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

  • STATUS
    Recruiting
  • End date
    Dec 5, 2024
  • participants needed
    106
  • sponsor
    Nimbus Saturn, Inc.
Updated on 5 June 2022

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 male and female patients with advanced solid tumors.

Description

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

In this 2 parts study, eligible patients will be enrolled in Part 1 (Dose Escalation Phase: designed to evaluate the safety and tolerability of NDI-101150 as monotherapy and in combination with pembrolizumab) and Part 2 (Dose Expansion Phase: designed to evaluate the safety and efficacy of NDI-101150 as monotherapy and in combination with pembrolizumab in disease-specific (gastric and gastroesophageal junction [GEJ] cancer) dose expansion cohorts).

Each part of the study will consist of 3 phases:

  • A Screening Phase of up to 28 days during which patient eligibility will be reviewed and approved by the Sponsor.
  • Treatment Phase 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 (and will include Safety Follow-up Visit 30 days [+3 days] after the last dose of investigational medicinal product).
  • Post treatment Follow-up Phase which will continue until lost to follow-up, withdrawal of consent, or the End of the Study (whichever comes first).

Details
Condition Solid Tumor
Treatment Pembrolizumab, NDI-101150
Clinical Study IdentifierNCT05128487
SponsorNimbus Saturn, Inc.
Last Modified on5 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Life expectancy of ≥ 12 weeks
Measurable or non-measurable disease for Part 1; measurable disease using RECIST v1.1 is required for Part 2
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 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 Part 2, willing to consent to required tumor biopsy(ies)
For Part 1 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 Part 2 (Dose Expansion, Monotherapy and Combination Therapy): Histologically or cytologically confirmed advanced or metastatic gastric or GEJ adenocarcinoma for which no standard therapy is available or are refractory to standard therapy

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 treatment
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 progressive requiring treatment
Unstable or severe uncontrolled medical condition (e.g., unstable cardiac function, unstable pulmonary condition, uncontrolled diabetes) or any important medical or psychiatric illness or abnormal laboratory finding
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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