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CSCJC3456

Phase 1

Advanced Malignant Solid Tumors | Small molecule | Oncology |Co-Diagnostics, Inc.|Last Updated: Feb 2, 2026

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 Enrollment102
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06717750A Study of CSCJC3456 in Patients With Advanced Malignant TumorsPHASE1 RECRUITING 102 — — Feb 13, 2025Jun 30, 2028Feb 2, 20262 China
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Study Endpoints
Primary Endpoints
Phase Ia: Dose Limiting Toxicity (DLT)
From first dosing at cycle 0 to the end of cycle 1. Cycle 0 has 3 days, and cycle 1 has 21 days.

Number and proportion of individuals experiencing DLT. According to the NCI-CTCAE V5.0 toxicity evaluation criteria, DLT is defined as a certain level of toxicity related to the study drug (including definitely related, probably related, and possibly related) occurring during the first treatment cycle (C0D1\~C1D21) of single and multiple administrations.

Phase Ia: Maximum Tolerated Dose (MTD)
From first dosing at cycle 0 to the end of cycle 1. Cycle 0 has 3 days, and cycle 1 has 21 days.

MTD is defined as the maximum dose at which the number of cases with DLT is ≤1/6 during the DLT observation period. To determine MTD, 6 evaluable participants are required.

Phase Ia: Assessment of safety and toxicity profile
From enrollment until the 28 days after the last study dose.

Number of participants who experienced AEs, SAEs, and changes in physical examination, vital signs, ECOG score, imaging examination, laboratory tests, and 12-lead electrocardiogram, etc.

Phase Ib: Objective Response Rate (ORR)
From enrollment to the date of first documented progression or death due to any cause, whichever came first (up to approximately 2 years).

ORR is defined as the proportion of participants whose tumors have achieved complete response (CR) and partial response (PR) after treatment, with response confirmed at least 4 weeks after the first assessment of CR or PR.

Secondary Endpoints
Phase Ia and Phase Ib: Terminal Phase Half-life (t1/2 )
From enrollment to the end of cycle 1, phase Ia includes cycles 0 and 1, while phase Ib includes cycle 1. Cycle 0 has 3 days, and cycle 1 has 21 days.
Phase Ia and Phase Ib: Maximum plasma concentration (Cmax)
From enrollment to the end of cycle 1, phase Ia includes cycles 0 and 1, while phase Ib includes cycle 1. Cycle 0 has 3 days, and cycle 1 has 21 days.
Phase Ia and Phase Ib: Time to reach Cmax (tmax)
From enrollment to the end of cycle 1, phase Ia includes cycles 0 and 1, while phase Ib includes cycle 1. Cycle 0 has 3 days, and cycle 1 has 21 days.
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
CSCJC3456 monotherapyEXPERIMENTAL* Phase Ia: Single and Multiple Dose Escalation. * Phase Ib: Cohort Expansion.
Interventions
NameTypeDescription
CSCJC3456 tabletDRUG* Phase Ia: Single and Multiple Dose Escalation. 1. Dosage form: tablet. 2. Dosage: 7 dose groups, 5 mg, 15 mg, 30 mg, 45 mg, 60 mg, 80 mg, 100 mg. 3. Frequency: once daily (tentative), or twice daily and other options (adjusted based on the results of the preliminary trials). 4. Duration: 5 mg(days 1-28; 28 days per cycle), other groups (days 1-14; 21 days per cycle) . * Phase Ib: Cohort Expansion. Dosage and dosing regimen: according to the recommended dosage and dosing cycle from the Phase Ia study.
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. Voluntarily sign the informed consent form and follow protocol requirements; 2. Aged 18 to 75 (both inclusive), male or female, regardless of race; 3. Expected survival period ≥ 12 weeks; 4. ECOG PS score ≤1; 5. Phase Ia study: ● Participants with advanced malignant solid...

Countries:China
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