A Study of BL-ARC002 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumors and Other Solid Tumors

Sponsor
Sichuan Baili Pharmaceutical Co., Ltd.
Study ID
NCT07763652
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Gastrointestinal Tumors
  • Solid Tumors

Eligibility Criteria

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

Interventions

  • BL-ARC002 — DRUG
    Administration by intravenous infusion for a cycle of 6 weeks.

Study Details

This is an open-label, multicenter, non-randomized Phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of BL-ARC002 Injection in patients with locally advanced or metastatic solid tumors.

Key Dates

First listed
Aug 13, 2026
Start date
Aug 31, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
22 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: BL-ARC002
    Participants receive BL-ARC002 for the first cycle (6 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.

Primary Outcome Measure

Phase Ia: Dose limiting toxicity (DLT) [ Time Frame: Up to 42 days after the first dose ]

Central Contacts

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