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BA1301

Phase 1

Advanced Solid Tumours | Small molecule | Oncology |Co-Diagnostics, Inc.|Last Updated: Apr 15, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment70
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06927349A Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BA1301 in Advanced Solid Tumors.PHASE1 RECRUITING 70Jan 11, 2023Dec 31, 2026Apr 15, 20251 China
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Study Endpoints
Primary Endpoints
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (according to NCI CTCAE 5.0).
From the initiation of study treatment to the completion of safety follow-up after the end of study treatment, up to 2 years.
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BA1301EXPERIMENTALBA1301 is administered intravenously once every three weeks.
Interventions
NameTypeDescription
BA1301DRUGBA1301 is administered intravenously once every three weeks.
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Voluntarily signed informed consent and able to follow the trial treatment protocol and visit plan; 2. Age ≥ 18 years old and ≤ 75 years old, male or female; 3. Patients with locally advanced or metastatic malignant solid tumours that cannot be surgically resected as histolog...

Countries:China
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