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Solid TumorPhase 1/2NCT05128487

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

A Phase 1/2 study testing NDI-101150 and Pembrolizumab in people with Solid Tumor and Renal Cell Carcinoma (Kidney Cancer), run by Nimbus Saturn, Inc. at 19 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
NDI-101150 and Pembrolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
19 sitesUnited States
Study dates
5 Nov 2021to May 2025
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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.

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

United States19 sites

  • University of Maryland Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland, 21201

  • Texas Oncology - Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

  • Henry Ford Cancer

    Detroit, Michigan, 48202

  • NEXT Oncology

    Fairfax, Virginia, 22031

  • Hackensack University

    Hackensack, New Jersey, 07601

  • Center for Oncology and Blood Disorders

    Houston, Texas, 77030

  • Oncology Consultants

    Houston, Texas, 77030

  • Norton Cancer Institute

    Louisville, Kentucky, 40202

  • University of Wisconsin

    Madison, Wisconsin, 53705

  • Yale Cancer Center

    New Haven, Connecticut, 06520

  • Columbia University Irving Medical Center

    New York, New York, 10032

  • Ocala Oncology Center

    Ocala, Florida, 34474

  • Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

  • HealthPartners Cancer Research Center

    Saint Paul, Minnesota, 55101

  • NEXT Oncology

    San Antonio, Texas, 78229

  • Honor Health Research Institute

    Scottsdale, Arizona, 85258

  • Washington University

    St Louis, Missouri, 63110

  • Northwest Medical Specialties

    Tacoma, Washington, 98405

  • Georgetown University

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

Other trials in United States

About this study

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

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.

Read the 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).
Being tested
NDI-101150, Pembrolizumab
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
Medical subject headings
Carcinoma, Renal Cell, Kidney Neoplasms, Adenocarcinoma, Carcinoma, Non-Small-Cell Lung, Hereditary Sensory and Autonomic Neuropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NDI-101150Drug

    NDI-101150 capsules

  • PembrolizumabDrug

    Pembrolizumab IV infusion

Study groups in NCT05128487
Study groupRoleWhat they receive
NDI-101150 (Monotherapy)ExperimentalPatients in escalation and expansion, will receive NDI-101150 capsules orally once daily continuously in 4-week cycles (28 days).
Receives: Drug: NDI-101150
NDI-101150-Pembrolizumab (Combination therapy)ExperimentalPatients 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.
Receives: Drug: NDI-101150; Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Cycle 1 (28 days)

  2. Part 2: Objective response rate (ORR)

    Measured: Up to approximately 34 months

Secondary outcomes (10)

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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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)

    Measured: Assessed up to 37 months

  7. Part 1 and Part 2: Progression-free survival (PFS)

    Measured: 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)

    Measured: Time from first response until confirmed PD (Assessed up to 37 months)

  9. Part 1 and Part 2: Time to response (TTR)

    Measured: Time from first dose until first response (Assessed up to 37 months)

  10. Part 2: Overall survival

    Measured: Assessed up to 37 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2021
  2. Study start5 Nov 2021
  3. Primary completionFeb 2025 (estimated)
  4. Study completionMay 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
106 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05128487
Sponsor's protocol ID
1150-101
Status last verified
Nov 2024
First submitted
22 Oct 2021
Last updated
25 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Braun DA, Noel MS, Moy RH, Demel K, Gutierrez M, Sharma S, Hussain A, Gadgeel S, Peguero J, Choueiri TK, Emamekhoo H, Van Tine B, Balaraman R, Elliott G, Nath S, Daigle SR, Kumar P, Scheuber A, Sommerhalder D. HPK1 inhibitor NDI-101150 as monotherapy and in combination with pembrolizumab in patients with advanced solid tumors: Phase 1/2 trial results. Cell Rep Med. 2026 May 19;7(5):102789. doi: 10.1016/j.xcrm.2026.102789. Epub 2026 May 6.

    PubMed 42097144

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing NDI-101150 and Pembrolizumab in people with Solid Tumor and Renal Cell Carcinoma (Kidney Cancer), run by Nimbus Saturn, Inc. at 19 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Frequency of dose-limiting toxicities (DLTs) (time frame: Cycle 1 (28 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05128487, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.

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