A Phase I Clinical Study of APG-115 Alone or in Combination With APG-2575 in Children With Recurrent or Refractory Neuroblastoma or Solid Tumors

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 18
Healthy Volunteers: f
View:

• Recurrent or refractory neuroblastoma or solid tumor.

• Physical state score ≥ 50.

• Expected survival ≥ 3 months.

• There are target lesions (neuroblastoma) or measurable lesions (other solid tumors).

• Have adequate organ function.

• Fresh or archived tumor tissue samples should be provided prior to treatment. If none of these specimens are available, inclusion may be made after consultation with the sponsor.

• Fertile women (≥14 years of age or having menarche) must have a negative serum pregnancy test at the time of the screening visit and must not be breastfeeding or planning to become pregnant during the study period.

• A potentially fertile male subject (who has spermatoses) or female subject (ibid.) must agree to use effective contraception during the trial period and for 3 months after the trial ends (or is prematurely discontinued).

• Informed consent must be obtained before carrying out any study procedure specified in the test. For child subjects, the consent of the subject and one of the parent/legal guardian must be obtained.

⁃ The ability to swallow research drugs.

Locations
Other Locations
China
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
Tianjin Medical University Cancer Institute & Hospital
RECRUITING
Tianjin
Tongji Hospital, Huazhong University of Science and Technology (HUST)
RECRUITING
Wuhan
Contact Information
Primary
Yifan Zhai, MD,PHD
Yzhai@ascentage.com
+86-20-28068501
Backup
Yan Yu
Yan.Yu@ascentage.com
Time Frame
Start Date: 2023-02-28
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 100
Treatments
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.
Sponsors
Leads: Ascentage Pharma Group Inc.
Collaborators: Suzhou Yasheng Pharmaceutical Co., Ltd.

This content was sourced from clinicaltrials.gov

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