A Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of the Combination of BAT8008 With BAT1308 in Patients With Advanced Solid Tumors

StatusActive, Not Recruiting
PhasePhase 1/2
Started

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Trial flagged as At Risk
Primary completion moved at least 7 months later Apr 3, 2026 → Nov 30, 2026
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Record History

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  1. Primary completion pushed from Apr 3, 2026 to Nov 30, 2026
    • Study completion pushed from Jul 28, 2026 to Nov 30, 2026
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 1 of 6 entries
  2. Study arms: 1 to 6v7
  3. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v6
  4. Re-verified, no change to tracked fieldsv5
  5. Enrollment target: 204 to 112v4
Show 2 earlier versionsHide 2 earlier versions
  1. Enrollment target: 50 to 204v3
  2. Trial status: Not Yet Recruiting to Recruitingv2
  1. 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.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The study, led by Zhejiang Cancer Hospital and sponsored by Bio-Thera Solutions, Ltd., is an exploratory multicenter, open-label phase Ib-II clinical trial evaluating the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of the combination of BAT8008 with BAT1308 in patients with advanced solid tumors. This study aims to explore the safety, tolerability, and pharmacokinetic characteristics of BAT8008 combined with BAT1308 in patients with advanced solid tumors, determine the maximum tolerated dose (MTD), provide recommended doses and reasonable dosing regimens for subsequent clinical studies, and preliminarily evaluate the antitumor efficacy. The study is divided into two stages. The first stage will use a "3+3" dose escalation design to explore the safety and tolerability of the investigational drugs. In the second stage, based on the preliminary safety and efficacy results from the first stage, appropriate doses and tumor types will be selected for expansion studies within the safety dose range to further investigate the safety and clinical efficacy of BAT8008+BAT1308 and provide evidence for subsequent clinical studies.
Trial Details
NCT Number NCT06341114
Lead Sponsor Bio-Thera Solutions
Conditions
(from sponsor)		 Advanced Solid Tumors
Enrollment 112 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov