A Study of NDI 1150-101 in Patients With Solid Tumors

NCT05128487 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 1150-101
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 19

Brief Summary

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.

Conditions

Solid Tumor; Renal Cell Carcinoma (Kidney Cancer); Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma; Non-Small Cell Lung Cancer

Keywords

Dose escalation phase; Dose expansion phase; Hematopoietic progenitor kinase 1; NDI-101150; First-in-human; Maximum tolerated dose; Recommended Phase 2 dose; Renal Cell Carcinoma; Gastric and gastroesophageal junction cancer; Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Part 1: Frequency of dose-limiting toxicities (DLTs)

  Cycle 1 (28 days)

• Part 2: Objective response rate (ORR)

  Up to approximately 34 months

Secondary Outcomes (10)

• Part 1 and Part 2: Number of patients with adverse events (AEs) and Serious adverse events (SAEs)

  From Screening (Day -28 to Day -1) until safety follow-up (>30 days after last dose) [Assessed up to 37 months]

• Part 1 and Part 2: Maximum plasma concentration (Cmax) of NDI-101150

  Cycle 1 Day 1, Cycle 2 Day 1, Cycle 1 Day 2, Cycle 2 Day 2 (Monotherapy); at EOT (end-of-treatment)/ET (early termination) [Cycle length is 28 days for monotherapy and 21 days for combination therapy] (Up to 37 months)

• Part 1 and Part 2: Time to maximum plasma concentration (tmax) of NDI-101150

  Cycle 1 Day 1, Cycle 2 Day 1, Cycle 1 Day 2, Cycle 2 Day 2 (Monotherapy); at EOT (end-of-treatment)/ET (early termination) [Cycle length is 28 days for monotherapy and 21 days for combination therapy] (Up to 37 months)

• Part 1 and Part 2: Area under the concentration-time curve from time zero to the last observable concentration (AUC0-t) of NDI-101150

  Cycle 1 Day 1, Cycle 2 Day 1, Cycle 1 Day 2, Cycle 2 Day 2 (Monotherapy); at EOT (end-of-treatment)/ET (early termination) [Cycle length is 28 days for monotherapy and 21 days for combination therapy] (Up to 37 months)

• Part 1 and Part 2: Area under the concentration-time curve extrapolated to infinity (AUC0-∞) of NDI-101150

  Cycle 1 Day 1, Cycle 2 Day 1, Cycle 1 Day 2, Cycle 2 Day 2 (Monotherapy); at EOT (end-of-treatment)/ET (early termination) [Cycle length is 28 days for monotherapy and 21 days for combination therapy] (Up to 37 months)

Study Arms (2)

NDI-101150 (Monotherapy)

EXPERIMENTAL

Patients in escalation and expansion, will receive NDI-101150 capsules orally once daily continuously in 4-week cycles (28 days).

Drug: NDI-101150

NDI-101150-Pembrolizumab (Combination therapy)

EXPERIMENTAL

Patients in escalation and expansion phase, will receive NDI-101150 capsules orally once daily continuously in 3-week cycles (21 days), along with pembrolizumab via intravenous (IV) infusion at a dose of 200 mg every 3 weeks.

Drug: NDI-101150; Drug: Pembrolizumab

Interventions

NDI-101150 DRUG

NDI-101150 capsules

NDI-101150 (Monotherapy); NDI-101150-Pembrolizumab (Combination therapy)

Pembrolizumab DRUG

Pembrolizumab IV infusion

NDI-101150-Pembrolizumab (Combination therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nimbus Saturn, Inc.: lead

Study Sites (19)

Honor Health Research Institute

Scottsdale, Arizona, 85258, United States

Location

Yale Cancer Center

New Haven, Connecticut, 06520, United States

Location

Georgetown University

Washington D.C., District of Columbia, 20007-2113, United States

Location

Ocala Oncology Center

Ocala, Florida, 34474, United States

Location

Norton Cancer Institute

Louisville, Kentucky, 40202, United States

Location

University of Maryland Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, 21201, United States

Location

Henry Ford Cancer

Detroit, Michigan, 48202, United States

Location

HealthPartners Cancer Research Center

Saint Paul, Minnesota, 55101, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Hackensack University

Hackensack, New Jersey, 07601, United States

Location

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

Location

Texas Oncology - Baylor Charles A. Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

Center for Oncology and Blood Disorders

Houston, Texas, 77030, United States

Location

Oncology Consultants

Houston, Texas, 77030, United States

Location

NEXT Oncology

San Antonio, Texas, 78229, United States

Location

NEXT Oncology

Fairfax, Virginia, 22031, United States

Location

Northwest Medical Specialties

Tacoma, Washington, 98405, United States

Location

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell; Kidney Neoplasms; Adenocarcinoma; Carcinoma, Non-Small-Cell Lung; Hereditary Sensory and Autonomic Neuropathies

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Nervous System Malformations; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Study Officials

• Anita Scheuber, MD

  Nimbus Saturn

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2021
• First Posted: November 22, 2021
• Study Start: November 5, 2021
• Primary Completion: February 1, 2025
• Study Completion: May 1, 2025
• Last Updated: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (19)