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

Sponsor
Shanghai Junshi Bioscience Co., Ltd.
Study ID
NCT06839105
Phase
PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

First listed
Feb 21, 2025
Start date
Feb 21, 2025
Status verified
Jul 2026
Primary completion
Apr 30, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
214 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: AWT020
    If needed, additional descriptive information (including which interventions are administered in each arm) to differentiate each arm from other arms in the clinical trial.
  • Experimental: AWT020 combination with taxol and cisplatin or carboplatin
  • Experimental: AWT020 combination with Pemetrexed and cisplatin or carboplatin
  • Experimental: AWT020 combination with Oxaliplatin,Capecitabine and Bevacizumab
  • Experimental: AWT020 combination with Renvastinib

Primary Outcome Measure

DLT rate [ Time Frame: Up to approximately 12 months from first patient in ]

Central Contacts