NCT04720976

JAB-3312 Based Combination Therapy in Adult Patients With Advanced Solid Tumors

A Phase 1/2a, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-3312 Based Combination Therapies in Adult Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Allist Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and tolerability of JAB-3312 administered in investigational regimens in adult participants with advanced solid tumors.

Detailed description

To assess the safety and tolerability and determine the Recommended phase 2 dose (RP2D) of JAB-3312 in combination with PD1 inhibitor or MEK inhibitor in patients with advanced solid tumors.

Conditions

• Solid Tumor
• NSCLC

Interventions

Type	Name	Description
DRUG	JAB-3312	JAB-3312 will be administered orally, variable dose.
DRUG	Binimetinib	Binimetinib will be administered orally.
DRUG	Pembrolizumab	Pembrolizumab will be administered as an intravenous infusion.
DRUG	Sotorasib	Sotorasib will be administered orally.
DRUG	Osimertinib	Osimertinib will be administered orally.

Timeline

• Start date: 2021-03-23
• Primary completion: 2023-12-19
• Completion: 2023-12-19
• First posted: 2021-01-22
• Last updated: 2025-04-11

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated drug study