Protocol Summary

Protocol No.

141062 (JAB-3312-1003)

Principal Investigator

Florou, Vaia

Phase

I/II

Age Group

Adult

ClinicalTrials.Gov

NCT04720976 (Click to jump to clinicaltrials.gov)

Eligibility Detail

Contact

Title

Phase I/IIA, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-3312 in Combination with Pembrolizumab or Binimetinib in Adult Patients with Advanced Solid Tumors

Objective

Primary
* To assess the safety and tolerability and determine the RP2D of JAB-3312 in combination with pembrolizumab or binimetinib in patients with advanced solid tumors
Secondary
* To assess preliminary efficacy of JAB-3312 in combination with pembrolizumab or binimetinib, as measured by RECIST v1.1 * To determine the PK profiles of JAB-3312 after a single dose and at steady state after multiple doses in combination with pembrolizumab or binimetinib
Exploratory
* To assess exploratory efficacy of JAB-3312 in combination with pembrolizumab by iRECIST criteria * To explore immunological biomarkers in tumor tissue (PD-L1 expression, CD163 expression, TMB) and blood (TMB, chemokine expression) that predict treatment response and resistance * To investigate molecular biomarkers in tumor tissue (KRAS mutation, MAPK pathway signature, DUSP6 expression, pERK expression) and blood (KRAS mutation) that may be predictive of clinical response or resistance, safety, MOA, and PD activity. * To explore relationships between PK and relevant PD and safety endpoints

Applicable Disease Sites

Experimental Therapeutics

Participating Institutions

Huntsman Cancer Institute

Status

Open


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