Clinical Trial: NCT05128487
A Study of NDI 1150-101 in Patients With Solid Tumors
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 1| Lead Sponsor: | Nimbus Saturn, Inc. |
| Information Provided By: | Nimbus Therapeutics |
| Last Update Posted: | 2024-11-25 |
Study Overview
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.
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
Conditions
Solid Tumor, Renal Cell Carcinoma (Kidney Cancer), Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma, Non-Small Cell Lung Cancer
Intervention / Treatment
- Drug: NDI-101150
- Drug: Pembrolizumab
Other Study ID Numbers
- 1150-101
Start Date (Actual)
2021-11-05
Primary Completion Date (Estimated)
2025-02
Study Completion Date (Estimated)
2025-05
Enrollment (Estimated)
106
Study Type
Interventional
Phase
Phase 1, Phase 2
| Lead Sponsor: | Nimbus Saturn, Inc. |
| Information Provided By: | Nimbus Therapeutics |
| Last Update Posted: | 2024-11-25 |
Study Overview
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.
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
Conditions
Solid Tumor, Renal Cell Carcinoma (Kidney Cancer), Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma, Non-Small Cell Lung Cancer
Intervention / Treatment
- Drug: NDI-101150
- Drug: Pembrolizumab
Other Study ID Numbers
- 1150-101
Start Date (Actual)
2021-11-05
Primary Completion Date (Estimated)
2025-02
Study Completion Date (Estimated)
2025-05
Enrollment (Estimated)
106
Study Type
Interventional
Phase
Phase 1, Phase 2