Study on NDI 1150-101 for Patients with Advanced Solid Tumors

Sponsor: Nimbus Saturn, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05128487

Provider View

This clinical trial is testing a new drug, NDI-101150, alone or with pembrolizumab, to find the best dose and check its safety and effectiveness in adults with advanced solid tumors.

Patient Parameters

Program Overview

The study aims to find the safest and most effective dose of a new drug, NDI-101150, when used alone or with pembrolizumab in adults with advanced solid tumors. Researchers will look at how the drug is processed in the body, its effects, and its ability to fight tumors.

Description

This study is being conducted at multiple centers and is the first time NDI-101150 is being tested in humans. It has two main parts:

  • Dose Escalation Phase: This part will test the safety of NDI-101150 alone (Arm 1) and with pembrolizumab (Arm 2) in patients with advanced solid tumors.
  • Dose Expansion Phase: This part will further test the safety and effectiveness of NDI-101150 alone and with pembrolizumab in specific groups of patients with gastric and gastroesophageal junction cancer, non-small cell lung cancer, and renal cell carcinoma.

Each phase includes three periods:

  • Screening Period: Lasts up to 28 days to check if patients qualify for the study.
  • Treatment Period: Starts on the first day of treatment and continues until the disease progresses, side effects become unacceptable, the patient withdraws, or the study ends. Includes a safety follow-up visit about 30 days after the last dose.
  • Post-Treatment Follow-Up Period: Continues until the patient is lost to follow-up, withdraws, or the study ends.

Eligibility Criteria

Inclusion Criteria

  • Expected to live at least 12 more weeks.
  • Have measurable or non-measurable disease for the first phase; measurable disease required for the second phase.
  • Recovered from previous treatments to a certain level, except for hair loss.
  • Good overall health with a performance status of 0 or 1.
  • Adequate bone marrow, kidney, and liver function.
  • Last cancer treatment was at least 4 weeks before starting NDI-101150.
  • For the first phase: Have advanced or metastatic solid tumors with no standard treatments available.
  • For the second phase: Willing to have a tumor biopsy and have specific types of cancer with no standard treatments available.

Exclusion Criteria

  • Have had a solid organ or bone marrow transplant.
  • Have untreated or active cancer in the brain or spinal cord.
  • Have had cancer treatment within 2-6 weeks before the study starts.
  • Have significant heart disease.
  • Have had severe allergic reactions to monoclonal antibodies (for combination therapy only).
  • Have lung diseases like interstitial lung disease or pneumonitis.
  • Have another active cancer needing treatment.
  • Have unstable or severe uncontrolled medical conditions.
  • Cannot stop taking certain medications that affect liver enzymes.
  • Have had severe immune-related side effects from previous treatments.

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