APG-115 Alone or in Combination With APG-2575 in Children With Recurrent or Refractory Neuroblastoma or Solid Tumors

Sponsor
Ascentage Pharma Group Inc.
Study ID
NCT05701306
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • APG-115 — DRUG
    Orally once every other day(QOD) for 2 weeks and suspended for 1 week, 21 days as a cycle.
  • APG-2575 — DRUG
    Orally once a day (QD) for 21 days, 21 days as a cycle.

Study Details

An open, non-randomized Phase I trial of dose-escalation and cohorts expansion to evaluate the safety, pharmacokinetic profile and initial efficacy of APG-115 alone or in combination with APG-2575 in the treatment of recurrent or refractory pediatric neuroblastoma or solid tumors.

Key Dates

First listed
Jan 27, 2023
Start date
Feb 28, 2023
Status verified
Feb 2025
Primary completion
Jun 1, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: APG-115 monotherapy in part1
    Multiple dose cohorts, to determine the RP2D of APG-115.
  • Experimental: APG-115 combined with APG-2575 in part2
    Multiple dose cohorts of APG-2575, to determine the RP2D of APG-2575 combined with APG-115.

Primary Outcome Measure

Dose Limiting Toxicity (Phase I) [ Time Frame: Up to 21 days ]

Central Contacts

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