A Multicenter Open Clinical Study of Safety, Tolerability, Pharmacokinetic Profile, and Initial Clinical Efficacy of BAT 8010 for Injection Combined With BAT 1006 in the Treatment of Locally Advanced or Metastatic Tumors

StatusActive, Not Recruiting
PhasePhase 1/2
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 3 months later Nov 9, 2026 → Feb 29, 2028
See other at-risk trials from Bio-Thera Solutions

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Nov 9, 2026 to Feb 29, 2028 Show 6 more changesShow less
    • Enrollment closed, study ongoing
    • Study completion pushed from Dec 9, 2026 to May 30, 2028
    • Enrollment target: 216 to 218
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 1 of 6 entries
    • Site details revised
  2. Re-verified, no change to tracked fieldsv5
  3. Primary completion date: Dec 24, 2024 to Nov 9, 2026v4
  4. Enrollment target: 108 to 216v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: May 24, 2024 to Dec 24, 2024
    • Start date changed from estimate of Apr 30, 2024 to May 8, 2024
    • Study title shortened, about 5 words
    v2
  6. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
This study is a multicenter, open, exploratory Phase Ib/IIa clinical trial in humans The combination of BAT8010 and BAT1006 was administered in patients with locally advanced or metastatic solid tumors(HER-2 expression, including IHC3+, IHC2+/FISH+, and IHC2+/FISH- patients)Tolerance and PK characteristics, to explore the maximum tolerated dose (MTD) and provide recommendations for subsequent clinical studies Recommended dose (RP2D) and rational administration regimen, and preliminary evaluation of antitumor efficacy. There are two main studies In the first stage, the "3+3" dose escalation rule is proposed to explore the safety and tolerance of the drug Sex; The second stage selects the appropriate dose and administration according to the preliminary safety and efficacy results of the previous stage The drug regimen and tumor species were expanded to further explore the combination of BAT8010 and BAT1006 for injection，The safety and clinical effectiveness of drug administration provided the basis for the follow-up clinical study.
Trial Details
NCT Number NCT06376136
Lead Sponsor Bio-Thera Solutions
Conditions
(from sponsor)		 Advanced Solid Tumors
Enrollment 218 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov