APL-102 Capsule in Patients With Advanced Solid Tumors

NCT05055518 | Suspended Phase 1

• 1 other identifier: APL-102-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the safety and tolerability of APL-102 Capsule and characterize the pharmacokinetic (PK) profile in advanced solid tumor patients.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (2)

• DLT

  Dose limiting toxicities

  36 days

• Adverse Events (AEs)

  Adverse events occurred in all subjects during the study treatment according to the National Cancer Institute Common Terminology Standard for adverse events (NCI CTCAE) standard version 5.0

  From time of informed consent signature to 30 days after the subject's last visit (approximately 1 year)

Secondary Outcomes (8)

• Incidence of Adverse Events

  From time of informed consent signature to 30 days after the subject's last visit (approximately 1 year)

• Objective response rate(ORR)

  Approximately 1 year

• Duration of response(DOR)

  Approximately 1 year

• Progression-free survival(PFS)

  Approximately 1 year

• Overall survival(OS)

  Approximately 1 year

Study Arms (1)

A Phase I, open-labeled multicenter study

EXPERIMENTAL

APL-102 Capsules

Drug: APL-102 Capsules

Interventions

APL-102 Capsules DRUG

Dose escalation: A total of seven dose levels (1mg, 2mg, 3mg, 5mg, 7mg, 9mg and 11mg) are planned. Dose extension: After RP2D determined, the RP2D dose level will be extended to enroll 6-10 subjects to further evaluated the safety and antitumor activity of APL-102.

Also known as: No other name so far

A Phase I, open-labeled multicenter study

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, age ≥ 18 and ≤ 75 years old.
• Patients with unresectable or metastatic advanced solid tumors confirmed by histology or cytology, and after the failure of standard treatment, or cannot tolerate standard treatment, or have no standard treatment.
• There were measurable lesions according to the efficacy evaluation criteria of solid tumors (RECIST version 1.1).
• Eastern Cooperative Oncology Group(ECOG) performance status score is 0 to 1.
• Life expectancy is more than 3 months after the first administration.
• The organ function level must meet the following requirements:
• Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.0× upper limit of normal value (ULN) (patients with liver metastasis≤ 5 × ULN). Serum bilirubin ≤ 1.5×ULN (total bilirubin ≤ 3×ULN in patients with Gilbert syndrome). Absolute neutrophil count ≥ 1.5×10\^9/L. Platelet count ≥ 100×10\^9/ L. Hemoglobin ≥ 9 g / dL.
• No other chemotherapy was received within four weeks before the first administration of the trial; All previous anti-tumor treatments, including targeted therapy and endocrine therapy, shall pass through at least five half-lives (or no more than 28 days) after receiving targeted therapy/endocrine therapy, and patient shall recover to the standard level specified in the test from the toxic reaction of the treatment.
• For patients who have received radiotherapy for spine and/or peripheral limbs, they can only be enrolled after four weeks and two weeks before the first administration and should recover from the toxic reaction of treatment to the standard level specified in the study.
• No major surgery was performed within four weeks before the first administration of APL-102., etc.

You may not qualify if:

• In addition to the malignancies in the study, patients with systemic diseases leading to poor medical risk (such as uncontrollable infection in the active phase).
• Life-threatening diseases, severe organ dysfunction, interference with the absorption or metabolism of APL-102, or other reasons that the researchers believe may endanger the safety of subjects or affect the integrity of research results.
• Patients with a history of heart disease or potential risk of heart disease.
• Patients with low circulatory function as defined by the New York Heart Association's (NYHA) functional criteria.
• Patients with a definite diagnosis of chronic obstructive pulmonary disease, bronchial asthma or interstitial lung disease, or patients with forced expiratory volume in one second/ forced vital capacity (FEV1/FVC) ratio \< 70% in pulmonary function test.
• Patients with decompensated cirrhosis or history of allogeneic bone marrow transplantation or organ transplantation.
• Patients in repeated resting states during screening had mean systolic blood pressure ≥140 mmHg, diastolic blood pressure ≥90 mmHg, or positive proteinuria (allowing antihypertensive agents to control blood pressure).
• Have a history of human immunodeficiency virus (HIV) infection or HIV antibody positive; or seropositive results consistent with active infection for hepatitis B virus (in case of only hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive, the examination of Hepatitis B (HBV) DNA copy number is needed: HBV DNA copy number must not exceed 1,000 copies/mL or 200 IU/mL.) or hepatitis C virus.
• Patients with the symptomatic primary brain tumor and/or secondary brain metastasis, uncontrollable antiepileptic drugs and requiring high-dose steroid treatment. Or cerebrovascular accident, transient ischemic attack, or intermittent claudication within six months before treatment.
• Pregnant or lactating patients., etc.

Sponsors & Collaborators

• Apollomics Inc.: lead
• Zhejiang CrownMab Biotech Co. Ltd: collaborator

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, China

Location

Study Officials

• Yihebali Chi, PhD

  Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be assigned to a dose level of APL-102 in the order of study entry. A total of seven therapeutic dose levels (1mg, 2mg, 3mg, 5mg, 7mg, 9mg and 11mg) are planned. To reduce the number of subjects exposed to potentially ineffective doses and protect the rights and interests of subjects, rapid titration was used in the low-dose group (1 mg, 2 mg, 3 mg); When approaching the expected effective dose of 5 mg, the "3 + 3" study design was used.

Study Record Dates

• First Submitted: August 22, 2021
• First Posted: September 24, 2021
• Study Start: August 2, 2021
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)