A Study to Investigate the Safety, Pharmacokinetics, and Clinical Activity of AP203 in Patients with Locally Advanced or Metastatic Solid Tumors, and Expansion to Selected Malignancies

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

168

Participants

Timeline

Start Date

July 24, 2023

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2027

Conditions
Locally Advanced or Metastatic Solid TumorsNon Small Cell Lung Cancer (NSCLC)Head and Neck Squamous Cell Carcinoma (HNSCC)Esophageal Squamous Cell Carcinoma (ESCC)
Interventions
DRUG

AP203

"Eight dose levels ranging from 0.00064 to 20 mg/kg will be evaluated to determine the maximum tolerated dose (MTD) or the maximum administered dose (MAD) or the recommended phase 2 dose(s) (RP2D\[s\]).~Participants will be administered by intravenous (IV) infusion, every week (Q1W \[± 1days\]) for the first 3 weeks (from the first to the fourth dose), then administered every 2 weeks (Q2W \[± 3 days\]) for all the following doses."

DRUG

AP203

The dose-expansion phase will be conducted following completion of dose escalation for AP203. Participants will receive AP203 by IV infusion, administered Q1W (± 1 days) for the first 3 weeks (from the first to the fourth dose), then administered Q2W (± 3 days) for all the following doses, at the RP2D for each expansion cohort.

Trial Locations (1)

115011

RECRUITING

AP Biosciences Inc., Taipei

Sponsors
All Listed Sponsors
lead

AP Biosciences Inc.

INDUSTRY