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

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ClinicalTrials.gov Identifier: NCT05128487
Recruitment Status : Recruiting
First Posted : November 22, 2021
Last Update Posted : March 29, 2024
Sponsor:
Information provided by (Responsible Party):
Nimbus Therapeutics ( Nimbus Saturn, Inc. )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Solid Tumor Drug: NDI-101150 Drug: Pembrolizumab Phase 1 Phase 2

Detailed Description:

This is a multicenter, open-label, first-in-human, Phase 1/2 study.

The study will consist of 2 phases:

  • The Dose Escalation Phase: designed to evaluate the safety and tolerability of NDI-101150 as monotherapy (Arm 1) and in combination with pembrolizumab (Arm 2) in patients with advanced solid tumors.
  • The Dose Expansion Phase: designed to evaluate the safety and efficacy of NDI-101150 as monotherapy (Arm 1) and in combination with pembrolizumab (Arm 2) in disease-specific dose expansion cohorts: gastric and gastroesophageal junction [GEJ] cancer, non-small cell lung cancer [NSCLC], and renal cell carcinoma [RCC].

Each phase of the study will consist of 3 periods:

  • A Screening period of up to 28 days during which patient eligibility will be reviewed and approved by the Sponsor.
  • Treatment period that will extend from Cycle 1 Day 1 until progression of disease (PD), unacceptable toxicity, withdrawal of consent, start of a new systemic anticancer treatment, discontinuation of the patient by the Investigator, or termination of the study by the Sponsor. This will also include Safety Follow-up Visit 30 days [+3 days] after the last dose of investigational medicinal product.
  • Post treatment Follow-up period which will continue until lost to follow-up, withdrawal of consent, or the End of the Study (whichever comes first).
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 106 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2, Open-label Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of NDI-101150 Administered as Monotherapy or in Combination With Pembrolizumab in Patients With Solid Tumors
Actual Study Start Date : November 5, 2021
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: NDI-101150 (Monotherapy)
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 capsules
Experimental: NDI-101150-Pembrolizumab (Combination therapy)
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
NDI-101150 capsules

Drug: Pembrolizumab
Pembrolizumab IV infusion


Outcome Measures
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Primary Outcome Measures :
  1. Part 1: Frequency of dose-limiting toxicities (DLTs) [ Time Frame: Cycle 1 (28 days) ]
  2. Part 2: Objective response rate (ORR) [ Time Frame: Up to approximately 34 months ]

Secondary Outcome Measures :
  1. Part 1 and Part 2: Number of patients with adverse events (AEs) and Serious adverse events (SAEs) [ Time Frame: From Screening (Day -28 to Day -1) until safety follow-up (>30 days after last dose) [Assessed up to 37 months] ]
  2. Part 1 and Part 2: Maximum plasma concentration (Cmax) of NDI-101150 [ Time Frame: 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) ]
  3. Part 1 and Part 2: Time to maximum plasma concentration (tmax) of NDI-101150 [ Time Frame: 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) ]
  4. Part 1 and Part 2: Area under the concentration-time curve from time zero to the last observable concentration (AUC0-t) of NDI-101150 [ Time Frame: 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) ]
  5. Part 1 and Part 2: Area under the concentration-time curve extrapolated to infinity (AUC0-∞) of NDI-101150 [ Time Frame: 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) ]
  6. Part 1: Objective response rate (ORR) [ Time Frame: Assessed up to 37 months ]
  7. Part 1 and Part 2: Progression-free survival (PFS) [ Time Frame: From first dose until confirmed progression of disease (PD) or death (Assessed up to 37 months) ]
  8. Part 1 and Part 2: Duration of response (DOR) [ Time Frame: Time from first response until confirmed PD (Assessed up to 37 months) ]
  9. Part 1 and Part 2: Time to response (TTR) [ Time Frame: Time from first dose until first response (Assessed up to 37 months) ]
  10. Part 2: Overall survival [ Time Frame: Assessed up to 37 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • 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 Exclusion Criteria:

  • 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 Exclusion criteria may apply.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05128487


Contacts
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Contact: Study Coordinator 8579992009 clinical@nimbustx.com

Locations
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Sponsors and Collaborators
Nimbus Saturn, Inc.
Investigators
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Study Director: Bhaskar Srivastava, MD Nimbus Saturn
More Information
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Responsible Party: Nimbus Saturn, Inc.
ClinicalTrials.gov Identifier: NCT05128487    
Other Study ID Numbers: 1150-101
First Posted: November 22, 2021    Key Record Dates
Last Update Posted: March 29, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nimbus Therapeutics ( Nimbus Saturn, Inc. ):
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
Additional relevant MeSH terms:
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Neoplasms
Pembrolizumab
Antineoplastic Agents, Immunological
 Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action