A Safety, Tolerability and Efficacy Study of NC410 Plus Pembrolizumab in Participants with Advanc… (NCT05572684) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
A Safety, Tolerability and Efficacy Study of NC410 Plus Pembrolizumab in Participants with Advanced Unresectable or Metastatic Solid Tumors
United States97 participantsStarted 2022-10-06
Plain-language summary
This is an open-label, non-randomized, Phase 1b/2 study to determine the safety and tolerability of NC410 when combined with a standard dose of pembrolizumab. This study will also assess the clinical benefit of combination therapy in participants with advanced unresectable and/or metastatic ICI refractory solid tumors OR ICI naĂŻve MSS/MSI-low solid tumors
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Be 18 years of age on day of signing informed consent.
* Participant with histologically or cytologically confirmed diagnosis of the following advanced unresectable and/or metastatic solid tumors:
* Phase 1b: Participants with solid tumors that are known to be associated as MSS/MSI-low in the majority including: CRC (without liver metastasis), Gastric including GE junction, Esophageal, Ovarian, and H\&N cancer (regardless of prior treatment with ICIs). Note: Participants must have had disease progression after at least one line of systemic standard of care therapy prior to enrollment. Participants who discontinue standard treatment due to intolerance or refuse standard treatment will also be eligible to enroll.
* Phase 2 ICI Refractory Solid Tumors (Cohort 1): Participants with solid tumors including CRC, Gastric including GE junction, Esophageal, Endometrial, H\&N, Lung, Cervical and Ovarian cancer.Participants must have progressed on treatment with an anti-PD1/L1 monoclonal antibody (mAb) administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies. PD-1 treatment progression is defined by meeting all of the following criteria:
* Has received at least 2 doses of an approved anti-PD-1/L1 mAb.
* Has demonstrated disease progression after PD-1/L1 as defined by RECIST v1.1.
* Phase 2 ICI naïve Solid Tumors (Cohorts 2a-2c):Tumors known to be associated with MSS/MSI-low status such as CRC, Gastric…
What they're measuring
1
Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0
Timeframe: 24 Months
2
Define a recommended Phase 2 dose (RP2D) of NC410 when combined with standard dose Pembrolizumab