RecruitingPhase 1NCT06839105

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


Sponsor

Shanghai Junshi Bioscience Co., Ltd.

Enrollment

214 participants

Start Date

Feb 21, 2025

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new cancer drug to evaluate its safety, how well it's tolerated, and early signs of whether it works. It targets several types of advanced cancers including non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), and other solid tumors that have not responded to standard treatments. **You may be eligible if...** - You are 18 years old or older - You have advanced cancer confirmed by lab tests that has progressed after standard treatments, or no standard treatment is available - You have adequate organ function and overall health - Specific cancer types are being enrolled, including NSCLC, TNBC, and others **You may NOT be eligible if...** - You have untreated brain metastases - You have active autoimmune disease or are on immunosuppressants - You have had certain prior treatments that would interfere with the study drug - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTaxol

135\~175 mg/m2, Q3W

DRUGCisplatin or Carboplatin

Cisplatin(75 mg/m2, Q3W) or Carboplatin (AUC=5\~6, Q3W)

DRUGPemetrexed

500 mg/m2, Q3W

DRUGOxaliplatin

130 mg/m2, Q3W

DRUGCapecitabine

1000 mg/m2, BID, day1-14, oral, q3w

DRUGBevacizumab

7.5 mg/kg, Q3W

DRUGRenvastinib

8mg or 20mg, QD

DRUGAWT020

q3w or q2w, i.v.


Locations(13)

Fujian Cancer Hospital

Fuzhou, Fujian, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

The First Affiliated Hospital of Henan University of Science & Technology

Luoyang, Henan, China

Hubei Cancer Hospital

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

The First Hospital of Jilin University

Changchun, Jilin, China

Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, China

The First Hospital of China Medical University

Shenyang, Liaoning, China

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Yunnan Cancer Hospital

Kunming, Yunnan, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT06839105