NCT06839105

A Clinical Study to Evaluate the Safety and Tolerability of AWT020 in Patients With Advanced Malignancies

A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AWT020 Alone and in Combination With Other Antitumor Therapies in Patients With Advanced Malignancies

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 214 (estimated)
• Sponsor: Shanghai Junshi Bioscience Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this phase I clinical study was to evaluate the safety and tolerability of AWT020 monotherapy and combination with other antitumor therapies in patients with advanced malignancies

Conditions

• Non-Small Cell Lung Cancer, Colorectal Cancer, Renal Cell Carcinoma, Melanoma and Other Solid Tumor

Interventions

Type	Name	Description
DRUG	Taxol	135\~175 mg/m2, Q3W
DRUG	Cisplatin or Carboplatin	Cisplatin(75 mg/m2, Q3W) or Carboplatin (AUC=5\~6, Q3W)
DRUG	Pemetrexed	500 mg/m2, Q3W
DRUG	Oxaliplatin	130 mg/m2, Q3W
DRUG	Capecitabine	1000 mg/m2, BID, day1-14, oral, q3w
DRUG	Bevacizumab	7.5 mg/kg, Q3W
DRUG	Renvastinib	8mg or 20mg, QD
DRUG	AWT020	q3w or q2w, i.v.

Timeline

• Start date: 2025-02-21
• Primary completion: 2028-04-30
• Completion: 2028-04-30
• First posted: 2025-02-21
• Last updated: 2025-05-31

Locations

13 sites across 1 country: China