

Clinical TrialPrincipal Investigator · Awarded by ERYTECH Pharma · 2019 - 2023

BACCI: A Phase II Randomized, Double-Blind, Placebo-Controlled Study of Capecitabine Bevacizumab plus Atezolizumab versus Capecitabine Bevacizumab plus Placebo in Patients with Refractory Metastatic Colorectal Cancer

Clinical TrialPrincipal Investigator · Awarded by Academic and Community Cancer Research United · 2017 - 2023

Single-cell cytokine profiling in metastatic colorectal cancer patients receiving immunotherapy

ResearchCollaborator · Awarded by Mario Family Foundation · 2022 - 2022

A Randomized, Open-Label, Phase 2 Study of Nivolumab in Combination with Ipilimumab or Nivolumab Monotherapy in Participants with Advanced or Metastatic Solid Tumors of High Tumor Mutational Burden (TMB-H)

Clinical TrialPrincipal Investigator · Awarded by Bristol-Myers Squibb Company · 2019 - 2022

A platform study exploring the safety tolerability effects on the tumor microenvironment and efficacy of Pembroliumab (MK-3475) + INCB combination

Clinical TrialPrincipal Investigator · Awarded by Incyte Corporation · 2016 - 2021

A Randomized Phase 3 Study of AM0010 in Combination with FOLFOX Compared with FOLFOX Alone as Second-line Therapy in Patients with Metastatic Pancreatic Cancer that has Progressed During or Following a First-Line Gemcitabine Containing Regimen

Clinical TrialPrincipal Investigator · Awarded by Eli Lilly and Company · 2017 - 2020

A Phase 1/2 study of exploring the safety tolerablility and efficacy of Epacadostat in combination with Durvalumab in subjects with selected advanced solid tumors.

Clinical TrialPrincipal Investigator · Awarded by Incyte Corporation · 2016 - 2020

A Phase 1a Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of OMP-313M32 Administered as a Single Agent to Subjects With Locally Advanced or Metastatic Solid Tumors

Clinical TrialPrincipal Investigator · Awarded by OncoMed Pharmaceuticals · 2017 - 2020

A Phase 1/2 study of the safety, tolorability and efficacy of INCB24360 administered in combination with Nivolumab in select advanced cancers.

Clinical TrialPrincipal Investigator · Awarded by Incyte Corporation · 2015 - 2020

A Pilot Study Investigating the Effect of Atezolizumab Monotherapy and Atezolizumab plus Cobimetinib on the Tumoral Immunoprofile in Liver Metastases from Colorectal Cancer

Clinical TrialPrincipal Investigator · Awarded by Genetech · 2018 - 2018

A Phase 2 proof of concept study of ACP-196 alone in combination with Pembrolizumab in subjects with advanced or metastatic pancreatic cancer.

Clinical TrialPrincipal Investigator · Awarded by Acerta Pharma · 2015 - 2018

A Multi center study of the Bruton's Tyrosine Kinase (BTK) inhibitor, Ibrutinib in combination with MEDI4736

Clinical TrialPrincipal Investigator · Awarded by Pharmacyclics, Inc. · 2015 - 2018

Preclinical and Human Correlative Studies of a Novel Bruton Tyronsine Kinase Inhibitor in Pancreatic Cancer

ResearchPrincipal Investigator · Awarded by Department of Defense · 2016 - 2017