A Study of NDI 1150-101 in Patients With Solid Tumors
This study is to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) and to investigate the safety, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of NDI-101150 given as monotherapy or in combination with pembrolizumab in adult patients with advanced solid tumors.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Nov 25, 2024 · Source: ClinicalTrials.gov
The study is underway but is not accepting new participants.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- Nimbus Saturn, Inc.
- Interventions being studied
- Drug: NDI-101150; Drug: Pembrolizumab
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Key
- Life expectancy of ≥ 12 weeks
- Measurable or non-measurable disease for Dose Escalation; measurable disease using RECIST v1.1 is required for Dose Expansion
- Recovered from prior therapy to Grade ≤ 1 or return to baseline status (except for alopecia)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Patients with adequate bone marrow, kidney and liver function
- Last dose of previous anticancer therapy ≥ 4 weeks prior to first dose of NDI-101150; includes prior anti-PD-1 or anti-PD-L1 therapy, other anticancer therapy, radiotherapy, or surgical intervention
- For Dose Escalation Phase Only (Dose Escalation, Monotherapy and Combination Therapy): Histologically or cytologically confirmed advanced or metastatic solid tumors for whom no standard therapies are available or refractory to standard therapy
- For Dose Expansion Phase (Dose Expansion, Monotherapy and Combination Therapy): Willing to consent to required tumor biopsy(ies). Histologically or cytologically confirmed advanced or metastatic G/GEJ, NSCLC or RCC for which no standard therapy is available or are refractory to standard therapy Key
- Previous solid organ or hematopoietic cell transplant
- Central nervous system (CNS) malignant disease not previously treated, active leptomeningeal disease, uncontrolled symptomatic CNS involvement, or CNS malignant disease requiring steroid or other therapeutic intervention
- Prior anticancer therapy within 2-6 weeks of trial start (depending on nature of therapy).
- Clinically significant cardiovascular disease
- History of severe hypersensitivity reaction to treatment with monoclonal antibody(ies) (for combination therapy cohorts only)
- History of interstitial lung disease, idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of history of pneumonitis on chest computed tomography scan in the last 6 months
- Known additional malignancy that is active and/or in progression requiring treatment
- Unstable or severe uncontrolled medical condition (e.g., unstable cardiac function, unstable pulmonary condition, uncontrolled diabetes, thromboembolic event within the past 3 months) or any important medical or psychiatric illness or abnormal laboratory finding
- Unable to discontinue medications that are strong inducers or inhibitors of CYP3A4 and/or CYP2C8
- History of severe irAE that led to permanent discontinuation of prior immunotherapy
- History of recent Grade \>/= 3 irAE or any Grade 4 life-threatening irAE, neurologic or ocular AE of any grade while receiving prior immunotherapy NOTE: Other protocol defined Inclusion and
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Honor Health Research InstituteScottsdale, Arizona
- Yale Cancer CenterNew Haven, Connecticut
- Georgetown UniversityWashington D.C., District of Columbia
- Ocala Oncology CenterOcala, Florida
- Norton Cancer InstituteLouisville, Kentucky
- University of Maryland Greenebaum Comprehensive Cancer CenterBaltimore, Maryland
- Henry Ford CancerDetroit, Michigan
- HealthPartners Cancer Research CenterSaint Paul, Minnesota
- Washington UniversitySt Louis, Missouri
- Hackensack UniversityHackensack, New Jersey
- Columbia University Irving Medical CenterNew York, New York
- Stephenson Cancer CenterOklahoma City, Oklahoma
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 25, 2024. Always confirm current availability with the study team.