The Efficacy and Safety of CKD516 Combined With Durvalumab in Patient Refractory Solid Tumors

Sponsor
Tae Won Kim
Study ID
NCT04696848
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • CKD-516 plus Durvalumab — DRUG
    Stage 1 : dose escalation durvalumab (1500 mg Q4W) in combination with CKD-516 at 1 of 3 planned dose levels (9, 11, or 13 mg/m2 twice a week for 3 weeks in each cycle, Q4W). Stage 2 : durvalumab (1500 mg Q4W) in combination with CKD-516 at recommended phase 2 dose (twice a week for 3 weeks in each cycle, Q4W).

Study Details

This is a single center, open-label, nonrandomized, Phase 1b, dose-escalation study designed to determine maximum tolerated dose (MTD) of CKD-516 in combination with durvalumab and evaluate the safety and tolerability profile, efficacy of CKD-516 and durvalumab treatment.

Key Dates

Start date
Feb 24, 2021
Status verified
Apr 2023
Primary completion
Mar 9, 2023
Completion
Mar 9, 2023

Study Design

Enrollment
25 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CKD-516 plus Durvalumab
    Stage 1 : dose escalation durvalumab (1500 mg Q4W) plus CKD-516 at dose levels (9, 11, or 13 mg/m2) Stage 2 : durvalumab (1500 mg Q4W) plus CKD-516 at recommended phase 2 dose

Primary Outcome Measure

Maximum tolerated dose [ Time Frame: 4 weeks ]

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