A Study of NDI 1150-101 in Patients With Solid Tumors (NCT05128487) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
A Study of NDI 1150-101 in Patients With Solid Tumors
United States106 participantsStarted 2021-11-05
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 w…
What they're measuring
1
Part 1: Frequency of dose-limiting toxicities (DLTs)